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Asthma drug increases risk for patients, according to study

Written by: Staff

Washington, July 8 (UNI) The use of bronchodilators, a popular asthma medication, increases the risk of hospitalization and death for users, according to a new study published in a recent issue of the Annals of Internal Medicine.

While there has been previous evidence that the drugs might cause adverse reactions in a small number of patients, this study -- an analysis of 19 previous studies on the drugs -- suggests the danger might exist for a wider range of patients.

Bronchodilators (beta-agonists) work by relaxing the muscle bands that tighten around airways, rapidly opening the airways and letting more air into the lungs. Long-acting bronchodilators (LABAs), such as Advair, Foradil, and Serevent