If you are troubled by both allergies and asthma you might thinking, "if it weren't for bad luck I'd have no luck at all". The fact is that it is estimated that as many as sixty percent of the asthma cases in the U.S. are allergy related. You are not alone. There are many people like yourself who are suffering from the same double barreled malady. The fact is that allergies can induce or agrivate asthma. Both the lining of the nose and throat are susceptible to allergic reactions to molds. pollen and whatever els it is you may be allergic to. You may be suffering from allergy induced asthma and not even know it.
There is hope however. Ongoing research has made en roads into the connection between allergies and asthma. Over the years people who were treating their asthma with strictly asthma medications might have been treating the symptom and not the cause all along. Allergen immunotherapy has been shown to work on people with allergy induced asthma in many cases. For these people desensidation shots have been a blessing and have been successful of relieving them of their suffering by enabling their body to have the allergic reactions that were causing their asthma.
There are a number of medicines available that can help to reduce the inflammation in the throat of the asthma sufferer. The come in all forms from inhalers to pill form to injections and if your type of asthma is allergy induced they can be helpful in bringing you relief from allergy induced asthma. It is possible to have allergies and have asthma be your only reaction. That is, you need not show any other allergic reactions other that your allergy induced asthma. So you may be one of the many people out there suffering from allergy induced asthma who don't even know that this is the cause of their suffering.
Who is at risk of having allergy induced asthma? If you have a family history of allergies and also have asthma than you are at a higher risk than normal that your asthma is allergy induced asthma. Studies have shown that up to seventy-two percent of people who have asthma also have hay fever. This is not to say that all asthma cases are allergy induced asthma. There are in fact several other forms of asthma that are not allergy induced asthma. Other forms of asthma are exercise induced asthma, and non allergic asthma, triggered by cold air or asthma triggered by gastroesophogeal reflux disease. It is important that you determine what type of asthma you have.
The fact is that there is hope for all asthma sufferers. Ongoing research is developing new treatments for both allergy induced asthma and non allergic asthma. Many research scientists believe that a cure is on the horizon. In the absence of a complete cure though, great strides have been made in the treatment of the symptoms that make those who suffer from the malady miserable. Some have found a combination of treatment strategies to be the answer to their problem. Finding and removing the source of their allergy symptoms is of course the first step if at all possible. Many times this is the solution. The important thing is that you not give up your hunt for help.
About the Author
Article by Sven Ullmann, who runs Deserved Health - information on health for you and your family. Read more about popular asthma and allergies.
Wednesday, April 30, 2008
Tuesday, April 22, 2008
Going on the Offensive with Asthma in Children
Any condition or disease that affects children seems a lot worse for us as parents. While we only want the best for our kids, were almost powerless to protect them when facing many health-related conditions like asthma. Once a condition such as asthma has been diagnosed however, we can do everything in our power to see to it that they get the proper care that can make all the difference in their quality of life.
Asthma and other respiratory conditions are some of the bigger challenges parents can face. The reason is that asthma is a chronic condition that won't go away by simply taking medication. It's a long term illness that demands changes in a families lifestyle and living conditions if the asthmatic child is to live a normal life. While there seems to be severities of asthma, all cases demand special care.
Kids have been known to seemingly "grow out of" childhood asthma. It may be that their bodies have developed a way to overcome many of the triggers and sensitivities, or their respiratory tract has matured. Regardless of the reason, although not an honest cure, anything that results in fewer asthma attacks is a reason to celebrate
Asthma is especially difficult because of it's ongoing chronic nature. Respiratory conditions such as asthma can strike literally at any time and any place. Although very disconcerting to parents, adults can limit the severity and time of an episode by making certain that needed medications are available at the right time.
It's also very possible to lower the number and severity of attacks simply by limiting the exposure to the various things that can trigger an asthma event. You can pick up a free report on how to eliminate asthma triggers in your home by using the site link below.
Asthma in children can strike at any age and affects both boys and girls. Children can develop an asthma condition from any age even as little as a few months old. If you have a new little one, be certain to schedule all those well baby checkups. As asthma is a chronic illness, the earlier it can be identified and managed, the less damage it may cause.
Research has indicated that some asthma may also be hereditary in nature. If you or your spouse have asthma, the likelihood that your child may also have the disease increases but is not an absolutely certainty. Remember though that asthma can be successfully treated, managed, and kept under control. Although living with asthma or any persistent condition is not fun, the key is to be prepared, limit exposure to asthma triggers and plan to live a full and rich life with your asthmatic child.
Abigail Franks has done extensive research into Asthma,Allergies, and their triggers. Visit the Asthma site for more information on Childhood Asthma and Asthma Treatments
Asthma and other respiratory conditions are some of the bigger challenges parents can face. The reason is that asthma is a chronic condition that won't go away by simply taking medication. It's a long term illness that demands changes in a families lifestyle and living conditions if the asthmatic child is to live a normal life. While there seems to be severities of asthma, all cases demand special care.
Kids have been known to seemingly "grow out of" childhood asthma. It may be that their bodies have developed a way to overcome many of the triggers and sensitivities, or their respiratory tract has matured. Regardless of the reason, although not an honest cure, anything that results in fewer asthma attacks is a reason to celebrate
Asthma is especially difficult because of it's ongoing chronic nature. Respiratory conditions such as asthma can strike literally at any time and any place. Although very disconcerting to parents, adults can limit the severity and time of an episode by making certain that needed medications are available at the right time.
It's also very possible to lower the number and severity of attacks simply by limiting the exposure to the various things that can trigger an asthma event. You can pick up a free report on how to eliminate asthma triggers in your home by using the site link below.
Asthma in children can strike at any age and affects both boys and girls. Children can develop an asthma condition from any age even as little as a few months old. If you have a new little one, be certain to schedule all those well baby checkups. As asthma is a chronic illness, the earlier it can be identified and managed, the less damage it may cause.
Research has indicated that some asthma may also be hereditary in nature. If you or your spouse have asthma, the likelihood that your child may also have the disease increases but is not an absolutely certainty. Remember though that asthma can be successfully treated, managed, and kept under control. Although living with asthma or any persistent condition is not fun, the key is to be prepared, limit exposure to asthma triggers and plan to live a full and rich life with your asthmatic child.
Abigail Franks has done extensive research into Asthma,Allergies, and their triggers. Visit the Asthma site for more information on Childhood Asthma and Asthma Treatments
Sunday, April 20, 2008
Effective Allergic Asthma Home Remedies Made Simple
Allergic asthma reactions are very real to me as I lost a friend growing up due to a sudden asthma attack. Asthma is a respiratory problem which more often than not is triggered by an allergen. There are other causes, of course however, the most obvious of all causes is allergy, an allergy to dust, to animal dander, to pollen in the air, to humidity, to cold, and so on.
What do you do when you suffer from an asthma attack caused by allergy? You would most likely carry an emergency inhaler which would help you breathe normal in no time, but the best would be to prevent the sudden attack by noticing and avoiding the allergen. In my friend's case this would have helped him survive because he did not have his inhaler with him at the time of the attack. As you can see it is very important to know what you are allergic to if you have asthma.
What About Allergic Asthma Home Remedies?
Since allergic asthma home remedies have been touted to be highly effective, I will describe a few very simple ones below, which are well tried and tested. I hope that you will benefit from these treatments as millions of others across the globe do too.
A change in diet is extremely effective in fighting any type of allergic asthma - try to implement as many of the foods listed below in your diet as possible:
* Soybeans
* Apples
* Lemons
* Oranges
* Figs
* Guava
* Bengal gram (black lentils)
You need these foods to provide you the much needed fiber that prevents constipation, which in turn prevents allergic asthma. Also include whole grains such as barley, maize and oatmeal into your diet. Since we are talking about diet, be informed that Vitamin E is another well known and tested allergic asthma home remedy.
You also need to know that among these remedies, some are very simple, yet they go unnoticed and unknown. For example, just having dinner some two hours before sunset can reduce asthma attacks by 90%.
Among the most famous allergic asthma home remedies is the raisin cure, this is one of the most effective and easy to do allergic asthma home remedies known to mankind. Take about 15-20 raisins and have them soaked in about 150 milliliters of water (a little less than a full glass); in the morning you will find that the raisins have become big, just like grapes. Take these swollen raisins and boil them in a cup (250 ml) of milk. Have this milk at least twice a day.
You will find great relief if you would take a little dry peel of a pomegranate and boil it in the milk along with two raisins and drink it every evening at bed time. For children less than one year old you could use a paste of about five to six leaves of basil and honey instead.
It is important that you avoid all the foods that cause phlegm such as:
* Rice
* Curd
* Lentils
* Banana
You should concentrate instead on eating beneficial foods such as prunes, berries, tomatoes, lettuce, beet root, orange, etc. If you follow the above recommendations and talk to your doctor about what your allergies are you should be able to avoid most future asthma attacks.
If you suffer from asthma you should still always have your inhaler with you anyway, just in case. This is especially important for children, like my friend who don't have a full understanding of asthma and what could trigger an attack.
Anytime you have any medical condition it is always best to fully educate yourself on what it is, what causes it, and how to prevent or deal with it both naturally and medically. That way you will be least affected by the condition and in a position to get rid of it or at least minimize its negative effects on your body.
Brue M. Baker, is an expert on natural health and fitness who has helped people from across the world sky-rocket their health and well-being. Rather than hitting your head against a wall trying to find unbiased health information let Brue take you by the hand and give you the best natural health information and resources on the web. Visit DietHealthAndFitness.com to learn more.
What do you do when you suffer from an asthma attack caused by allergy? You would most likely carry an emergency inhaler which would help you breathe normal in no time, but the best would be to prevent the sudden attack by noticing and avoiding the allergen. In my friend's case this would have helped him survive because he did not have his inhaler with him at the time of the attack. As you can see it is very important to know what you are allergic to if you have asthma.
What About Allergic Asthma Home Remedies?
Since allergic asthma home remedies have been touted to be highly effective, I will describe a few very simple ones below, which are well tried and tested. I hope that you will benefit from these treatments as millions of others across the globe do too.
A change in diet is extremely effective in fighting any type of allergic asthma - try to implement as many of the foods listed below in your diet as possible:
* Soybeans
* Apples
* Lemons
* Oranges
* Figs
* Guava
* Bengal gram (black lentils)
You need these foods to provide you the much needed fiber that prevents constipation, which in turn prevents allergic asthma. Also include whole grains such as barley, maize and oatmeal into your diet. Since we are talking about diet, be informed that Vitamin E is another well known and tested allergic asthma home remedy.
You also need to know that among these remedies, some are very simple, yet they go unnoticed and unknown. For example, just having dinner some two hours before sunset can reduce asthma attacks by 90%.
Among the most famous allergic asthma home remedies is the raisin cure, this is one of the most effective and easy to do allergic asthma home remedies known to mankind. Take about 15-20 raisins and have them soaked in about 150 milliliters of water (a little less than a full glass); in the morning you will find that the raisins have become big, just like grapes. Take these swollen raisins and boil them in a cup (250 ml) of milk. Have this milk at least twice a day.
You will find great relief if you would take a little dry peel of a pomegranate and boil it in the milk along with two raisins and drink it every evening at bed time. For children less than one year old you could use a paste of about five to six leaves of basil and honey instead.
It is important that you avoid all the foods that cause phlegm such as:
* Rice
* Curd
* Lentils
* Banana
You should concentrate instead on eating beneficial foods such as prunes, berries, tomatoes, lettuce, beet root, orange, etc. If you follow the above recommendations and talk to your doctor about what your allergies are you should be able to avoid most future asthma attacks.
If you suffer from asthma you should still always have your inhaler with you anyway, just in case. This is especially important for children, like my friend who don't have a full understanding of asthma and what could trigger an attack.
Anytime you have any medical condition it is always best to fully educate yourself on what it is, what causes it, and how to prevent or deal with it both naturally and medically. That way you will be least affected by the condition and in a position to get rid of it or at least minimize its negative effects on your body.
Brue M. Baker, is an expert on natural health and fitness who has helped people from across the world sky-rocket their health and well-being. Rather than hitting your head against a wall trying to find unbiased health information let Brue take you by the hand and give you the best natural health information and resources on the web. Visit DietHealthAndFitness.com to learn more.
Saturday, April 19, 2008
The Deep World of Asthma
The asthma is caused by airway hyper responsiveness to various stimuli such as a virus, allergen and exercise. The asthma affected 17.3 million individuals in the United States and 150 million worldwide. It is more seen in the children's.
This is not curable but the symptoms of the asthma can be reduces. So this is life long disease. Asthma occurs in persons of all races worldwide. The asthma appearance ratio is from male to female is 1:1. The asthma is appeared in the age of 18 years but the effect of asthma is seen in the adult age. The cause of asthma is usually due to the airway wall inflammation and airway wall constriction which arises due to the release inflammatory response chemical signals.
Causes of asthma
Dust
Exercise
Viral upper respiratory infection
Pollen
Genetic
Stress
Environmental changes
Symptoms of asthma
Wheezing
Sputum production
Allergens
Breathlessness
Decreased endurance
Chest tightness
Treatment of asthma
The immunoglobulin E may be decreases the bronchial airflow.
The T-lymphocytes may be used to release of an inflammatory mediators from eosinophils, mast cells, and lymphocytes.
Maintain pulmonary function as close to normal levels.
The T-helper 2 subset produces cytokines which stimulate the growth and the allergic response.
The inhaled corticosteroids are used for the management of asthma.
By using allergy skin test we can reduce the asthma.
Rachel Broune writes articles for Asthma home remedies. He also writes for Asthma causes and cure and Asthma complete information.
This is not curable but the symptoms of the asthma can be reduces. So this is life long disease. Asthma occurs in persons of all races worldwide. The asthma appearance ratio is from male to female is 1:1. The asthma is appeared in the age of 18 years but the effect of asthma is seen in the adult age. The cause of asthma is usually due to the airway wall inflammation and airway wall constriction which arises due to the release inflammatory response chemical signals.
Causes of asthma
Dust
Exercise
Viral upper respiratory infection
Pollen
Genetic
Stress
Environmental changes
Symptoms of asthma
Wheezing
Sputum production
Allergens
Breathlessness
Decreased endurance
Chest tightness
Treatment of asthma
The immunoglobulin E may be decreases the bronchial airflow.
The T-lymphocytes may be used to release of an inflammatory mediators from eosinophils, mast cells, and lymphocytes.
Maintain pulmonary function as close to normal levels.
The T-helper 2 subset produces cytokines which stimulate the growth and the allergic response.
The inhaled corticosteroids are used for the management of asthma.
By using allergy skin test we can reduce the asthma.
Rachel Broune writes articles for Asthma home remedies. He also writes for Asthma causes and cure and Asthma complete information.
Thursday, April 17, 2008
How To Identify An Allergic Asthma?
An allergic asthma. It is a chronic inflammatory disorder of the lung airways. It's symptoms are made worse by exposure to an allergen (e.g., dust, mold, pollen, dust mite allergens and animal dander) to which the patient has been sensitized.
A simple sneeze could trigger allergic asthma or a simple cough could lead to that as well.
What are the symptoms of allergic asthma?
The symptoms of allergic and non-allergic asthma are the same. They include coughing, wheezing, shortness of breath or rapid breathing, and chest tightness. These symptoms are often provoked by an identifiable trigger.
What factors can cause or trigger allergic asthma?
A family history of allergies is the most important predictor of whether a person will develop asthma. Environmental substances (allergens) can trigger an exacerbation - or attack - in patients with allergic asthma.
The allergens include tree, grass, and weed pollen, plus molds, animal dander, dust mites and cockroach droppings. Asthma attacks can also be triggered by viral infections, exercise, cold air and non-specific irritants.
How many people suffer from allergic asthma?
Allergic asthma is the most common form of asthma. According to the National Institute of Environmental Health Sciences, of the 17 million asthma sufferers in the United States, 10 million (approximately 60 percent) have allergic asthma. Three million are children and 7 million are adults.
What is the relationship between allergies and allergic asthma?
Most people with asthma also suffer from other allergic disorders. In fact, research from the World Health Organization (WHO) shows that at least 70 percent of asthmatics also suffer from allergic rhinitis or "hay fever."
Nasal allergies and allergic asthma are both triggered by exposure to allergens, initiating a series of events that result in tightening of the airways, swelling of the lining of the airways, nose and eyes, and mucus production.
What is IgE and why is it important in allergic asthma?
IgE (Immunoglobulin E) is an antibody in the human immune system that plays a critical role in the allergic process.
When an individual is sensitized to an allergen, he or she produces an IgE antibody directed against that allergen. The IgE antibody attaches to mast cells.
When the individual is exposed to that same allergen again, the allergen binds to the IgE on the mast cell causing it to release substances such as histamine, prostaglandins and leukotrienes, which cause symptoms such as chest tightness, coughing and wheezing.
What treatments are available for people suffering from allergic asthma?
It is important for people with asthma to seek treatment. First, patients are evaluated to identify their specific allergic triggers and a program of allergen avoidance is recommended.
Asthma is treated with medications including anti-inflammatory agents, such as corticosteroids and anti-leukotrienes that decrease inflammation in the lungs, and bronchodilators used for relief of symptoms.
Allergen immunotherapy, also known as allergy shots, is a program of injections that reduces allergic sensitization.
A new drug currently under review by the Food and Drug Administration (FDA), known as anti-IgE, concentrates on short-circuiting the allergic reaction in the body before it even begins.
Anti-IgE therapy stops the allergic reaction before it starts, allowing the patient to avoid allergy symptoms that often trigger an asthma attack or lead to the development of asthma attacks.
Researchers are looking for targets for new forms of treatment. Future therapies may focus on cytokines, substances that maintain the chronic inflammation responsible for asthma.
Other research may also lead to the development of new anti-inflammatory drugs, which may retain the anti-inflammatory effects of corticosteroids but cause fewer systemic side effects.
As the more and more developing countries are emerging, more and more air pollution is arising, whether asthma or allergic asthma, the number of people having is rising.
They could have acquired this chronic illness rather than having it genetically as the environment is getting more and more dirtier.
Eddy Elton is the owner of website, UniqueAsthmaTreatmentSecrets.com. You can subscribe to a free report by visiting his web site at Allergic Asthma and receive updates when the latest to be released on asthma treatment is available.
A simple sneeze could trigger allergic asthma or a simple cough could lead to that as well.
What are the symptoms of allergic asthma?
The symptoms of allergic and non-allergic asthma are the same. They include coughing, wheezing, shortness of breath or rapid breathing, and chest tightness. These symptoms are often provoked by an identifiable trigger.
What factors can cause or trigger allergic asthma?
A family history of allergies is the most important predictor of whether a person will develop asthma. Environmental substances (allergens) can trigger an exacerbation - or attack - in patients with allergic asthma.
The allergens include tree, grass, and weed pollen, plus molds, animal dander, dust mites and cockroach droppings. Asthma attacks can also be triggered by viral infections, exercise, cold air and non-specific irritants.
How many people suffer from allergic asthma?
Allergic asthma is the most common form of asthma. According to the National Institute of Environmental Health Sciences, of the 17 million asthma sufferers in the United States, 10 million (approximately 60 percent) have allergic asthma. Three million are children and 7 million are adults.
What is the relationship between allergies and allergic asthma?
Most people with asthma also suffer from other allergic disorders. In fact, research from the World Health Organization (WHO) shows that at least 70 percent of asthmatics also suffer from allergic rhinitis or "hay fever."
Nasal allergies and allergic asthma are both triggered by exposure to allergens, initiating a series of events that result in tightening of the airways, swelling of the lining of the airways, nose and eyes, and mucus production.
What is IgE and why is it important in allergic asthma?
IgE (Immunoglobulin E) is an antibody in the human immune system that plays a critical role in the allergic process.
When an individual is sensitized to an allergen, he or she produces an IgE antibody directed against that allergen. The IgE antibody attaches to mast cells.
When the individual is exposed to that same allergen again, the allergen binds to the IgE on the mast cell causing it to release substances such as histamine, prostaglandins and leukotrienes, which cause symptoms such as chest tightness, coughing and wheezing.
What treatments are available for people suffering from allergic asthma?
It is important for people with asthma to seek treatment. First, patients are evaluated to identify their specific allergic triggers and a program of allergen avoidance is recommended.
Asthma is treated with medications including anti-inflammatory agents, such as corticosteroids and anti-leukotrienes that decrease inflammation in the lungs, and bronchodilators used for relief of symptoms.
Allergen immunotherapy, also known as allergy shots, is a program of injections that reduces allergic sensitization.
A new drug currently under review by the Food and Drug Administration (FDA), known as anti-IgE, concentrates on short-circuiting the allergic reaction in the body before it even begins.
Anti-IgE therapy stops the allergic reaction before it starts, allowing the patient to avoid allergy symptoms that often trigger an asthma attack or lead to the development of asthma attacks.
Researchers are looking for targets for new forms of treatment. Future therapies may focus on cytokines, substances that maintain the chronic inflammation responsible for asthma.
Other research may also lead to the development of new anti-inflammatory drugs, which may retain the anti-inflammatory effects of corticosteroids but cause fewer systemic side effects.
As the more and more developing countries are emerging, more and more air pollution is arising, whether asthma or allergic asthma, the number of people having is rising.
They could have acquired this chronic illness rather than having it genetically as the environment is getting more and more dirtier.
Eddy Elton is the owner of website, UniqueAsthmaTreatmentSecrets.com. You can subscribe to a free report by visiting his web site at Allergic Asthma and receive updates when the latest to be released on asthma treatment is available.
Wednesday, April 16, 2008
Asthma Air Purifier: An Essential Tool to Reduce Attacks in Your Home
Asthma is a prevalent modern disease that appears to be on the rise. The causes are not entirely known, but many asthmatics and parents of asthmatic children have learned some of the triggers that lead to an attack. A good asthma air purifier in the home can help reduce the level of these triggers, and thus help prevent further asthma attacks.
Asthma is a kind of allergic response in which the airways in the lungs become irritated and swell up, restricting airflow. It can be a very frightening experience, when getting a breath of air feels nearly impossible. Young children in particular can be traumatized by asthma attacks, because it is difficult to get them to calm down when the reaction is occurring, and calm is important in mitigating the seriousness of the attack. Unfortunately, asthma is becoming more and more common in our industrialized world.
Although we tend to think of our households as being safer than outside our doors, in the case of air quality indoor air can often be worse, even in urban centres. This is because not only is the air inside essentially the same as outside, there are often trapped components that help create an unhealthy atmosphere. Some of the most common triggers for asthma attacks are house dust, mold spores, pollen, and pet dander.
Another category which is known to trigger asthma is volatile organic compounds, or VOC's. These are a by-product of the manufacturing process of much of our household products, including carpet, furniture, paint, lacquers, all kinds of plastics, and cleaning supplies. Sensitivity to VOC's varies, but many people experience symptoms without being aware of what the cause is.
The good news for asthmatics is that controlling many of these triggers is easily possible with a good home air purifier. Because most of the triggers can be categorized as particulates, these can be filtered out of the air flow using a good HEPA filter. HEPA filters are capable of filtering particles as small as 0.3 microns, meaning it can even catch bacteria, which are generally 0.2 to 20 microns in size. A good asthma air purifier should have a pre-filter which catches larger dust and hair first, then passes the air through a second filter to grab the most minute particles.
It is important that the filters be changed regularly, as the filters will clog up and the amount of air that can then be passed through the filter will drop. Replacement of the filters will depend on the unit, its amount of usage, and of course the condition of the air that it is filtering. Be sure to monitor the filter, especially when first using the unit, to get an idea how often it should be changed. Many units come with a filter alert system, that reminds you when it is time to change the filter.
Unfortunately when it comes to VOC's it is much more difficult to remove them from the air due to their often minute size. The good news is that VOC 'off-gassing' or 'out-gassing' as it is known, usually only occurs for a short period of time, when a product is new. The passage of time and regular exchanges of air (with an open window, for instance) can often reduce the problem considerably.
There is a new kind of system on the market called photocatalytic air purifier which uses a sophisticated ultraviolet method to create free radicals which actually breakdown VOC's completely. The manufacturer claims for these units are outstanding, however, even with this kind of system in place, for the asthmatic it is still important to remove irritating particles from the air as well.
The home should be a sanctuary, but unfortunately much of our modern lifestyle comes at a price. The sharp rise in asthma-sufferers is testament to this. But at least with an asthma air purifier in place, we can make our homes healthy and comfortable for all.
To find out more about the asthma air purifier and other home air purifiers, please visit: http://www.HealthyHomeFacts.com
Brent Craig has a dedicated interest in healthy homes and environmentally friendly lifestyles. He lives in Toronto.
Asthma is a kind of allergic response in which the airways in the lungs become irritated and swell up, restricting airflow. It can be a very frightening experience, when getting a breath of air feels nearly impossible. Young children in particular can be traumatized by asthma attacks, because it is difficult to get them to calm down when the reaction is occurring, and calm is important in mitigating the seriousness of the attack. Unfortunately, asthma is becoming more and more common in our industrialized world.
Although we tend to think of our households as being safer than outside our doors, in the case of air quality indoor air can often be worse, even in urban centres. This is because not only is the air inside essentially the same as outside, there are often trapped components that help create an unhealthy atmosphere. Some of the most common triggers for asthma attacks are house dust, mold spores, pollen, and pet dander.
Another category which is known to trigger asthma is volatile organic compounds, or VOC's. These are a by-product of the manufacturing process of much of our household products, including carpet, furniture, paint, lacquers, all kinds of plastics, and cleaning supplies. Sensitivity to VOC's varies, but many people experience symptoms without being aware of what the cause is.
The good news for asthmatics is that controlling many of these triggers is easily possible with a good home air purifier. Because most of the triggers can be categorized as particulates, these can be filtered out of the air flow using a good HEPA filter. HEPA filters are capable of filtering particles as small as 0.3 microns, meaning it can even catch bacteria, which are generally 0.2 to 20 microns in size. A good asthma air purifier should have a pre-filter which catches larger dust and hair first, then passes the air through a second filter to grab the most minute particles.
It is important that the filters be changed regularly, as the filters will clog up and the amount of air that can then be passed through the filter will drop. Replacement of the filters will depend on the unit, its amount of usage, and of course the condition of the air that it is filtering. Be sure to monitor the filter, especially when first using the unit, to get an idea how often it should be changed. Many units come with a filter alert system, that reminds you when it is time to change the filter.
Unfortunately when it comes to VOC's it is much more difficult to remove them from the air due to their often minute size. The good news is that VOC 'off-gassing' or 'out-gassing' as it is known, usually only occurs for a short period of time, when a product is new. The passage of time and regular exchanges of air (with an open window, for instance) can often reduce the problem considerably.
There is a new kind of system on the market called photocatalytic air purifier which uses a sophisticated ultraviolet method to create free radicals which actually breakdown VOC's completely. The manufacturer claims for these units are outstanding, however, even with this kind of system in place, for the asthmatic it is still important to remove irritating particles from the air as well.
The home should be a sanctuary, but unfortunately much of our modern lifestyle comes at a price. The sharp rise in asthma-sufferers is testament to this. But at least with an asthma air purifier in place, we can make our homes healthy and comfortable for all.
To find out more about the asthma air purifier and other home air purifiers, please visit: http://www.HealthyHomeFacts.com
Brent Craig has a dedicated interest in healthy homes and environmentally friendly lifestyles. He lives in Toronto.
WFP Resumes Programs Providing Food To People With TB, HIV In Cambodia After Receiving Aid From Spain, U.S.
The World Food Program has resumed its programs providing people living with HIV and tuberculosis in Cambodia with access to food after receiving aid from Spain and the U.S., the agency said on Thursday, the AP/International Herald Tribune reports (AP/International Herald Tribune, 2/8). Thomas Keusters, country director for WFP's Cambodia office, said recently that WFP had been "forced to suspend" the programs because of funding shortages. The programs distribute food rations to 18,000 people with TB and 70,000 people with HIV. They also ensure that HIV-positive people and people with TB needing medicine are connected with food distribution points. "The sick need food first before taking medicines," Haidy Ear-Dupuy -- advocacy manager at the Phnom Penh, Cambodia, office of World Vision -- said, adding, "You cannot take medication on an empty stomach. You must maintain a balance" (Macan-Markar, Inter Press Service, 2/6). WFP in a statement on Thursday said that Spain has provided about $650,000 and that the U.S. has provided 6,100 tons of legumes, as well as 2,370 tons of vegetable oil, for a period of three years. WFP three weeks ago announced that it needed at least $10 million to run its programs in Cambodia through July (AP/International Herald Tribune, 2/8). Keusters said WFP welcomed the donations but added that more "urgent donations" are needed (Agence France-Presse, 2/8). HIV prevalence in Cambodia is 1.6%, the highest in Southeast Asia, according to Inter Press Service (Inter Press Service, 2/6).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Slow-Release Morphine Reduces Level Of Intractable Cough
Slow-release morphine helped a group of patients with long-term, treatment-resistant chronic cough reduce their daily cough score levels by 40 percent.
The research results appear in the second issue for February 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
Alyn H. Morice, M.D., of the Department of Academic Medicine at the University of Hull and Castle Hill Hospital in East Yorkshire, United Kingdom, and six associates enrolled 27 patients with intractable cough in an eight-week, randomized, double-blind, placebo-controlled study to test the use of slow-release morphine sulfate versus a placebo on their cough. Each phase lasted four weeks.
Morphine, derived from opium, is used in medicine as an analgesic, light anesthetic or a sedative. Although opiates have been long advocated for the suppression of cough, there are few trial data to support this recommendation. In fact, prior to this research, the use of opiates in intractable chronic cough had never been studied.
"Although acute cough is benign and self-limiting, chronic persistent cough can have a devastating effect on the quality of life of sufferers," said Dr. Morice. "This research provides evidence for the use of opiates in chronic cough."
The investigators found a "rapid and highly significant reduction by 40 percent in daily cough scores was noted by patients on slow-release morphine sulfate."
Patients responded quickly to treatment starting at five milligrams twice daily. The researchers found patients benefited the most by day five of treatment, and that this response was sustained through the remainder of the four-week period. The authors noted that the rapid response to morphine was in contrast to the absence of any effect of placebo.
The 27 participants, 18 of whom were female, were recruited from a hospital cough clinic. All had endured a chronic, persistent cough for more than three months. Their average age was 55.
During each four-week interval, patients made three visits to a clinical trial center, where they filled out a quality-of-life questionnaire on the impact of chronic cough on activities of daily living. A spirometric lung test was performed at the first visit, and lung function was measured on each subsequent visit.
In addition, each participant assessed their cough severity daily, rating it from 0 to 9 on a record card. Participants could not use other cough remedies, including over-the-counter products, during the eight-week study period.
According to the authors, one-third of the participants increased their dose of morphine sulfate from 5 mg to 10 mg twice daily during the first month; 11 percent did so in the second month; and a further 22 percent joined them in the third month. By the end of the study, two-thirds of the patients had increased their dose to 10 milligrams.
"The optimum dose in the suppression of chronic cough lies between 5 and 10 mg twice daily," said Dr. Morice, who added that the most common side effects were constipation (40 percent) and drowsiness (25 percent).
The investigators believe that the risk-benefit ratio makes low-dose morphine sulfate a credible therapeutic option for patients with chronic cough who fail other specific treatments.
Founded in 1905, the American Thoracic Society is the world's leading medical association dedicated to advancing pulmonary, critical care and sleep medicine. The Society has more than 18,000 members who prevent and fight respiratory disease around the globe, through research, education, patient care and advocacy.
American Thoracic Society
61 Broadway, 4th Floor
New York, NY 10006-2755
http://www.thoracic.org
See you at ATS 2008-the 103rd International Conference, May 18-23 San Francisco, CA
The research results appear in the second issue for February 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
Alyn H. Morice, M.D., of the Department of Academic Medicine at the University of Hull and Castle Hill Hospital in East Yorkshire, United Kingdom, and six associates enrolled 27 patients with intractable cough in an eight-week, randomized, double-blind, placebo-controlled study to test the use of slow-release morphine sulfate versus a placebo on their cough. Each phase lasted four weeks.
Morphine, derived from opium, is used in medicine as an analgesic, light anesthetic or a sedative. Although opiates have been long advocated for the suppression of cough, there are few trial data to support this recommendation. In fact, prior to this research, the use of opiates in intractable chronic cough had never been studied.
"Although acute cough is benign and self-limiting, chronic persistent cough can have a devastating effect on the quality of life of sufferers," said Dr. Morice. "This research provides evidence for the use of opiates in chronic cough."
The investigators found a "rapid and highly significant reduction by 40 percent in daily cough scores was noted by patients on slow-release morphine sulfate."
Patients responded quickly to treatment starting at five milligrams twice daily. The researchers found patients benefited the most by day five of treatment, and that this response was sustained through the remainder of the four-week period. The authors noted that the rapid response to morphine was in contrast to the absence of any effect of placebo.
The 27 participants, 18 of whom were female, were recruited from a hospital cough clinic. All had endured a chronic, persistent cough for more than three months. Their average age was 55.
During each four-week interval, patients made three visits to a clinical trial center, where they filled out a quality-of-life questionnaire on the impact of chronic cough on activities of daily living. A spirometric lung test was performed at the first visit, and lung function was measured on each subsequent visit.
In addition, each participant assessed their cough severity daily, rating it from 0 to 9 on a record card. Participants could not use other cough remedies, including over-the-counter products, during the eight-week study period.
According to the authors, one-third of the participants increased their dose of morphine sulfate from 5 mg to 10 mg twice daily during the first month; 11 percent did so in the second month; and a further 22 percent joined them in the third month. By the end of the study, two-thirds of the patients had increased their dose to 10 milligrams.
"The optimum dose in the suppression of chronic cough lies between 5 and 10 mg twice daily," said Dr. Morice, who added that the most common side effects were constipation (40 percent) and drowsiness (25 percent).
The investigators believe that the risk-benefit ratio makes low-dose morphine sulfate a credible therapeutic option for patients with chronic cough who fail other specific treatments.
Founded in 1905, the American Thoracic Society is the world's leading medical association dedicated to advancing pulmonary, critical care and sleep medicine. The Society has more than 18,000 members who prevent and fight respiratory disease around the globe, through research, education, patient care and advocacy.
American Thoracic Society
61 Broadway, 4th Floor
New York, NY 10006-2755
http://www.thoracic.org
See you at ATS 2008-the 103rd International Conference, May 18-23 San Francisco, CA
Drug Reduces Unscheduled Trips To Doctor For Childhood Asthma Attacks
Young children with attacks of sporadic, recurring asthma who were treated with the prescription drug montelukast by their parents had fewer unscheduled trips to the doctor, missed less days from school or childcare, and caused their parents to take fewer days off work for their care.
Results from this multi-center, randomized, double-blind and placebo-controlled trial appear in the second issue for February 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
Colin F. Robertson, M.D., of the Department of Respiratory Medicine at Royal Children's Hospital in Melbourne, Australia, and eight associates studied 202 children, ages 2 to 14, who were given either montelukast or placebo by their parents when needed for one year. All of the children had intermittent, doctor-diagnosed asthma.
By the end of the year-long study, the patients treated with montelukast had 163 unscheduled health resource visits for their illness, as compared with 228 in the placebo group.
"Symptoms were reduced by 14 percent, nights awakened by 8.6 percent, days off from school or childcare by 37 percent and parent time off from work by 33 percent," said Dr. Robertson.
In asthma, children's airways become chronically inflamed, with various stimuli causing episodes of airway obstruction and breathing difficulties. The disease is the most common chronic disorder of childhood and affects an estimated 6.2 million children under age 18 in the U.S.
Intermittent asthma is the most common pattern of the disease in children, accounting for attacks in 75 percent of affected youngsters.
Montelukast sodium, a specific leukotriene receptor antagonist that has been shown to be effective in children, is used to prevent mild, persistent asthma. It reduces the swelling and inflammation that tend to close airways, and relaxes the walls of the bronchial tubes, allowing more air to pass through to the lungs.
"Acute episodes of asthma in young children place a significant burden on healthcare resources," said Dr. Robertson. "Admission to the hospital for asthma in children aged 0 to 4 years is five times more common, and for those aged 5 to 14 years, twice as common as for adults who have asthma."
The study was designed to evaluate parent-initiated therapy with montelukast at the onset of each upper respiratory infection or asthma symptom. Treatment continued for a minimum of seven days or until symptoms had resolved for 24 hours.
"A key component of the study was the impact of asthma on the family, as measured by days absent from school or childcare, nights of disturbed sleep, and the number of parent days lost from work," said Dr. Robertson. "Furthermore, the strategy of parent-initiated therapy required children on average to take the study drug only 30 days per year, rather than 365, providing a further cost-benefit for the family."
The authors noted that there was no significant reduction in specialist care, hospitalizations, duration of episodes, or use of beta-agonists and prednisolone as a result of montelukast study.
An analysis of cost showed that the use of montelukast resulted in a savings of $124 Australian dollars - about $96 U.S. dollars - or 29 percent less per treated episode than the placebo controlled arm of the trial.
Founded in 1905, the American Thoracic Society is the world's leading medical association dedicated to advancing pulmonary, critical care and sleep medicine. The Society has more than 18,000 members who prevent and fight respiratory disease around the globe, through research, education, patient care and advocacy.
American Thoracic Society
61 Broadway, 4th Floor
New York, NY 10006-2755
http://www.thoracic.org
See you at ATS 2008-the 103rd International Conference, May 18-23 San Francisco, CA
Results from this multi-center, randomized, double-blind and placebo-controlled trial appear in the second issue for February 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
Colin F. Robertson, M.D., of the Department of Respiratory Medicine at Royal Children's Hospital in Melbourne, Australia, and eight associates studied 202 children, ages 2 to 14, who were given either montelukast or placebo by their parents when needed for one year. All of the children had intermittent, doctor-diagnosed asthma.
By the end of the year-long study, the patients treated with montelukast had 163 unscheduled health resource visits for their illness, as compared with 228 in the placebo group.
"Symptoms were reduced by 14 percent, nights awakened by 8.6 percent, days off from school or childcare by 37 percent and parent time off from work by 33 percent," said Dr. Robertson.
In asthma, children's airways become chronically inflamed, with various stimuli causing episodes of airway obstruction and breathing difficulties. The disease is the most common chronic disorder of childhood and affects an estimated 6.2 million children under age 18 in the U.S.
Intermittent asthma is the most common pattern of the disease in children, accounting for attacks in 75 percent of affected youngsters.
Montelukast sodium, a specific leukotriene receptor antagonist that has been shown to be effective in children, is used to prevent mild, persistent asthma. It reduces the swelling and inflammation that tend to close airways, and relaxes the walls of the bronchial tubes, allowing more air to pass through to the lungs.
"Acute episodes of asthma in young children place a significant burden on healthcare resources," said Dr. Robertson. "Admission to the hospital for asthma in children aged 0 to 4 years is five times more common, and for those aged 5 to 14 years, twice as common as for adults who have asthma."
The study was designed to evaluate parent-initiated therapy with montelukast at the onset of each upper respiratory infection or asthma symptom. Treatment continued for a minimum of seven days or until symptoms had resolved for 24 hours.
"A key component of the study was the impact of asthma on the family, as measured by days absent from school or childcare, nights of disturbed sleep, and the number of parent days lost from work," said Dr. Robertson. "Furthermore, the strategy of parent-initiated therapy required children on average to take the study drug only 30 days per year, rather than 365, providing a further cost-benefit for the family."
The authors noted that there was no significant reduction in specialist care, hospitalizations, duration of episodes, or use of beta-agonists and prednisolone as a result of montelukast study.
An analysis of cost showed that the use of montelukast resulted in a savings of $124 Australian dollars - about $96 U.S. dollars - or 29 percent less per treated episode than the placebo controlled arm of the trial.
Founded in 1905, the American Thoracic Society is the world's leading medical association dedicated to advancing pulmonary, critical care and sleep medicine. The Society has more than 18,000 members who prevent and fight respiratory disease around the globe, through research, education, patient care and advocacy.
American Thoracic Society
61 Broadway, 4th Floor
New York, NY 10006-2755
http://www.thoracic.org
See you at ATS 2008-the 103rd International Conference, May 18-23 San Francisco, CA
Animal Testing Reduced By Soft-Cell Approach
The new in-vitro technique pioneered by Dr Amanda Hayes and her UNSW colleagues, Shahnaz Bakand and Chris Winder, directly exposes human cells to airborne toxicants and measures cytotoxic effects. The cells are grown on a porous polyester membrane inside a small diffusion chamber and then exposed to selected toxic air pollutants. After as little as one hour's exposure, they can study cell growth and metabolism, and a range of routine toxicological endpoints.
Importantly, the toxic measurements obtained by the in vitro method, such as the amount of a contaminant needed to inhibit cell growth, mirror well-established lethal values obtained from animal studies - a long-established method in toxicological studies. "In-vitro toxicity tests can improve the scientific, economic, and ethical value of research and play a significant role in the screening of toxic chemicals and the replacement of animals," Dr Hayes says.
This research earned Hayes and her colleagues the 2006 Australian Museum Voiceless Eureka Prize for Research. This prize rewards scientists for work that has reduced the use of animals or animal products in laboratory-based research, education and testing.
Many industrial and environmental air pollutants are already known to have adverse health effects on the respiratory system of workers. Increasingly, new formulations are using tiny nanoparticles and ultrafine particulates in cosmetics, pharmaceuticals and petrochemical products. Little is known about their toxicity and safety to human health but this new category of pollutants poses possible dangers, both medically and environmentally, especially if they get airborne.
Most nanoparticles have a high surface area-to-mass ratio that can make the particles very reactive or catalytic. Being so small, they may also be able to pass through cell walls in organisms, and their reactions inside the body are relatively unknown.
"These tiny new substances are the tip of a huge chemical iceberg," says Hayes, Manager of the Chemical Safety and Applied Toxicology Laboratories at the University of New South Wales.
"Worldwide, there are millions of known chemicals, of which more than 100,000 chemical compounds are in commercial use in an unknown but extremely large number of chemical mixtures.
"Continued conventional animal toxicity testing of this large number of chemicals is simply unachievable from a scientific and economic standpoint," says Dr Hayes. "It's also unethical, given that in Australia alone, more than a million dogs, cats, rabbits, sheep, cattle, pigs and mice are used each year for toxicological testing and research." This is a drop in the ocean, compared with the animal death toll in the rest of the world.
In many inhalation studies, the toxicity of airborne chemicals is tested on laboratory animals by placing them in enclosed chambers and subjecting them to increasing concentrations of the test compounds for specified times until half of the test animals are killed. One type of test commonly used where this occurs is the LD50 test, where LD stands for lethal dose.
This heavy reliance on animal data in toxicology has long been a concern of the scientific community. Predicting the biological activities of toxic chemicals in humans by using animal data always poses uncertainty due to differences between animals and humans.
In a series of published experiments, the UNSW team has demonstrated the feasibility of their in vitro technique for:
* formaldehyde, an industrial contaminant linked to human cancer;
* nitrogen dioxide, a lung irritant that causes inflammation, pulmonary oedema, and pneumonia;
* fire combustion products, including cyanide, hydrogen sulphide, and ammonia; and,
* the volatile organic compounds (VOCs) xylene and toluene, found in solvents used by the printing, painting, and petrochemical industries.
The in vitro method "opens new possibilities for toxicity testing of industrial chemicals, environmental contaminants, workplace airborne contaminants, and fire combustion products", says Dr Hayes.
The technique has several advantages over conventional tests:
* The use of human cells (as opposed to animal cells) generates data representative of direct human chemical exposure.
* A number of human cell types such as lung, skin and liver can be used to represent target organs that are more likely to be significantly exposed or affected by air pollutants. As the respiratory system is both a site of toxicity for pulmonary toxicants, and a pathway for inhaled chemicals to reach other organs, relevant airway cells and lung cells are a major focus for inhalation studies.
* The advantage of using human cell lines and cultures is that the researcher can study toxicity mechanisms at the molecular/cellular level at an earlier stage specifically for individual chemicals, depending on their site of action within the human body without using animals. For example, when assessing the toxicity of formaldehyde, which is known to have a toxic effect on the liver, liver type cells such as hepatocytes can be chosen.
* The in vitro technique is cheap and portable, so scientists can measure immediate toxicity events, rather than waiting for toxicity to be expressed as organ or organism failure many months or even years down the track from initial exposure.
* The application of in vitro methods could open new possibilities for toxicity testing of industrial chemicals, occupational and environmental contaminants, combustion products and respiratory therapeutics and lead to a better understanding of the interactions between chemical exposure and toxic effects of single chemicals and chemical mixtures.
###
Contact: Dr Amanda Hayes
University of New South Wales
Importantly, the toxic measurements obtained by the in vitro method, such as the amount of a contaminant needed to inhibit cell growth, mirror well-established lethal values obtained from animal studies - a long-established method in toxicological studies. "In-vitro toxicity tests can improve the scientific, economic, and ethical value of research and play a significant role in the screening of toxic chemicals and the replacement of animals," Dr Hayes says.
This research earned Hayes and her colleagues the 2006 Australian Museum Voiceless Eureka Prize for Research. This prize rewards scientists for work that has reduced the use of animals or animal products in laboratory-based research, education and testing.
Many industrial and environmental air pollutants are already known to have adverse health effects on the respiratory system of workers. Increasingly, new formulations are using tiny nanoparticles and ultrafine particulates in cosmetics, pharmaceuticals and petrochemical products. Little is known about their toxicity and safety to human health but this new category of pollutants poses possible dangers, both medically and environmentally, especially if they get airborne.
Most nanoparticles have a high surface area-to-mass ratio that can make the particles very reactive or catalytic. Being so small, they may also be able to pass through cell walls in organisms, and their reactions inside the body are relatively unknown.
"These tiny new substances are the tip of a huge chemical iceberg," says Hayes, Manager of the Chemical Safety and Applied Toxicology Laboratories at the University of New South Wales.
"Worldwide, there are millions of known chemicals, of which more than 100,000 chemical compounds are in commercial use in an unknown but extremely large number of chemical mixtures.
"Continued conventional animal toxicity testing of this large number of chemicals is simply unachievable from a scientific and economic standpoint," says Dr Hayes. "It's also unethical, given that in Australia alone, more than a million dogs, cats, rabbits, sheep, cattle, pigs and mice are used each year for toxicological testing and research." This is a drop in the ocean, compared with the animal death toll in the rest of the world.
In many inhalation studies, the toxicity of airborne chemicals is tested on laboratory animals by placing them in enclosed chambers and subjecting them to increasing concentrations of the test compounds for specified times until half of the test animals are killed. One type of test commonly used where this occurs is the LD50 test, where LD stands for lethal dose.
This heavy reliance on animal data in toxicology has long been a concern of the scientific community. Predicting the biological activities of toxic chemicals in humans by using animal data always poses uncertainty due to differences between animals and humans.
In a series of published experiments, the UNSW team has demonstrated the feasibility of their in vitro technique for:
* formaldehyde, an industrial contaminant linked to human cancer;
* nitrogen dioxide, a lung irritant that causes inflammation, pulmonary oedema, and pneumonia;
* fire combustion products, including cyanide, hydrogen sulphide, and ammonia; and,
* the volatile organic compounds (VOCs) xylene and toluene, found in solvents used by the printing, painting, and petrochemical industries.
The in vitro method "opens new possibilities for toxicity testing of industrial chemicals, environmental contaminants, workplace airborne contaminants, and fire combustion products", says Dr Hayes.
The technique has several advantages over conventional tests:
* The use of human cells (as opposed to animal cells) generates data representative of direct human chemical exposure.
* A number of human cell types such as lung, skin and liver can be used to represent target organs that are more likely to be significantly exposed or affected by air pollutants. As the respiratory system is both a site of toxicity for pulmonary toxicants, and a pathway for inhaled chemicals to reach other organs, relevant airway cells and lung cells are a major focus for inhalation studies.
* The advantage of using human cell lines and cultures is that the researcher can study toxicity mechanisms at the molecular/cellular level at an earlier stage specifically for individual chemicals, depending on their site of action within the human body without using animals. For example, when assessing the toxicity of formaldehyde, which is known to have a toxic effect on the liver, liver type cells such as hepatocytes can be chosen.
* The in vitro technique is cheap and portable, so scientists can measure immediate toxicity events, rather than waiting for toxicity to be expressed as organ or organism failure many months or even years down the track from initial exposure.
* The application of in vitro methods could open new possibilities for toxicity testing of industrial chemicals, occupational and environmental contaminants, combustion products and respiratory therapeutics and lead to a better understanding of the interactions between chemical exposure and toxic effects of single chemicals and chemical mixtures.
###
Contact: Dr Amanda Hayes
University of New South Wales
Medicsight Plc Receives Canadian Medical Device Licenses For ColonCAD API And LungCAD API
MGT Capital Investments, Inc. (Amex: MGT), an investment company focused on the health care information technology sector, announced today that its subsidiary, Medicsight plc, was granted medical device licenses from the Therapeutic Products Directorate (TPD) of Health Canada to begin marketing and selling Medicsight ColonCAD API and Medicsight LungCAD API.
David Sumner, chief executive officer of Medicsight plc, commented, "We are extremely pleased to receive Canadian medical device licenses for our colon and lung CAD products. These approvals build on Medicsight's recent ColonCAR(TM) market release in the United States and Europe and expands the addressable market of our CAD products for the Company and its distribution partners."
Mr. Sumner continued, "Medicsight's ColonCAD addresses many of the difficulties faced by radiologists and has been designed to help unlock the full potential of virtual colonoscopy. Our LungCAD is designed to allow radiologists to detect and segment lung nodules at early stage, enhancing treatment options and disease management. For these reasons we believe that our products will be well received by the Canadian market and we will continue to work diligently to bring this important software to radiologists around the globe."
Medicsight's CAD products are designed to be seamlessly integrated into either 3D workstations or Picture Archiving Systems (PACS) and assist radiologists in the identification of potentially fatal lesions found in the lung and polyps found in the colon. Medicsight's CAD products are designed to improve radiologist workflow and productivity.
Medicsight ColonCAD API is an image-analysis software tool designed to be used with CT (computed tomography) colonography (virtual colonoscopy) to assist radiologists in detecting and measuring potential colorectal polyps. ColonCAD has been developed using one of the world's largest CT scan databases of verified CT colonography data.
Medicsight LungCAD API is a medical imaging software tool designed to assist radiologists in the evaluation of pulmonary nodules on CT scans of the lung. Developed using one of the world's largest and most population-diverse CT scan databases, the product aims to assist radiologists in detecting lesions in the lung, such as nodules, while providing valuable information to the radiologist to assess patient images more effectively.
About MGT Capital Investments, Inc.
MGT Capital Investments is an investment company with two direct subsidiaries that focus solely on the dynamic and consolidating HCIT sector. The first subsidiary, Medicsight plc, is a leading developer of computer-aided detection (CAD) and computer assisted reader (CAR) software solutions that are validated using one of the world's largest databases of verified CT scan data. Medicsight's CAD and CAR products help clinicians identify, measure, and analyze suspicious pathology, such as colorectal polyps and lung lesions. MGT Capital Investments has invested in and controls a second subsidiary, Medicexchange plc, which operates Medicexchange.com, an online multi-vendor sales channel for diagnostic, treatment and surgery planning solutions for cardiac, thoracic, breast imaging, orthopedic, and gastro intestinal imaging. Medicexchange.com provides these solutions in a low-cost, on-demand and downloadable format, enhancing access to information and products for medical imaging professionals. Additional information can be found at http://www.mgtci.com.
All forward-looking statements are made pursuant to the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. Forward- looking statements are based on current management expectations that involve risks and uncertainties that may result in such expectations not being realized. Potential risks and uncertainties include, but are not limited to, the risks described in company filings with the Securities and Exchange Commission.
MGT Capital Investments, Inc.
http://www.mgtci.com
David Sumner, chief executive officer of Medicsight plc, commented, "We are extremely pleased to receive Canadian medical device licenses for our colon and lung CAD products. These approvals build on Medicsight's recent ColonCAR(TM) market release in the United States and Europe and expands the addressable market of our CAD products for the Company and its distribution partners."
Mr. Sumner continued, "Medicsight's ColonCAD addresses many of the difficulties faced by radiologists and has been designed to help unlock the full potential of virtual colonoscopy. Our LungCAD is designed to allow radiologists to detect and segment lung nodules at early stage, enhancing treatment options and disease management. For these reasons we believe that our products will be well received by the Canadian market and we will continue to work diligently to bring this important software to radiologists around the globe."
Medicsight's CAD products are designed to be seamlessly integrated into either 3D workstations or Picture Archiving Systems (PACS) and assist radiologists in the identification of potentially fatal lesions found in the lung and polyps found in the colon. Medicsight's CAD products are designed to improve radiologist workflow and productivity.
Medicsight ColonCAD API is an image-analysis software tool designed to be used with CT (computed tomography) colonography (virtual colonoscopy) to assist radiologists in detecting and measuring potential colorectal polyps. ColonCAD has been developed using one of the world's largest CT scan databases of verified CT colonography data.
Medicsight LungCAD API is a medical imaging software tool designed to assist radiologists in the evaluation of pulmonary nodules on CT scans of the lung. Developed using one of the world's largest and most population-diverse CT scan databases, the product aims to assist radiologists in detecting lesions in the lung, such as nodules, while providing valuable information to the radiologist to assess patient images more effectively.
About MGT Capital Investments, Inc.
MGT Capital Investments is an investment company with two direct subsidiaries that focus solely on the dynamic and consolidating HCIT sector. The first subsidiary, Medicsight plc, is a leading developer of computer-aided detection (CAD) and computer assisted reader (CAR) software solutions that are validated using one of the world's largest databases of verified CT scan data. Medicsight's CAD and CAR products help clinicians identify, measure, and analyze suspicious pathology, such as colorectal polyps and lung lesions. MGT Capital Investments has invested in and controls a second subsidiary, Medicexchange plc, which operates Medicexchange.com, an online multi-vendor sales channel for diagnostic, treatment and surgery planning solutions for cardiac, thoracic, breast imaging, orthopedic, and gastro intestinal imaging. Medicexchange.com provides these solutions in a low-cost, on-demand and downloadable format, enhancing access to information and products for medical imaging professionals. Additional information can be found at http://www.mgtci.com.
All forward-looking statements are made pursuant to the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. Forward- looking statements are based on current management expectations that involve risks and uncertainties that may result in such expectations not being realized. Potential risks and uncertainties include, but are not limited to, the risks described in company filings with the Securities and Exchange Commission.
MGT Capital Investments, Inc.
http://www.mgtci.com
Keeping an asthma diary
Keep your health in your hands
Asthma is a strange disease. Though it effects over 20 million people in the US alone, no two cases are exactly alike. Doctors now know that it is a genetic condition, meaning it is passed down from generation to generation (see it was your father's fault all along), but what varies greatly are the triggers which set off an attack. A trigger can be any external
Asthma is a strange disease. Though it effects over 20 million people in the US alone, no two cases are exactly alike. Doctors now know that it is a genetic condition, meaning it is passed down from generation to generation (see it was your father's fault all along), but what varies greatly are the triggers which set off an attack. A trigger can be any external
Intense Cessation Treatment Proves Successful In High-Risk Smokers
Hospitalized patients who undergo structured treatment to quit smoking are significantly more likely to remain smoke-free, says a new study. New research published in the February issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians (ACCP), suggests that high-risk smokers with acute cardiovascular disease are three to four times more likely to quit smoking when treated with an intensive smoking cessation program.
"Smoking is the greatest risk factor for patients with heart disease," said author Syed M. Mohiuddin, MD, FCCP, Creighton University Cardiac Center, Omaha, NE, "and our study showed that intense treatment intervention not only succeeded in getting patients to quit smoking, but it reduced hospitalizations and mortality, as well."
From January 2001 to December 2002, Dr. Mohiuddin and colleagues gathered 209 patients who were admitted to the coronary care unit at the Creighton University Cardiac Center, suffering from unstable angina, heart attack, or severe coronary heart disease. All of the patients were self-identified smokers and agreed to undergo smoking cessation intervention. Patients were then randomized into two groups: the intensive intervention group (109) and the usual care group (100).
Prior to hospital discharge, all patients received approximately 30 minutes of counseling and were given self-help materials. Treatment in the intervention group also included a minimum 12 weeks of behavior modification counseling, coupled with individualized pharmacotherapy. This included nicotine replacement therapy and/or bupropion at no cost to the patient. However, patients in the usual care group did not receive anything beyond the initial inpatient counseling session.
"The intensive component of tobacco cessation therapy was started while patients were hospitalized but continued after release," said Dr. Mohiuddin, "making the outpatient portion of this program the most significant element."
All participants returned at 3, 6, 12, and 24 months, during which follow- up medical histories and expired carbon monoxide levels were obtained. Patients who reported having not smoked during the previous evaluation period and who were confirmed by a negative expired carbon monoxide were classified as "abstinent." Those patients who were confirmed as not smoking by their expired carbon monoxide at every visit were classified as "continuously abstinent."
Compared with the usual care group, patients in the intensive treatment group had significantly higher quit rates at all follow-up time intervals. At the two-year follow-up, 39 percent of the intensive treatment group was continuously abstinent, compared with only 9 percent of the usual care group. Additionally, treatment was shown to reduce the risk of hospitalization by nearly half. Researchers also found that those in the control group were four times as likely to die than were patients in the intervention group.
"Cessation of smoking results in an almost immediate improvement in the risk of heart attack," said Dr. Mohiuddin, "and our study proves that intense smoking cessation treatment in high-risk patients is successful and that it saves lives."
"Smoking clearly links patients with cardiovascular disease to adverse outcomes," said Mark J. Rosen, MD, FCCP, President of the American College of Chest Physicians. "It's never too late to quit smoking and all patients who smoke should work with their doctors to find the quit method that works best for them."
CHEST is a peer-reviewed journal published by the ACCP. It is available online each month at http://www.chestjournal.org. The ACCP represents 16,500 members who provide clinical respiratory, sleep, critical care, and cardiothoracic patient care in the United States and throughout the world. The ACCP's mission is to promote the prevention and treatment of diseases of the chest through leadership, education, research, and communication. For more information about the ACCP, please visit the ACCP Web site at http://www.chestnet.org.
American College of Chest Physicians
http://www.chestnet.org
"Smoking is the greatest risk factor for patients with heart disease," said author Syed M. Mohiuddin, MD, FCCP, Creighton University Cardiac Center, Omaha, NE, "and our study showed that intense treatment intervention not only succeeded in getting patients to quit smoking, but it reduced hospitalizations and mortality, as well."
From January 2001 to December 2002, Dr. Mohiuddin and colleagues gathered 209 patients who were admitted to the coronary care unit at the Creighton University Cardiac Center, suffering from unstable angina, heart attack, or severe coronary heart disease. All of the patients were self-identified smokers and agreed to undergo smoking cessation intervention. Patients were then randomized into two groups: the intensive intervention group (109) and the usual care group (100).
Prior to hospital discharge, all patients received approximately 30 minutes of counseling and were given self-help materials. Treatment in the intervention group also included a minimum 12 weeks of behavior modification counseling, coupled with individualized pharmacotherapy. This included nicotine replacement therapy and/or bupropion at no cost to the patient. However, patients in the usual care group did not receive anything beyond the initial inpatient counseling session.
"The intensive component of tobacco cessation therapy was started while patients were hospitalized but continued after release," said Dr. Mohiuddin, "making the outpatient portion of this program the most significant element."
All participants returned at 3, 6, 12, and 24 months, during which follow- up medical histories and expired carbon monoxide levels were obtained. Patients who reported having not smoked during the previous evaluation period and who were confirmed by a negative expired carbon monoxide were classified as "abstinent." Those patients who were confirmed as not smoking by their expired carbon monoxide at every visit were classified as "continuously abstinent."
Compared with the usual care group, patients in the intensive treatment group had significantly higher quit rates at all follow-up time intervals. At the two-year follow-up, 39 percent of the intensive treatment group was continuously abstinent, compared with only 9 percent of the usual care group. Additionally, treatment was shown to reduce the risk of hospitalization by nearly half. Researchers also found that those in the control group were four times as likely to die than were patients in the intervention group.
"Cessation of smoking results in an almost immediate improvement in the risk of heart attack," said Dr. Mohiuddin, "and our study proves that intense smoking cessation treatment in high-risk patients is successful and that it saves lives."
"Smoking clearly links patients with cardiovascular disease to adverse outcomes," said Mark J. Rosen, MD, FCCP, President of the American College of Chest Physicians. "It's never too late to quit smoking and all patients who smoke should work with their doctors to find the quit method that works best for them."
CHEST is a peer-reviewed journal published by the ACCP. It is available online each month at http://www.chestjournal.org. The ACCP represents 16,500 members who provide clinical respiratory, sleep, critical care, and cardiothoracic patient care in the United States and throughout the world. The ACCP's mission is to promote the prevention and treatment of diseases of the chest through leadership, education, research, and communication. For more information about the ACCP, please visit the ACCP Web site at http://www.chestnet.org.
American College of Chest Physicians
http://www.chestnet.org
Sanofi-Aventis Announces Update To U.S. Prescribing Information For Ketek(R) (Telithromycin)
Sanofi-aventis today announced that the U.S. Food and Drug Administration (FDA) has approved revisions to the US Prescribing Information for Ketek(R) (telithromycin).
These revisions follow discussions with the FDA and are based on recommendations of a FDA Joint Advisory Committee meeting of the Drug Safety and Risk Management Advisory Committee and Anti-infective Drug Advisory Committee held in December 2006. The revisions include:
- A boxed warning to alert physicians and patients that the use of the drug is contraindicated in patients with myasthenia gravis (a rare autoimmune disease),
- Updated warnings about possible visual disturbances and loss of consciousness (syncope).
- Deletion of the indications for acute exacerbation of chronic bronchitis (AECB) and acute bacterial sinusitis (ABS).
Ketek(R) remains indicated in patients with mild to moderate community- acquired pneumonia (CAP) caused by susceptible pathogens, including multidrug- resistant Streptococcus pneumoniae (MDRSP).
Ketek(R), when used as directed in its approved indication continues to be an important option in the anti-infective armamentarium and helps to satisfy a medical need.
Ketek(R) is currently approved and marketed in over 50 countries. Since its launch, it is estimated that 28 million patients have been treated with Ketek(R) worldwide.
MORE INFORMATION
In consultation with the FDA, sanofi-aventis has prepared a Medication Guide to be distributed to patients along with every prescription of Ketek. The Medication Guide communicates the rare but potentially serious adverse events associated with the use of Ketek.
In the U.S., sanofi-aventis will inform healthcare professionals about the revisions to the U.S. prescribing information through a "Dear Healthcare Professional" letter, sales force educational communications to healthcare professionals and the posting of the updated prescribing information and Medication Guide on the company and product Web sites (http://www.sanofi- aventis.us and http://www.Ketek.com).
Sanofi-aventis will also be contacting several patient organizations concerned with myasthenia gravis to ensure these parties have the most updated information regarding the label change of Ketek.
Additional information regarding the Medication Guide and update to the Ketek prescribing information can be found on the FDA Web site.
About Ketek
Ketek is contraindicated in patients with myasthenia gravis. There have been reports of fatal and life-threatening respiratory failure in patients with myasthenia gravis associated with the use of Ketek.
KETEK tablets are indicated for the treatment of community-acquired pneumonia (of mild to moderate severity) due to Streptococcus pneumoniae, (including multi-drug resistant isolates [MDRSP*]), Haemophilus influenzae, Moraxella catarrhalis, Chlamydophila pneumoniae, or Mycoplasma pneumoniae, for patients 18 years old and above.
MDRSP, Multi-drug resistant Streptococcus pneumoniae includes isolates known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are isolates resistant to two or more of the following antibiotics: penicillin, 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.
KETEK is contraindicated in patients with myasthenia gravis. Exacerbations of myasthenia gravis have been reported in patients and sometimes occurred within a few hours of the first dose of telithromycin. Reports have included fatal and life-threatening acute respiratory failure with a rapid onset and progression.
KETEK is contraindicated in patients with previous history of hepatitis and/or jaundice associated with the use of KETEK tablets, or any macrolide antibiotic.
KETEK is contraindicated in patients with a history of hypersensitivity to telithromycin and/or any components of KETEK tablets, or any macrolide antibiotic.
Concomitant administration of KETEK with cisapride or pimozide is contraindicated.
Acute hepatic failure and severe liver injury, in some cases fatal, have been reported in patients treated with KETEK. These hepatic reactions included fulminant hepatitis and hepatic necrosis leading to liver transplant, and were observed during or immediately after treatment. In some of these cases, liver injury progressed rapidly and occurred after administration of a few doses of KETEK.
Physicians and patients should monitor for the appearance of signs or symptoms of hepatitis, such as fatigue, malaise, anorexia, nausea, jaundice, bilirubinuria, acholic stools, liver tenderness or hepatomegaly. Patients with signs or symptoms of hepatitis must be advised to discontinue KETEK and immediately seek medical evaluation, which should include liver function tests. If clinical hepatitis or transaminase elevations combined with other systemic symptoms occur, KETEK should be permanently discontinued.
Ketek must not be re-administered to patients with a previous history of hepatitis and/or jaundice associated with the use of KETEK tablets, or any macrolide antibiotic.
In addition, less severe hepatic dysfunction associated with increased liver enzymes, hepatitis and in some cases jaundice was reported with the use of KETEK. These events associated with less severe forms of liver toxicity were reversible.
Telithromycin has the potential to prolong the QTc interval of the electrocardiogram in some patients. QTc prolongation may lead to an increased risk for ventricular arrhythmias, including torsades de pointes. Thus, telithromycin should be avoided in patients with congenital prolongation of the QTc interval, and in patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (e.g., quinidine and procainamide) or Class III (e.g., dofetilide) antiarrhythmic agents.
Cases of torsades de pointes have been reported post-marketing with KETEK. In clinical trials, no cardiovascular morbidity or mortality attributable to QTc prolongation occurred with telithromycin treatment in 4780 patients in clinical trials, including 204 patients having a prolonged QTc at baseline.
KETEK may cause visual disturbances particularly in slowing the ability to accommodate and the ability to release accommodation. Visual disturbances included blurred vision, difficulty focusing, and diplopia. Most events were mild to moderate; however, severe cases have been reported.
There have been post-marketing adverse event reports of transient loss of consciousness including some cases associated with vagal syndrome.
Because of potential visual difficulties or loss of consciousness, patients should attempt to minimize activities such as driving a motor vehicle, operating heavy machinery or engaging in other hazardous activities during treatment with KETEK. If patients experience visual disorders or loss of consciousness while taking KETEK, patients should not drive a motor vehicle, operate heavy machinery or engage in other hazardous activities.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including KETEK, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C difficile, and surgical evaluation should be instituted as clinically indicated.
Therapy with simvastatin, lovastatin, or atorvastatin should be suspended during the course of KETEK treatment. Concomitant treatment of KETEK with rifampin, a CYP 3A4 inducer, should be avoided.
Most adverse events were mild to moderate and included diarrhea, nausea, headache, dizziness, and vomiting.
About sanofi-aventis
Sanofi-aventis is one of the world's leading pharmaceutical companies. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expect," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward- Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2005. Other than as required by applicable law, sanofi- aventis does not undertake any obligation to update or revise any forward- looking information or statements.
sanofi-aventis
http://www.sanofi-aventis.us
These revisions follow discussions with the FDA and are based on recommendations of a FDA Joint Advisory Committee meeting of the Drug Safety and Risk Management Advisory Committee and Anti-infective Drug Advisory Committee held in December 2006. The revisions include:
- A boxed warning to alert physicians and patients that the use of the drug is contraindicated in patients with myasthenia gravis (a rare autoimmune disease),
- Updated warnings about possible visual disturbances and loss of consciousness (syncope).
- Deletion of the indications for acute exacerbation of chronic bronchitis (AECB) and acute bacterial sinusitis (ABS).
Ketek(R) remains indicated in patients with mild to moderate community- acquired pneumonia (CAP) caused by susceptible pathogens, including multidrug- resistant Streptococcus pneumoniae (MDRSP).
Ketek(R), when used as directed in its approved indication continues to be an important option in the anti-infective armamentarium and helps to satisfy a medical need.
Ketek(R) is currently approved and marketed in over 50 countries. Since its launch, it is estimated that 28 million patients have been treated with Ketek(R) worldwide.
MORE INFORMATION
In consultation with the FDA, sanofi-aventis has prepared a Medication Guide to be distributed to patients along with every prescription of Ketek. The Medication Guide communicates the rare but potentially serious adverse events associated with the use of Ketek.
In the U.S., sanofi-aventis will inform healthcare professionals about the revisions to the U.S. prescribing information through a "Dear Healthcare Professional" letter, sales force educational communications to healthcare professionals and the posting of the updated prescribing information and Medication Guide on the company and product Web sites (http://www.sanofi- aventis.us and http://www.Ketek.com).
Sanofi-aventis will also be contacting several patient organizations concerned with myasthenia gravis to ensure these parties have the most updated information regarding the label change of Ketek.
Additional information regarding the Medication Guide and update to the Ketek prescribing information can be found on the FDA Web site.
About Ketek
Ketek is contraindicated in patients with myasthenia gravis. There have been reports of fatal and life-threatening respiratory failure in patients with myasthenia gravis associated with the use of Ketek.
KETEK tablets are indicated for the treatment of community-acquired pneumonia (of mild to moderate severity) due to Streptococcus pneumoniae, (including multi-drug resistant isolates [MDRSP*]), Haemophilus influenzae, Moraxella catarrhalis, Chlamydophila pneumoniae, or Mycoplasma pneumoniae, for patients 18 years old and above.
MDRSP, Multi-drug resistant Streptococcus pneumoniae includes isolates known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are isolates resistant to two or more of the following antibiotics: penicillin, 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.
KETEK is contraindicated in patients with myasthenia gravis. Exacerbations of myasthenia gravis have been reported in patients and sometimes occurred within a few hours of the first dose of telithromycin. Reports have included fatal and life-threatening acute respiratory failure with a rapid onset and progression.
KETEK is contraindicated in patients with previous history of hepatitis and/or jaundice associated with the use of KETEK tablets, or any macrolide antibiotic.
KETEK is contraindicated in patients with a history of hypersensitivity to telithromycin and/or any components of KETEK tablets, or any macrolide antibiotic.
Concomitant administration of KETEK with cisapride or pimozide is contraindicated.
Acute hepatic failure and severe liver injury, in some cases fatal, have been reported in patients treated with KETEK. These hepatic reactions included fulminant hepatitis and hepatic necrosis leading to liver transplant, and were observed during or immediately after treatment. In some of these cases, liver injury progressed rapidly and occurred after administration of a few doses of KETEK.
Physicians and patients should monitor for the appearance of signs or symptoms of hepatitis, such as fatigue, malaise, anorexia, nausea, jaundice, bilirubinuria, acholic stools, liver tenderness or hepatomegaly. Patients with signs or symptoms of hepatitis must be advised to discontinue KETEK and immediately seek medical evaluation, which should include liver function tests. If clinical hepatitis or transaminase elevations combined with other systemic symptoms occur, KETEK should be permanently discontinued.
Ketek must not be re-administered to patients with a previous history of hepatitis and/or jaundice associated with the use of KETEK tablets, or any macrolide antibiotic.
In addition, less severe hepatic dysfunction associated with increased liver enzymes, hepatitis and in some cases jaundice was reported with the use of KETEK. These events associated with less severe forms of liver toxicity were reversible.
Telithromycin has the potential to prolong the QTc interval of the electrocardiogram in some patients. QTc prolongation may lead to an increased risk for ventricular arrhythmias, including torsades de pointes. Thus, telithromycin should be avoided in patients with congenital prolongation of the QTc interval, and in patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (e.g., quinidine and procainamide) or Class III (e.g., dofetilide) antiarrhythmic agents.
Cases of torsades de pointes have been reported post-marketing with KETEK. In clinical trials, no cardiovascular morbidity or mortality attributable to QTc prolongation occurred with telithromycin treatment in 4780 patients in clinical trials, including 204 patients having a prolonged QTc at baseline.
KETEK may cause visual disturbances particularly in slowing the ability to accommodate and the ability to release accommodation. Visual disturbances included blurred vision, difficulty focusing, and diplopia. Most events were mild to moderate; however, severe cases have been reported.
There have been post-marketing adverse event reports of transient loss of consciousness including some cases associated with vagal syndrome.
Because of potential visual difficulties or loss of consciousness, patients should attempt to minimize activities such as driving a motor vehicle, operating heavy machinery or engaging in other hazardous activities during treatment with KETEK. If patients experience visual disorders or loss of consciousness while taking KETEK, patients should not drive a motor vehicle, operate heavy machinery or engage in other hazardous activities.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including KETEK, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C difficile, and surgical evaluation should be instituted as clinically indicated.
Therapy with simvastatin, lovastatin, or atorvastatin should be suspended during the course of KETEK treatment. Concomitant treatment of KETEK with rifampin, a CYP 3A4 inducer, should be avoided.
Most adverse events were mild to moderate and included diarrhea, nausea, headache, dizziness, and vomiting.
About sanofi-aventis
Sanofi-aventis is one of the world's leading pharmaceutical companies. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expect," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward- Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2005. Other than as required by applicable law, sanofi- aventis does not undertake any obligation to update or revise any forward- looking information or statements.
sanofi-aventis
http://www.sanofi-aventis.us
FDA Revises Label Warnings On The Antibiotic Ketek
The US Food and Drug Administration (FDA) has revised the label warnings on the antibiotic Ketek, to improve safe use by patients. Ketek is the brand name of Telithromycin and is manufactured by Sanofi-Aventis.
The FDA has removed approval of the drug for treatment of acute bacterial infections associated with sinusitis and chronic bronchitis. Ketek retains FDA approval for treatment of community acquired pneumonia of "mild to moderate severity" but it will carry a black box label, the most severe level of warning issued by the FDA.
The new label will warn that patients with the muscle weakness autoimmune disease myasthenia gravis should not take the drug. It will also carry a stronger warning about potential side effects such as "visual disturbances" and "loss of consciousness".
This is the second time that Ketek's label has changed in the last 12 months. In June last year the label was strengthened to point out the danger of hepatic toxicity ( a rare but severe symptom of liver disease).
Dr Steven Galson, Director at the Center for Drug Evaluation and Research said the "Action is the result of comprehensive scientific analysis and thoughtful public discussion of the data available for Ketek, and includes important changes in the labeling designed to improve the safe use of Ketek by patients and give healthcare providers the most up-to-date prescribing information."
A new patient information leaflet will also accompany the prescription, explaining the drug's safe use and risks.
These changes reflect the advice given out in December last year by the FDA's Anti-Infective Drugs and Drug Safety and Risk Management Advisory Committees.
The committees pointed out that since the drug was approved in April 2004, new evidence shows that the balance of risks versus benefits has changed. Much of this relates to cases of liver damage, disturbed vision and loss of consciousness.
Dr John Jenkins, Director at the FDA's Center for Drug Evaluation and Research, Office of New Drugs, said that the new benefits versus risk assessment does not support the use of Ketek for self-limited and less serious illnesses such as sinusitis and bronchitis.
But he said the drug will continue to be "approved for community-acquired pneumonia of mild to moderate severity, which is a more serious illness that generally does not resolve without antibiotic therapy."
According to reports by the Associated Press the FDA's handling of Ketek is under Senate investigation. Also, today is the day that the House of Representatives Subcommittee on Oversight and Investigations is hearing witness statements on "The Adequacy of FDA Efforts to Assure the Safety of the Drug Supply", which according to a Bloomberg press report yesterday includes "irregularities in the approval of Ketek".
The drug has a somewhat tortuous pharmacological history. A group of antiobiotics called macrolides was developed to treat people allergic to penicillin. But then some bacteria became macrolide resistant. Enter the Ketolides - developed to defeat the macrolide-resistant bacteria that cause respiratory infections.
Telithromycin (the generic name for Ketek) is a ketolide antibiotic with a similar structure to one of the macrolides - Erythromycin. It works by stopping the bacteria from being able to produce protein which limits the spread of the colony in the respiratory tract.
Telithromycin is metabolized mostly in the liver and has a half life in the body of about 10 hours.
Click here for more information on Telithromycin from the FDA.
Click here for more information on Telithromycin from wikipedia.
Written by: Catharine Paddock
Writer: Medical News Today
Survival In Asbestos-Related Cancer Improved By Chemo Combination
People with mesothelioma - a form of cancer associated with asbestos exposure - have a higher survival rate when treated with a combination of two cancer drugs, a large multicenter study finds.
Mesothelioma, a rare but aggressive form of cancer that occurs in the lining of the lungs, heart and abdomen, is associated with exposure to asbestos. There is no known cure.
In the study, patients receiving pemetrexed and cisplatin - along with the vitamin supplements folic acid and B12 - survived nearly three months longer than patients getting cisplatin alone.
Researchers led by John Green, M.D., at the Clatterbridge Center for Oncology in England, reviewed a study of 448 patients with advanced mesothelioma who were treated with either the single drug or the combination.
"Pemetrexed used in combination with cisplatin significantly increases the length of survival, when compared with cisplatin alone," the researchers say. "Further research is needed into the optimum treatment regimen for pleural mesothelioma."
The review appears in the current issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.
The researchers examined data from a clinical trial of 20 treatment centers in Europe, the Americas, Australia and Asia. Eighty-one percent of the patients were men, with an average age of 61. Patients who received the combination treatment survived an average 2.8 months longer.
Patients receiving both medications also reported improved quality of life in terms of fatigue, loss of appetite, pain and cough.
During the early stages of the trial, patients receiving pemetrexed had serious symptoms of toxicity, including drug-related death. Other side effects included blood cell abnormalities, nausea and diarrhea, which decreased in both incidence and severity after the vitamins were added to the treatment. People who work trades such as shipbuilding, railway engineering, construction work and asbestos manufacture have higher rates of mesothelioma than the general public. The cancer may take 10 to 60 years to develop, and the risk does not diminish after exposure to asbestos has stopped. Family members of people exposed to asbestos at work also have an increased risk of developing mesothelioma from asbestos fibers carried home on the clothes of the people they live with.
Daniel Baram, M.D., a pulmonologist at the Lung Cancer Evaluation Center at the State University of New York, said, "Most cases [of mesothelioma] are still from pre-OSHA workplace improvements. I suspect that modern asbestos abatement precautions will avoid most, if not all, future cases. The latency is over 30 years, so we are still diagnosing cases with exposure during World War II and the '40s and '50s."
Mesothelioma is difficult to diagnose, Green said, because "there is a lag of many years between exposure and asbestosis, which is a nonmalignant condition, and a greater lag before the development of overt malignancy."
"There is no way of diagnosing the premalignant phase during the latent period of 15 to 20 years," Green added. "Many of these patients smoke and are in economically disadvantaged communities. Many individuals have moved away from heavy industries and may not admit or know they were exposed to asbestos as young men, with similar issues for their partners."
According to the U.S. Environmental Protection Agency, 10 percent to 15 percent of schools and other public buildings in the United States contain asbestos insulation.
Although safety measures for working with asbestos have been in place since the 1970s, mesothelioma is projected to account for 65,000 deaths between 2001 and 2050 worldwide, peaking between 2012 and 2015, according to background information in the review.
It is a personal matter as to whether the survival increase for patients receiving the two drugs is worthwhile, Baram said. "It depends in large part on the patient. A 2.8-month mean survival increase means that some patients may get even more than that, though some people will get less. Many, if not most, patients when faced with a disease with a very bad prognosis are often willing to undergo aggressive therapy, although the toxicity is serious and potentially life-threatening."
###
By Lise Millay Stevens, Contributing Writer
Health Behavior News Service
Green J, et al. Pemetrexed disodium in combination with cisplatin versus other cytotoxic agents or supportive care for the treatment of malignant pleural mesothelioma. Cochrane Database of Systematic Reviews 2007, Issue 1.
The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit http://www.cochrane.org/ for more information.
Contact: Lisa Esposito
Center for the Advancement of Health
Mesothelioma, a rare but aggressive form of cancer that occurs in the lining of the lungs, heart and abdomen, is associated with exposure to asbestos. There is no known cure.
In the study, patients receiving pemetrexed and cisplatin - along with the vitamin supplements folic acid and B12 - survived nearly three months longer than patients getting cisplatin alone.
Researchers led by John Green, M.D., at the Clatterbridge Center for Oncology in England, reviewed a study of 448 patients with advanced mesothelioma who were treated with either the single drug or the combination.
"Pemetrexed used in combination with cisplatin significantly increases the length of survival, when compared with cisplatin alone," the researchers say. "Further research is needed into the optimum treatment regimen for pleural mesothelioma."
The review appears in the current issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.
The researchers examined data from a clinical trial of 20 treatment centers in Europe, the Americas, Australia and Asia. Eighty-one percent of the patients were men, with an average age of 61. Patients who received the combination treatment survived an average 2.8 months longer.
Patients receiving both medications also reported improved quality of life in terms of fatigue, loss of appetite, pain and cough.
During the early stages of the trial, patients receiving pemetrexed had serious symptoms of toxicity, including drug-related death. Other side effects included blood cell abnormalities, nausea and diarrhea, which decreased in both incidence and severity after the vitamins were added to the treatment. People who work trades such as shipbuilding, railway engineering, construction work and asbestos manufacture have higher rates of mesothelioma than the general public. The cancer may take 10 to 60 years to develop, and the risk does not diminish after exposure to asbestos has stopped. Family members of people exposed to asbestos at work also have an increased risk of developing mesothelioma from asbestos fibers carried home on the clothes of the people they live with.
Daniel Baram, M.D., a pulmonologist at the Lung Cancer Evaluation Center at the State University of New York, said, "Most cases [of mesothelioma] are still from pre-OSHA workplace improvements. I suspect that modern asbestos abatement precautions will avoid most, if not all, future cases. The latency is over 30 years, so we are still diagnosing cases with exposure during World War II and the '40s and '50s."
Mesothelioma is difficult to diagnose, Green said, because "there is a lag of many years between exposure and asbestosis, which is a nonmalignant condition, and a greater lag before the development of overt malignancy."
"There is no way of diagnosing the premalignant phase during the latent period of 15 to 20 years," Green added. "Many of these patients smoke and are in economically disadvantaged communities. Many individuals have moved away from heavy industries and may not admit or know they were exposed to asbestos as young men, with similar issues for their partners."
According to the U.S. Environmental Protection Agency, 10 percent to 15 percent of schools and other public buildings in the United States contain asbestos insulation.
Although safety measures for working with asbestos have been in place since the 1970s, mesothelioma is projected to account for 65,000 deaths between 2001 and 2050 worldwide, peaking between 2012 and 2015, according to background information in the review.
It is a personal matter as to whether the survival increase for patients receiving the two drugs is worthwhile, Baram said. "It depends in large part on the patient. A 2.8-month mean survival increase means that some patients may get even more than that, though some people will get less. Many, if not most, patients when faced with a disease with a very bad prognosis are often willing to undergo aggressive therapy, although the toxicity is serious and potentially life-threatening."
###
By Lise Millay Stevens, Contributing Writer
Health Behavior News Service
Green J, et al. Pemetrexed disodium in combination with cisplatin versus other cytotoxic agents or supportive care for the treatment of malignant pleural mesothelioma. Cochrane Database of Systematic Reviews 2007, Issue 1.
The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit http://www.cochrane.org/ for more information.
Contact: Lisa Esposito
Center for the Advancement of Health
New York Mayor Urges Federal Government To Pay For Sept 11 Health Care
New York Mayor Michael Bloomberg called on the US government to inject 1 billion dollars into a Sept 11 victims' compensation fund that closed in 2004. He said the City cannot afford to foot the bill for the claims that will come forward from people with health problems emerging years after the collapse of the World Trade Centre.
Bloomberg says that the City's bill for dealing with the health problems caused by Sept 11 will cost nearly 400 million dollars a year and it can't afford to do this without federal support.
A recent report commissioned by the mayor says that the city has spent over 2 billion dollars in the last five years on diagnosing and treating citizens with health issues arising out of the trade centre collapse.
He said they could not afford to provide the care that people deserved in the longer term.
He also asked for 150 million dollars a year to support people with physical and mental health problems arising directly from Sept 11.
According to the 80 page report by the World Trade Center Health Panel set up by the Mayor, over 400,000 citizens who were exposed to the toxins in the smoke and dust which lingered for weeks while the twin towers burned qualify for health monitoring. Some 71,000 of them have registered with a scheme that will monitor their health for the next 20 years.
Many of the people who fell ill had mental health and lung problems.
Following the recommendations of the Health Panel, the Mayor held a briefing at a City Hall, where he said that the federal government should as a minimum fund these essential needs and that anything less would be "turning their backs on those who responded with courage and suffering".
US Representative and Manhattan Democrat Jerrold Nadler, and New York Democrat and Senator Hillary Clinton have brought in legislation to give New York funds towards the clean up operation and for treating people with illnesses caused by the dust and toxins arising from the burning aftermath of the towers.
The Mayor said that one of the research programmes the City would establish is to track the progress of cancer and other diseases being diagnosed in uniformed and civilian first responders, including 34,000 police officers and several thousand firefighters.
Another programme would double the diagonostic and treatment capacity to 12,000 patients at Bellevue Hospital for immigrants and residents of Chinatown.
Mayor Bloomberg said if victims aren't compensated for the injuries and illnesses they suffer as a result of helping with the clear up, one might question whether people would be so willing to come forward so selflessly should another disaster occur.
He said the the first responders were "responding to an act of war against this nation," and that meant federal government had a clear responsibility to meet here.
Federal funds amounting to 20 billion dollars in the form of aid and tax concessions have been awarded for the rebuilding of the lower Manhattan area. President Bush has also allocated 25 million in his recent budget to pay for health care for emergency workers.
The World Trade Center Health Panel said the current federal plans for supporting the health care of the people affected by Sept 11 were "modest and short term". They are suggesting the focus needs to be on the longer term too.
The September 11th Fund Home Page.
Written by: Catharine Paddock
Writer: Medical News Today
Why Only Some Cystic Fibrosis Patients Respond To Treatments That Prevent The Generation Of Truncated Proteins
Individuals with the genetic lung disorder cystic fibrosis (CF) lack any functional CFTR protein because their genes that encode this protein carry a mutation. One mutation (the W1282X mutation) that results in CF does so because it causes the cellular machinery that converts the initial product of a gene (mRNA) into a functional protein to prematurely stop making CFTR protein. Agents (such as gentamicin) that enable the protein-generating machinery to ignore such mutations have shown benefit in some, but not all, CF patients with the W1282X mutation. In a study that appears online in advance of publication in the March print issue of the Journal of Clinical Investigation, researchers from The Hebrew University of Jerusalem, Israel, describe a potential molecular explanation for the distinct responsiveness of patients with Cf to treatment with gentamicin.
Batsheva Kerem and colleagues found that CF patients with the W1282X mutation who responded to treatment with gentamicin expressed more nonsense CFTR mRNA than patients who did not respond to treatment. Further analysis showed that different cell lines from CF patients with the W1282X mutation had distinct abilities to destroy nonsense mRNA. Inhibiting the destruction of nonsense mRNA in these cell lines increased the amount of nonsense CFTR mRNA present, making them more susceptible to the ability of gentamicin to induce the production of functional CFTR protein. This study suggests that the ability of an individual's affected cells to destroy nonsense mRNA determines how responsive CF patients with the W1282X mutation are likely to be to treatment with gentamicin. Such observations might also extend to other genetic disorders in which mutations causing the cellular machinery to prematurely stop making protein have been identified, such as Duchenne muscular dystrophy.
TITLE: Nonsense-mediated mRNA decay affects nonsense transcript levels and governs response of cystic fibrosis patients to gentamicin
AUTHOR CONTACT:
Batsheva Kerem
The Hebrew University of Jerusalem, Jerusalem, Israel.
###
JCI table of contents -- February 8, 2006
Contact: Karen Honey
Journal of Clinical Investigation
Batsheva Kerem and colleagues found that CF patients with the W1282X mutation who responded to treatment with gentamicin expressed more nonsense CFTR mRNA than patients who did not respond to treatment. Further analysis showed that different cell lines from CF patients with the W1282X mutation had distinct abilities to destroy nonsense mRNA. Inhibiting the destruction of nonsense mRNA in these cell lines increased the amount of nonsense CFTR mRNA present, making them more susceptible to the ability of gentamicin to induce the production of functional CFTR protein. This study suggests that the ability of an individual's affected cells to destroy nonsense mRNA determines how responsive CF patients with the W1282X mutation are likely to be to treatment with gentamicin. Such observations might also extend to other genetic disorders in which mutations causing the cellular machinery to prematurely stop making protein have been identified, such as Duchenne muscular dystrophy.
TITLE: Nonsense-mediated mRNA decay affects nonsense transcript levels and governs response of cystic fibrosis patients to gentamicin
AUTHOR CONTACT:
Batsheva Kerem
The Hebrew University of Jerusalem, Jerusalem, Israel.
###
JCI table of contents -- February 8, 2006
Contact: Karen Honey
Journal of Clinical Investigation
Astrazeneca Launches A Smarter Approach To Asthma Management In Europe
AstraZeneca today announced that 37 countries to date have received approval of Symbicort® Maintenance And Reliever Therapy (Symbicort SMART®), and that a period of world wide launches will now be initiated. This new, smarter approach to asthma is the first to provide patients with both asthma maintenance and reliever therapy together in just one inhaler.
With the Symbicort SMART management approach, patients receive inhaled corticosteroid (ICS) and long acting bronchodilator (LABA) with every inhalation. Thus, with Symbicort SMART it is possible to treat the underlying inflammation with every inhalation, even when used for rapid symptom relief, making it a more effective way to manage asthma. A separate SABA (short acting bronchodilator) inhaler is therefore no longer needed. Symbicort SMART has been proven to reduce exacerbations by 39% compared with salmeterol / fluticasone combination and a separate reliever medication.1
The Symbicort SMART treatment approach is possible only because Symbicort combines two components in one inhaler: budesonide, an ICS to provide an anti-inflammatory effect in the airways, and formoterol, a unique bronchodilator that is both rapid in effect and long lasting (LABA). The other LABA available for maintenance treatment of asthma, salmeterol, does not have the properties that enables it to be used in this way. Consequently, Seretide™ (salmeterol/fluticasone) can not be used in the same way as Symbicort SMART. Patients on Symbicort SMART receive a maintenance dose in line with normal practice to establish asthma control and can then take additional inhalations 'as needed' if symptoms occur, to provide both rapid symptom relief and increased asthma control in the longer term.
"We know that patients tend to over-rely on their symptom relief inhaler when experiencing a worsening of their symptoms," comments Professor Claus Vogelmeier, Professor of Medicine and Head of Pulmonary Division, Marburg University Hospital Germany, and speaker at the official Symbicort SMART launch event in Lund. "Although patients consistently adjust their medication in response to asthma variations, often the adjustment in maintenance therapy is delayed in response to an exacerbation. With Symbicort SMART, physicians can be sure that patients are receiving their anti-inflammatory treatment with every inhalation, ensuring their asthma is better controlled."
The Symbicort SMART approach is recognised by the Global Initiative for Asthma (GINA) who recently announced revised international treatment guidelines on best practice in the prevention and treatment of asthma. The guidelines support the need for a new management approach - Symbicort SMART.2
"Previous editions of the GINA Guidelines have perhaps led to an impression that mild asthma could be equated to mild symptoms and severe asthma to severe symptoms, which we know is not the case," comments Dr Paul O'Byrne, McMaster University, Ontario, Canada and Chair of the GINA Executive Committee. "Asthma is a variable disease and the GINA Committee felt that a treatment approach based upon effective control of symptoms and exacerbations would better reflect the natural course of the disease. The result will be improved outcomes by allowing treatment to be rapidly increased when symptoms first appear and then brought back down again when control is achieved, and thus let the dosing respond quickly to the patients' asthma control status."
Symbicort SMART has been tested extensively in a wide clinical trial program involving over 14,000 patients with persistent asthma. These studies consistently show that Symbicort SMART, irrespective of asthma severity, reduces the risk of patients developing potentially life-threatening asthma attacks compared with traditional treatment approaches such as fixed dosing with either higher doses of ICS plus a short-acting bronchodilator (SABA) or with an ICS/LABA combination therapy plus a SABA. 1, 3-7
In the EU, Symbicort SMART is licensed for use in adults with a need for ICS / LABA combination treatment. National launches are expected throughout the EU over the coming months.
"We are delighted to announce the launch of Symbicort SMART in Europe," said Dr John Patterson, Executive Director, Development for AstraZeneca. "This new treatment approach will simplify asthma management and has the potential to improve the lives of a great many asthma patients. We now have a management approach that provides the reassurance of instant relief when needed and in the same breath treats the underlying disease for the long term. This is a significant step forward for asthma patients."
To date, Symbicort has been effectively and widely used as a traditional maintenance treatment for asthmatics across the world. With the advent of today's launch of Symbicort SMART, Symbicort is the first maintenance therapy to als
o be proven effective and licensed for maintenance and reliever therapy in one inhaler. AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
For further updates, news and information on Symbicort, please visit
http://www.astrazenecapressoffice.com
References
1. Kuna P, Peters MJ, Buhl R. Budesonide/formoterol as maintenance and reliever therapy reduces asthma exacerbations versus a higher maintenance dose of budesonide/formoterol or salmeterol/fluticasone. Abstract presented at the ERS Congress 2006.
2. The Global Initiative for Asthma (GINA). GINA Report, Global Strategy for Asthma Management and Prevention, published November 2006. www.ginasthma.com
3. Rabe K, Atienza T, Magyar P et al. Reduction in asthma exacerbations with budesonide in combination with formoterol for reliever therapy: a randomised, controlled, double-blind study. Lancet 2006;368: 744-53.
4. Vogelmeier C, D'Urzo A, Pauwels R, Merino JM, Jaspal M, Boutet S, Naya I, Price D. Budesonide/formoterol maintenance and reliever therapy: an effective asthma treatment option? Eur Respir J 2005; 26(5): 819-828.
5. O'Byrne P, Bisgaard H, Godard P, Pistolesi M, Palmqvist M, Zhu Y, EkstrГPm T, Bateman E. Budesonide/Formoterol Combination Therapy as Both Maintenance and Reliever Medication in Asthma. American Journal of Respiratory and Critical Care Medicine 2005; 171(2): 129-136.
6. Scicchitano R, Aalbers R, Ukena D, Manjra A, Fouquert L, Centanni S, Boulet L-P, Naya IP, Hultquist C. Efficacy and safety of budesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma. Current Medical Research and Opinion 2004;20(9):1403-18.
7. Klaus F. Rabe, Emilio Pizzichini, BjГPrn StГ¤llberg, Santiago Romero, Ana M. Balanzat, Tito Atienza, Per Arve Lier, and Carin Jorup, Budesonide/Formoterol in a Single Inhaler for Maintenance and Relief in Mild-to-Moderate Asthma: A Randomized, Double-Blind Trial, Chest, Feb 2006; 129: 246 - 256
Symbicort SMART -- Symbicort SMART improves daily symptom control and reduces asthma attacks while patients only need one inhaler*. A separate short-acting bronchodilator is no longer needed. Patients prescribed Symbicort SMART, take a maintenance dose of Symbicort every day in line with normal practice to establish asthma control and take additional inhalations 'as needed' of Symbicort if symptoms occur, to provide both rapid symptom relief and improved asthma control. *not indicated for prophylactic use before exercise
-- Symbicort SMART successfully completed the European Union Mutual Recognition Procedure (MRP) in October 2006
-- Symbicort SMART is currently approved in 37 countries worldwide
-- Symbicort is currently approved in more than 90 countries; sales were $585 million in the first half 2006 (up 24 percent on 2005 figures) and have now reached more than five million treatment years
-- Symbicort received FDA approval in the US in July 2006 for maintenance treatment of asthma (in patients from 12 years of age)
Asthma -- Asthma is a chronic inflammatory condition of the airways characterised by reversible airway obstruction. It is a variable condition that can change both daily and seasonally
-- Most asthma patients require maintenance treatment with an inhaled corticosteroid (ICS), which suppresses the underlying airway inflammation, and a bronchodilator, which relaxes the smooth muscle of the airways.
With the Symbicort SMART management approach, patients receive inhaled corticosteroid (ICS) and long acting bronchodilator (LABA) with every inhalation. Thus, with Symbicort SMART it is possible to treat the underlying inflammation with every inhalation, even when used for rapid symptom relief, making it a more effective way to manage asthma. A separate SABA (short acting bronchodilator) inhaler is therefore no longer needed. Symbicort SMART has been proven to reduce exacerbations by 39% compared with salmeterol / fluticasone combination and a separate reliever medication.1
The Symbicort SMART treatment approach is possible only because Symbicort combines two components in one inhaler: budesonide, an ICS to provide an anti-inflammatory effect in the airways, and formoterol, a unique bronchodilator that is both rapid in effect and long lasting (LABA). The other LABA available for maintenance treatment of asthma, salmeterol, does not have the properties that enables it to be used in this way. Consequently, Seretide™ (salmeterol/fluticasone) can not be used in the same way as Symbicort SMART. Patients on Symbicort SMART receive a maintenance dose in line with normal practice to establish asthma control and can then take additional inhalations 'as needed' if symptoms occur, to provide both rapid symptom relief and increased asthma control in the longer term.
"We know that patients tend to over-rely on their symptom relief inhaler when experiencing a worsening of their symptoms," comments Professor Claus Vogelmeier, Professor of Medicine and Head of Pulmonary Division, Marburg University Hospital Germany, and speaker at the official Symbicort SMART launch event in Lund. "Although patients consistently adjust their medication in response to asthma variations, often the adjustment in maintenance therapy is delayed in response to an exacerbation. With Symbicort SMART, physicians can be sure that patients are receiving their anti-inflammatory treatment with every inhalation, ensuring their asthma is better controlled."
The Symbicort SMART approach is recognised by the Global Initiative for Asthma (GINA) who recently announced revised international treatment guidelines on best practice in the prevention and treatment of asthma. The guidelines support the need for a new management approach - Symbicort SMART.2
"Previous editions of the GINA Guidelines have perhaps led to an impression that mild asthma could be equated to mild symptoms and severe asthma to severe symptoms, which we know is not the case," comments Dr Paul O'Byrne, McMaster University, Ontario, Canada and Chair of the GINA Executive Committee. "Asthma is a variable disease and the GINA Committee felt that a treatment approach based upon effective control of symptoms and exacerbations would better reflect the natural course of the disease. The result will be improved outcomes by allowing treatment to be rapidly increased when symptoms first appear and then brought back down again when control is achieved, and thus let the dosing respond quickly to the patients' asthma control status."
Symbicort SMART has been tested extensively in a wide clinical trial program involving over 14,000 patients with persistent asthma. These studies consistently show that Symbicort SMART, irrespective of asthma severity, reduces the risk of patients developing potentially life-threatening asthma attacks compared with traditional treatment approaches such as fixed dosing with either higher doses of ICS plus a short-acting bronchodilator (SABA) or with an ICS/LABA combination therapy plus a SABA. 1, 3-7
In the EU, Symbicort SMART is licensed for use in adults with a need for ICS / LABA combination treatment. National launches are expected throughout the EU over the coming months.
"We are delighted to announce the launch of Symbicort SMART in Europe," said Dr John Patterson, Executive Director, Development for AstraZeneca. "This new treatment approach will simplify asthma management and has the potential to improve the lives of a great many asthma patients. We now have a management approach that provides the reassurance of instant relief when needed and in the same breath treats the underlying disease for the long term. This is a significant step forward for asthma patients."
To date, Symbicort has been effectively and widely used as a traditional maintenance treatment for asthmatics across the world. With the advent of today's launch of Symbicort SMART, Symbicort is the first maintenance therapy to als
o be proven effective and licensed for maintenance and reliever therapy in one inhaler. AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
For further updates, news and information on Symbicort, please visit
http://www.astrazenecapressoffice.com
References
1. Kuna P, Peters MJ, Buhl R. Budesonide/formoterol as maintenance and reliever therapy reduces asthma exacerbations versus a higher maintenance dose of budesonide/formoterol or salmeterol/fluticasone. Abstract presented at the ERS Congress 2006.
2. The Global Initiative for Asthma (GINA). GINA Report, Global Strategy for Asthma Management and Prevention, published November 2006. www.ginasthma.com
3. Rabe K, Atienza T, Magyar P et al. Reduction in asthma exacerbations with budesonide in combination with formoterol for reliever therapy: a randomised, controlled, double-blind study. Lancet 2006;368: 744-53.
4. Vogelmeier C, D'Urzo A, Pauwels R, Merino JM, Jaspal M, Boutet S, Naya I, Price D. Budesonide/formoterol maintenance and reliever therapy: an effective asthma treatment option? Eur Respir J 2005; 26(5): 819-828.
5. O'Byrne P, Bisgaard H, Godard P, Pistolesi M, Palmqvist M, Zhu Y, EkstrГPm T, Bateman E. Budesonide/Formoterol Combination Therapy as Both Maintenance and Reliever Medication in Asthma. American Journal of Respiratory and Critical Care Medicine 2005; 171(2): 129-136.
6. Scicchitano R, Aalbers R, Ukena D, Manjra A, Fouquert L, Centanni S, Boulet L-P, Naya IP, Hultquist C. Efficacy and safety of budesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma. Current Medical Research and Opinion 2004;20(9):1403-18.
7. Klaus F. Rabe, Emilio Pizzichini, BjГPrn StГ¤llberg, Santiago Romero, Ana M. Balanzat, Tito Atienza, Per Arve Lier, and Carin Jorup, Budesonide/Formoterol in a Single Inhaler for Maintenance and Relief in Mild-to-Moderate Asthma: A Randomized, Double-Blind Trial, Chest, Feb 2006; 129: 246 - 256
Symbicort SMART -- Symbicort SMART improves daily symptom control and reduces asthma attacks while patients only need one inhaler*. A separate short-acting bronchodilator is no longer needed. Patients prescribed Symbicort SMART, take a maintenance dose of Symbicort every day in line with normal practice to establish asthma control and take additional inhalations 'as needed' of Symbicort if symptoms occur, to provide both rapid symptom relief and improved asthma control. *not indicated for prophylactic use before exercise
-- Symbicort SMART successfully completed the European Union Mutual Recognition Procedure (MRP) in October 2006
-- Symbicort SMART is currently approved in 37 countries worldwide
-- Symbicort is currently approved in more than 90 countries; sales were $585 million in the first half 2006 (up 24 percent on 2005 figures) and have now reached more than five million treatment years
-- Symbicort received FDA approval in the US in July 2006 for maintenance treatment of asthma (in patients from 12 years of age)
Asthma -- Asthma is a chronic inflammatory condition of the airways characterised by reversible airway obstruction. It is a variable condition that can change both daily and seasonally
-- Most asthma patients require maintenance treatment with an inhaled corticosteroid (ICS), which suppresses the underlying airway inflammation, and a bronchodilator, which relaxes the smooth muscle of the airways.
High Rates Of Latent TB Infection Found In Russian Health Workers
Testing for tuberculosis has revealed that nearly 40% of the doctors in one Russian city have latent infection, with even higher levels in those who work in TB clinics. The research has been published in PLoS Medicine.
TB disease is a growing problem worldwide. Russia is one country where it is particularly common. Although up to a third of the world's population are infected with the bacterium that causes the disease, in most people the infection remains 'latent'. It is important to detect latent infection in order to reduce the spread of the infection and to hold back the rise in the number of active cases. Working in Samara City in the Russian Federation, researchers from Queen Mary College, UK and colleagues in Samara, tested both health workers and students for latent TB. All the health staff, including students, were found to have higher rates of infection than other people in Samara. The 47% infection rate found in staff in TB clinics was ten times higher than that in the population at large.
The study authors say that, although more research is first needed, it may be necessary to conduct regular occupational health screening for latent infection followed by treatment where appropriate. However, even this may not be effective in controlling rates of active infection, as resistance to TB drugs is so common.
###
Everything published by PLoS Medicine is Open Access: freely available for anyone to read, download, redistribute and otherwise use, as long as the authorship is properly attributed.
Note: The test used by the researchers was not the 'traditional' tuberculin skin test, as this is not reliable when used with people who were given the 'BCG' vaccination for TB early in life, which is common in Russia as in many other countries. The new 'IFN-gamma' test gave good results and the researchers recommend that it be used in further research of this kind.
Citation: Drobniewski F, Balabanova Y, Zakamova E, Nikolayevskyy V, Fedorin I (2007) Rates of latent tuberculosis in health care staff in Russia. PLoS Med 4(2): e55.
PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT
CONTACT:
Francis Drobniewski
Barts and the London School of Medicine and Dentistry
Queen Mary College
University of London
2 Newark Street
London, E1 2AT United Kingdom
Contact: Andrew Hyde
Public Library of Science
TB disease is a growing problem worldwide. Russia is one country where it is particularly common. Although up to a third of the world's population are infected with the bacterium that causes the disease, in most people the infection remains 'latent'. It is important to detect latent infection in order to reduce the spread of the infection and to hold back the rise in the number of active cases. Working in Samara City in the Russian Federation, researchers from Queen Mary College, UK and colleagues in Samara, tested both health workers and students for latent TB. All the health staff, including students, were found to have higher rates of infection than other people in Samara. The 47% infection rate found in staff in TB clinics was ten times higher than that in the population at large.
The study authors say that, although more research is first needed, it may be necessary to conduct regular occupational health screening for latent infection followed by treatment where appropriate. However, even this may not be effective in controlling rates of active infection, as resistance to TB drugs is so common.
###
Everything published by PLoS Medicine is Open Access: freely available for anyone to read, download, redistribute and otherwise use, as long as the authorship is properly attributed.
Note: The test used by the researchers was not the 'traditional' tuberculin skin test, as this is not reliable when used with people who were given the 'BCG' vaccination for TB early in life, which is common in Russia as in many other countries. The new 'IFN-gamma' test gave good results and the researchers recommend that it be used in further research of this kind.
Citation: Drobniewski F, Balabanova Y, Zakamova E, Nikolayevskyy V, Fedorin I (2007) Rates of latent tuberculosis in health care staff in Russia. PLoS Med 4(2): e55.
PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT
CONTACT:
Francis Drobniewski
Barts and the London School of Medicine and Dentistry
Queen Mary College
University of London
2 Newark Street
London, E1 2AT United Kingdom
Contact: Andrew Hyde
Public Library of Science
Ethiopians With TB Must Overcome Barriers To Complete Treatment
One in five Ethiopians treated for tuberculosis fails to complete the length course of drugs required, according to a study by Ethiopian and Norwegian researchers, published in PLoS Medicine. The research has made clear some of the difficulties that patients must overcome in order to succeed in completing a course of treatment. People who cannot easily travel to a treatment centre are the most likely to 'default'.
Tuberculosis is one of the world's leading causes of death and the number of cases is increasing. Ethiopia is one of the worst affected countries. The treatment recommended by the World Health Organization (WHO) can be very effective for most patients but it does involve taking drugs for at least six months. Patients may find it difficult to complete the full treatment, although it helps to have a system where trained observers help make sure that each patient takes all the necessary pills. WHO promotes this approach - known as DOTS (directly observed treatment short course) - and says national programs should aim for a treatment completion rate of at least 85%. Ethiopia was already known to have made good progress towards this goal during the 1990s. However, the researchers wanted to know why those people still not completing treatment were failing to do so.
They studied over 400 patients diagnosed and registered for treatment in a hospital in Hossana Hospital in southern Ethiopia over a two-year period. Using questionnaires they recorded information about the patients' circumstances. They recorded who completed or failed to complete treatment and analysed their data to determine which factors were most closely associated with failure to complete.
The overall completion rate was 80% (i.e. 20% failed to complete), still some way short of the WHO target. The patients who needed to use public transport, which is expensive for many Ethiopians, in order to reach a treatment centre were the most likely to fail to complete. This was despite the fact most of the patients in the study lived in less remote areas than the majority of southern Ethiopians. Other factors were also noted; for example people aged over 25 were less likely to finish their treatment.
The researchers concluded that it will be necessary for the Ethiopian government to continue to expand its efforts to improve access to treatment centres for patients with TB.
###
Everything published by PLoS Medicine is Open Access: freely available for anyone to read, download, redistribute and otherwise use, as long as the authorship is properly attributed.
Citation: Shargie EB, LindtjГёrn B (2007) Determinants of treatment adherence among smear-positive pulmonary tuberculosis patients in southern Ethiopia. PLoS Med 4(2): e37.
PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT
CONTACT:
Estifanos Shargie
Centre for International Health,
University of Bergen
Bergen, Norway
About PLoS Medicine
PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues. For more information, visit http://www.plosmedicine.org/
About the Public Library of Science
The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world's scientific and medical literature a freely available public resource. For more information, visit http://www.plos.org/
Contact: Andrew Hyde
Public Library of Science
Tuberculosis is one of the world's leading causes of death and the number of cases is increasing. Ethiopia is one of the worst affected countries. The treatment recommended by the World Health Organization (WHO) can be very effective for most patients but it does involve taking drugs for at least six months. Patients may find it difficult to complete the full treatment, although it helps to have a system where trained observers help make sure that each patient takes all the necessary pills. WHO promotes this approach - known as DOTS (directly observed treatment short course) - and says national programs should aim for a treatment completion rate of at least 85%. Ethiopia was already known to have made good progress towards this goal during the 1990s. However, the researchers wanted to know why those people still not completing treatment were failing to do so.
They studied over 400 patients diagnosed and registered for treatment in a hospital in Hossana Hospital in southern Ethiopia over a two-year period. Using questionnaires they recorded information about the patients' circumstances. They recorded who completed or failed to complete treatment and analysed their data to determine which factors were most closely associated with failure to complete.
The overall completion rate was 80% (i.e. 20% failed to complete), still some way short of the WHO target. The patients who needed to use public transport, which is expensive for many Ethiopians, in order to reach a treatment centre were the most likely to fail to complete. This was despite the fact most of the patients in the study lived in less remote areas than the majority of southern Ethiopians. Other factors were also noted; for example people aged over 25 were less likely to finish their treatment.
The researchers concluded that it will be necessary for the Ethiopian government to continue to expand its efforts to improve access to treatment centres for patients with TB.
###
Everything published by PLoS Medicine is Open Access: freely available for anyone to read, download, redistribute and otherwise use, as long as the authorship is properly attributed.
Citation: Shargie EB, LindtjГёrn B (2007) Determinants of treatment adherence among smear-positive pulmonary tuberculosis patients in southern Ethiopia. PLoS Med 4(2): e37.
PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT
CONTACT:
Estifanos Shargie
Centre for International Health,
University of Bergen
Bergen, Norway
About PLoS Medicine
PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues. For more information, visit http://www.plosmedicine.org/
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The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world's scientific and medical literature a freely available public resource. For more information, visit http://www.plos.org/
Contact: Andrew Hyde
Public Library of Science
Spray Drying Technique Created For TB Vaccine
Bioengineers and public health researchers have developed a novel spray drying method for preserving and delivering the most common tuberculosis (TB) vaccine. The low-cost and scaleable technique offers several potential advantages over conventional freezing procedures, such as greater stability at room temperature and use in needle-free delivery. The spray drying process could one day provide a better approach for vaccination against TB and help prevent the related spread of HIV/AIDS in the developing world.
The research team led by Yun-Ling Wong, a graduate researcher in bioengineering, and David Edwards, Gordon McKay Professor of the Practice of Biomedical Engineering, both at the Harvard School of Engineering and Applied Sciences, and Barry R. Bloom, Dean of the Harvard School of Public Health and Joan L. and Julius H. Jacobson Professor of Public Health, was sponsored in part by the Bill and Melinda Gates Foundation. The work appeared in the February 13 edition of the Proceedings of the National Academy of Sciences.
"With the increasing incidence of tuberculosis and drug resistant disease in developing countries due to HIV/AIDS, there is a need for vaccines that are more effective than the present Bacillus Calmette-GuГ(c)rin (BCG) vaccine," said Wong. "An optimal new vaccine would obviate needle injection, not require refrigerated storage, and provide a safe and more consistent degree of protection."
BCG, while the most widely administered childhood vaccine in the world, with 100 million infant administrations annually, is presently dried by freezing - or lyophilization - and delivered by needle injection. The commercial formulation requires refrigerated storage and has shown variable degrees of protection against tuberculosis in different parts of the world. Because of such limitations, public health experts and physicians have long seen a need for alternatives to the traditional BCG vaccine and current treatment strategies.
"The breakthrough for developing the spray drying process involved removing salts and cryoprotectants like glycerol from bacterial suspensions," explains Edwards. "This is counter to conventional thinking: that bacteria be dried in the presence of salts and cryoprotectants. While these substances are generally required for normal storage and freezing protocols, in the case of evaporative drying as occurs in spray drying, salt and cryoprotectants act like knives that press on the bacterial membrane with great force and inactivate the bacteria. By removing these, we managed to save the bacteria and achieve better stability."
The spray drying process developed for the BCG vaccine is similar to the way manufacturers prepare powdered milk. In fact, Edwards' first exposure to the spray drying process occurred when he was working with a spray dryer to produce highly respirable drug aerosols in a food science lab. While spray drying of small and large molecules is common in the food, cosmetic and pharmaceutical industries, the method has not been commonly used for drying cellular material. Most important, the new technique enables the BCG vaccine, and potentially other bacterial and viral based vaccines, to be dried without the traditional problems associated with standard freezing.
"Unlike traditional freezing techniques, spray drying is lower cost, easily scaleable for manufacturing, and ideal for use in aerosol (needle free) formulations, such as inhalation," says Wong. "Its greater stability at room temperature and viability ultimately could provide a more practical approach for creating and delivering a vaccine throughout the world."
Edwards, an international leader in aerosol drug and vaccine delivery, sees great promise for the advance, which he and his colleagues hope to develop in the next few years for better vaccination approaches for diseases of poverty through the international not-for-profit Medicine in Need (Mend), based in Cambridge, Paris, and Cape Town, South Africa.
"With the emergence of multidrug and extremely drug resistant TB, we hope this breakthrough is one more step to help us develop a stable vaccine to stem the tide of disease," says Bloom. "Better vaccination against TB can go a long way to addressing the current developing world health care crisis, with TB alone presently taking the lives of more than 2 million people a year. And we believe this method could also be used to improve delivery of many other vaccines."
###
Wong, Edwards, and Bloom's co-authors included Samantha Sampson and Sunali Goonesekera (Harvard School of Public Health); Willem Andreas Germishuizen (Harvard School of Engineering and Applied Sciences); Giovanni Caponetti (Eratech), Jerry Sadoff (Aeras Global TB Vaccine Foundation). The work was supported by a Grand Challenge Grant from the Bill and Melinda Gates Foundation and with a grant from the National Institutes of Health.
Contact: Michael Patrick Rutter
Harvard University
The research team led by Yun-Ling Wong, a graduate researcher in bioengineering, and David Edwards, Gordon McKay Professor of the Practice of Biomedical Engineering, both at the Harvard School of Engineering and Applied Sciences, and Barry R. Bloom, Dean of the Harvard School of Public Health and Joan L. and Julius H. Jacobson Professor of Public Health, was sponsored in part by the Bill and Melinda Gates Foundation. The work appeared in the February 13 edition of the Proceedings of the National Academy of Sciences.
"With the increasing incidence of tuberculosis and drug resistant disease in developing countries due to HIV/AIDS, there is a need for vaccines that are more effective than the present Bacillus Calmette-GuГ(c)rin (BCG) vaccine," said Wong. "An optimal new vaccine would obviate needle injection, not require refrigerated storage, and provide a safe and more consistent degree of protection."
BCG, while the most widely administered childhood vaccine in the world, with 100 million infant administrations annually, is presently dried by freezing - or lyophilization - and delivered by needle injection. The commercial formulation requires refrigerated storage and has shown variable degrees of protection against tuberculosis in different parts of the world. Because of such limitations, public health experts and physicians have long seen a need for alternatives to the traditional BCG vaccine and current treatment strategies.
"The breakthrough for developing the spray drying process involved removing salts and cryoprotectants like glycerol from bacterial suspensions," explains Edwards. "This is counter to conventional thinking: that bacteria be dried in the presence of salts and cryoprotectants. While these substances are generally required for normal storage and freezing protocols, in the case of evaporative drying as occurs in spray drying, salt and cryoprotectants act like knives that press on the bacterial membrane with great force and inactivate the bacteria. By removing these, we managed to save the bacteria and achieve better stability."
The spray drying process developed for the BCG vaccine is similar to the way manufacturers prepare powdered milk. In fact, Edwards' first exposure to the spray drying process occurred when he was working with a spray dryer to produce highly respirable drug aerosols in a food science lab. While spray drying of small and large molecules is common in the food, cosmetic and pharmaceutical industries, the method has not been commonly used for drying cellular material. Most important, the new technique enables the BCG vaccine, and potentially other bacterial and viral based vaccines, to be dried without the traditional problems associated with standard freezing.
"Unlike traditional freezing techniques, spray drying is lower cost, easily scaleable for manufacturing, and ideal for use in aerosol (needle free) formulations, such as inhalation," says Wong. "Its greater stability at room temperature and viability ultimately could provide a more practical approach for creating and delivering a vaccine throughout the world."
Edwards, an international leader in aerosol drug and vaccine delivery, sees great promise for the advance, which he and his colleagues hope to develop in the next few years for better vaccination approaches for diseases of poverty through the international not-for-profit Medicine in Need (Mend), based in Cambridge, Paris, and Cape Town, South Africa.
"With the emergence of multidrug and extremely drug resistant TB, we hope this breakthrough is one more step to help us develop a stable vaccine to stem the tide of disease," says Bloom. "Better vaccination against TB can go a long way to addressing the current developing world health care crisis, with TB alone presently taking the lives of more than 2 million people a year. And we believe this method could also be used to improve delivery of many other vaccines."
###
Wong, Edwards, and Bloom's co-authors included Samantha Sampson and Sunali Goonesekera (Harvard School of Public Health); Willem Andreas Germishuizen (Harvard School of Engineering and Applied Sciences); Giovanni Caponetti (Eratech), Jerry Sadoff (Aeras Global TB Vaccine Foundation). The work was supported by a Grand Challenge Grant from the Bill and Melinda Gates Foundation and with a grant from the National Institutes of Health.
Contact: Michael Patrick Rutter
Harvard University
Statement On The Passing Of Congressman Charlie Norwood (R-GA), By John Kirkwood, American Lung Association President & CEO
The American Lung Association's volunteers and staff wish to express our deepest condolences to family of U.S. Congressman Charlie Norwood, DDS (R-GA), who died today after a long battle with idiopathic pulmonary fibrosis and lung cancer. A long-time champion for all patients, Representative Norwood inspired lung disease patients across the country when he returned to Congress following his lung transplant in 2004. American Lung Association staff and volunteers fondly remember Representative Norwood's keynote speech to our national conference in May 2002.
Idiopathic pulmonary fibrosis is a form of interstitial lung disease. When a person has idiopathic pulmonary fibrosis, the lung is affected in three ways. First, the lung tissue is damaged in some known or unknown way. Second, the walls of the air sacs in the lung become inflamed. Finally, scarring (or fibrosis) begins in the interstitium (or tissue between the air sacs), and the lung becomes stiff. The American Lung Association supports an array of research into the basic cellular and molecular processes that underlie the inflammatory response in the lungs that precedes pulmonary fibrosis. Our researchers are also examining new ways to prevent the lung scarring that follows this type of inflammation and are looking for new treatments for lungs damaged excess scar tissue formation.
Lung cancer is the number one cancer killer in the U.S., and the American Lung Association is committed to funding vital research to help fight this devastating disease including our Lung Cancer Discovery Award which is specifically directed at developing improved treatments. Lung cancer may also be the most tragic cancer because in most cases, it might have been prevented. Nearly 90 percent of lung cancer cases are caused by smoking. The more time and amount you smoke, the greater your risk of lung cancer. But if you stop smoking, the risk of lung cancer decreases each year as normal cells replace abnormal cells.
About the American Lung Association
Beginning our second century, the American Lung Association is the leading organization working to prevent lung disease and promote lung health. Lung disease death rates continue to increase while other leading causes of death have declined. The American Lung Association funds vital research on the causes of and treatments for lung disease. With the generous support of the public, the American Lung Association is "Improving life, one breath at a time." For more information about the American Lung Association or to support the work it does, call 1-800-LUNG-USA ( 1-800-586-4872) or log on to http://www.lungusa.org.
Idiopathic pulmonary fibrosis is a form of interstitial lung disease. When a person has idiopathic pulmonary fibrosis, the lung is affected in three ways. First, the lung tissue is damaged in some known or unknown way. Second, the walls of the air sacs in the lung become inflamed. Finally, scarring (or fibrosis) begins in the interstitium (or tissue between the air sacs), and the lung becomes stiff. The American Lung Association supports an array of research into the basic cellular and molecular processes that underlie the inflammatory response in the lungs that precedes pulmonary fibrosis. Our researchers are also examining new ways to prevent the lung scarring that follows this type of inflammation and are looking for new treatments for lungs damaged excess scar tissue formation.
Lung cancer is the number one cancer killer in the U.S., and the American Lung Association is committed to funding vital research to help fight this devastating disease including our Lung Cancer Discovery Award which is specifically directed at developing improved treatments. Lung cancer may also be the most tragic cancer because in most cases, it might have been prevented. Nearly 90 percent of lung cancer cases are caused by smoking. The more time and amount you smoke, the greater your risk of lung cancer. But if you stop smoking, the risk of lung cancer decreases each year as normal cells replace abnormal cells.
About the American Lung Association
Beginning our second century, the American Lung Association is the leading organization working to prevent lung disease and promote lung health. Lung disease death rates continue to increase while other leading causes of death have declined. The American Lung Association funds vital research on the causes of and treatments for lung disease. With the generous support of the public, the American Lung Association is "Improving life, one breath at a time." For more information about the American Lung Association or to support the work it does, call 1-800-LUNG-USA ( 1-800-586-4872) or log on to http://www.lungusa.org.
EPA Rule Slashes Toxics From Gasoline, Vehicles, And Portable Fuel Containers - USA
Toxic fumes from gasoline, vehicles and fuel containers will decrease significantly, further reducing health risks under tough new standards signed today by EPA Administrator Stephen L. Johnson. By 2030, EPA's new Mobile Source Air Toxic (MSAT) regulations and fuel and vehicle standards already in place will reduce toxic emissions from cars to 80 percent below 1999 emissions.
"Americans love their cars. By clearing the air from tons of fuel and exhaust pollution, President Bush and EPA are paving the road toward healthier drivers and a cleaner environment," said EPA Administrator Stephen L. Johnson.
The MSAT rule toughens benzene standards for gasoline, sets hydrocarbon emissions standards for cars at cold temperatures and tightens fuel containers to prevent the evaporation of harmful fumes.
Once the new standards are fully implemented in 2030, they are expected to reduce emissions of mobile source air toxics annually by 330,000 tons, including 61,000 tons of benzene. EPA estimates annual health benefits from the particulate matter reductions of the vehicle standards to total $6 billion in 2030. The estimated annual cost for the entire rule is about $400 million in 2030.
The new MSAT standards will take effect in 2011 for gasoline, 2010 for cars, and 2009 for fuel containers.
Click here for a copy of this final rule
http://yosemite.epa.gov
"Americans love their cars. By clearing the air from tons of fuel and exhaust pollution, President Bush and EPA are paving the road toward healthier drivers and a cleaner environment," said EPA Administrator Stephen L. Johnson.
The MSAT rule toughens benzene standards for gasoline, sets hydrocarbon emissions standards for cars at cold temperatures and tightens fuel containers to prevent the evaporation of harmful fumes.
Once the new standards are fully implemented in 2030, they are expected to reduce emissions of mobile source air toxics annually by 330,000 tons, including 61,000 tons of benzene. EPA estimates annual health benefits from the particulate matter reductions of the vehicle standards to total $6 billion in 2030. The estimated annual cost for the entire rule is about $400 million in 2030.
The new MSAT standards will take effect in 2011 for gasoline, 2010 for cars, and 2009 for fuel containers.
Click here for a copy of this final rule
http://yosemite.epa.gov
Respiratory Research About To Experience Influx Of Talented Young Scientists, UK
The field of respiratory research is about to experience an influx of talented young scientists. Twenty-one PhD students will soon begin research projects that address the role of factors as diverse as fungi, viral infection, immune system reactions and the influence of maternal diet on the serious respiratory disorders asthma, chronic obstructive pulmonary disease (COPD) and other conditions.
The research awards have been made in response to the growing number of people in the UK who suffer from respiratory disease. The medical research charities Asthma UK, the British Lung Foundation and the British Thoracic Society (with the Morriston Davies Trust) have joined together with the Medical Research Council to fund the studentships.
They hope that by encouraging young scientists to study conditions that affect the respiratory system, there will be a greater capacity to develop treatments and knowledge of these illnesses in the future.
The funding collaboration was prompted by the report of a workshop attended by clinicians, scientists, research charities and other research funders in October 2005. The report reviewed the current standing and future of respiratory medicine research in the UK.
Professor Stephen Holgate, Chair of the UK Respiratory Research Strategy Committee, said: "More and more people in the UK are becoming ill as a result of respiratory conditions. Two major disease areas, lung cancer and lung fibrosis, were still under-represented in the research applications but this simply highlights why it is so important that we encourage young scientists to begin their careers in respiratory research, build their knowledge and find out more about how and why these conditions are on the rise so that we can offer effective treatments in the future. All of the funding partners believe the collaboration is a fantastic opportunity to strengthen respiratory research."
Twelve awards will be available in 2007 and a further nine in 2008. Students all over the UK will carry out a three or four year research project and receive training in research methods and key personal skills. The first awards have been made to scientists in Aberdeen, Edinburgh, Southampton, Manchester, Nottingham, Leicester, Glasgow, Leeds, Sheffield and London.
http://www.asthma.org.uk
The research awards have been made in response to the growing number of people in the UK who suffer from respiratory disease. The medical research charities Asthma UK, the British Lung Foundation and the British Thoracic Society (with the Morriston Davies Trust) have joined together with the Medical Research Council to fund the studentships.
They hope that by encouraging young scientists to study conditions that affect the respiratory system, there will be a greater capacity to develop treatments and knowledge of these illnesses in the future.
The funding collaboration was prompted by the report of a workshop attended by clinicians, scientists, research charities and other research funders in October 2005. The report reviewed the current standing and future of respiratory medicine research in the UK.
Professor Stephen Holgate, Chair of the UK Respiratory Research Strategy Committee, said: "More and more people in the UK are becoming ill as a result of respiratory conditions. Two major disease areas, lung cancer and lung fibrosis, were still under-represented in the research applications but this simply highlights why it is so important that we encourage young scientists to begin their careers in respiratory research, build their knowledge and find out more about how and why these conditions are on the rise so that we can offer effective treatments in the future. All of the funding partners believe the collaboration is a fantastic opportunity to strengthen respiratory research."
Twelve awards will be available in 2007 and a further nine in 2008. Students all over the UK will carry out a three or four year research project and receive training in research methods and key personal skills. The first awards have been made to scientists in Aberdeen, Edinburgh, Southampton, Manchester, Nottingham, Leicester, Glasgow, Leeds, Sheffield and London.
http://www.asthma.org.uk
Hospital Performance Measures May Not Accurately Reflect Quality Of Care Or Predict Patient Outcomes
A comparison of hospitals with high and low Medicare performance measures found little difference in the rate of death for three common conditions at the hospitals, indicating that the measures may not accurately reflect patient outcomes, according to a study in the December 13 issue of JAMA.
In the United States, quality of care delivered in hospitals is often variable. Because it is assumed that measuring quality of care is a key component in improving care, quality measurement has an increasingly prominent role in quality improvement, according to background information in the article. These measures can provide an incentive to improve the quality of the care delivered and to influence consumer choice of hospitals and health care plans. While some research has documented an association between higher adherence to care guidelines and better outcomes of patients who receive that care, to date there has been limited evidence demonstrating that hospitals that perform better on process measures also have better overall quality.
Rachel M. Werner, M.D., Ph.D., of the Philadelphia Veterans Affairs Medical Center, Philadelphia, and Eric T. Bradlow, Ph.D., of the University of Pennsylvania, Philadelphia, conducted a study to determine whether certain quality measures are correlated with and predictive of hospitals' risk-adjusted death rates. The researchers analyzed data from Hospital Compare, a website of the Centers for Medicare & Medicaid Services (CMS) that reports results of hospital performance measures. This study included data on hospital care between Jan. 1 and Dec. 31, 2004, for heart attack, heart failure, and pneumonia at acute care hospitals included on the Hospital Compare website. Ten process performance measures were compared with hospital risk-adjusted death rates, which were measured using Medicare Part A claims data. A total of 3,657 acute care hospitals were included in the study based on their performance reported in Hospital Compare.
Across all heart attack performance measures, the absolute reduction in risk-adjusted death rates between hospitals performing in the 25th percentile vs. those performing in the 75th percentile was 0.005 for inpatient death, 0.006 for 30-day death, and 0.012 for death at 1-year. For the heart failure performance measures, the absolute death reduction was smaller, ranging from 0.001 for inpatient death to 0.002 for 1-year death. For the pneumonia performance measures, the absolute reduction in death ranged from 0.001 for 30-day death to 0.005 for inpatient death.
"Our study suggests that in the case of hospital performance, the CMS's current set of performance measures are not tightly linked to patient outcomes. These findings should not undermine current efforts to improve health care quality through performance measurement and reporting. However, attention should be focused on finding measures of health care quality that are more tightly linked to patient outcomes. Only then will performance measurement live up to expectations for improving health care quality," the authors conclude.
(JAMA. 2006;296:2694-2702.)
Dr. Werner was supported by a career development award from the Department of Veterans Affairs. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Commentary: Performance Measures and Clinical Outcomes
In an accompanying commentary, Susan D. Horn, Ph.D., of the Institute for Clinical Outcomes Research, Salt Lake City, discusses the findings concerning hospital performance measures.
Dr. Horn notes, "The results of this study raise questions about the appropriateness of using Hospital Compare performance measures as the basis either for pay-for-performance systems or for consumers to identify better-quality hospitals. If performance measures are not strongly associated with better outcomes, why should clinicians and health care centers be required to collect and submit the data, and why would payers and consumers want to act on them""
"As the study by Werner and Bradlow illustrates, current simplistic process measures based on randomized controlled trials (RCTs) do not necessarily provide a meaningful basis for consumers to choose one clinician or hospital over another, or for clinicians or hospitals to improve their outcomes. In the real world where multiple clinical variables and patient factors affect outcomes, RCTs and comprehensive observational studies both have a role to play in improving patient care: the effects of RCTs in clinical practice can be examined in observational studies and observational studies can be progenitors [originators] for new RCTs. Patients, physicians, and policymakers will all benefit from efforts to evaluate rigorously and further understand the relationship between performance measures and clinical outcomes."
(JAMA. 2006;296:2731-2732.)
Dr. Horn reports that she in an employee, officer, shareholder, and founder of International Severity Information Systems Inc., which provides products and services to facilitate studies on practice-based evidence for clinical improvement.
###
Contact: Judi Cheary
JAMA and Archives Journals
In the United States, quality of care delivered in hospitals is often variable. Because it is assumed that measuring quality of care is a key component in improving care, quality measurement has an increasingly prominent role in quality improvement, according to background information in the article. These measures can provide an incentive to improve the quality of the care delivered and to influence consumer choice of hospitals and health care plans. While some research has documented an association between higher adherence to care guidelines and better outcomes of patients who receive that care, to date there has been limited evidence demonstrating that hospitals that perform better on process measures also have better overall quality.
Rachel M. Werner, M.D., Ph.D., of the Philadelphia Veterans Affairs Medical Center, Philadelphia, and Eric T. Bradlow, Ph.D., of the University of Pennsylvania, Philadelphia, conducted a study to determine whether certain quality measures are correlated with and predictive of hospitals' risk-adjusted death rates. The researchers analyzed data from Hospital Compare, a website of the Centers for Medicare & Medicaid Services (CMS) that reports results of hospital performance measures. This study included data on hospital care between Jan. 1 and Dec. 31, 2004, for heart attack, heart failure, and pneumonia at acute care hospitals included on the Hospital Compare website. Ten process performance measures were compared with hospital risk-adjusted death rates, which were measured using Medicare Part A claims data. A total of 3,657 acute care hospitals were included in the study based on their performance reported in Hospital Compare.
Across all heart attack performance measures, the absolute reduction in risk-adjusted death rates between hospitals performing in the 25th percentile vs. those performing in the 75th percentile was 0.005 for inpatient death, 0.006 for 30-day death, and 0.012 for death at 1-year. For the heart failure performance measures, the absolute death reduction was smaller, ranging from 0.001 for inpatient death to 0.002 for 1-year death. For the pneumonia performance measures, the absolute reduction in death ranged from 0.001 for 30-day death to 0.005 for inpatient death.
"Our study suggests that in the case of hospital performance, the CMS's current set of performance measures are not tightly linked to patient outcomes. These findings should not undermine current efforts to improve health care quality through performance measurement and reporting. However, attention should be focused on finding measures of health care quality that are more tightly linked to patient outcomes. Only then will performance measurement live up to expectations for improving health care quality," the authors conclude.
(JAMA. 2006;296:2694-2702.)
Dr. Werner was supported by a career development award from the Department of Veterans Affairs. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Commentary: Performance Measures and Clinical Outcomes
In an accompanying commentary, Susan D. Horn, Ph.D., of the Institute for Clinical Outcomes Research, Salt Lake City, discusses the findings concerning hospital performance measures.
Dr. Horn notes, "The results of this study raise questions about the appropriateness of using Hospital Compare performance measures as the basis either for pay-for-performance systems or for consumers to identify better-quality hospitals. If performance measures are not strongly associated with better outcomes, why should clinicians and health care centers be required to collect and submit the data, and why would payers and consumers want to act on them""
"As the study by Werner and Bradlow illustrates, current simplistic process measures based on randomized controlled trials (RCTs) do not necessarily provide a meaningful basis for consumers to choose one clinician or hospital over another, or for clinicians or hospitals to improve their outcomes. In the real world where multiple clinical variables and patient factors affect outcomes, RCTs and comprehensive observational studies both have a role to play in improving patient care: the effects of RCTs in clinical practice can be examined in observational studies and observational studies can be progenitors [originators] for new RCTs. Patients, physicians, and policymakers will all benefit from efforts to evaluate rigorously and further understand the relationship between performance measures and clinical outcomes."
(JAMA. 2006;296:2731-2732.)
Dr. Horn reports that she in an employee, officer, shareholder, and founder of International Severity Information Systems Inc., which provides products and services to facilitate studies on practice-based evidence for clinical improvement.
###
Contact: Judi Cheary
JAMA and Archives Journals
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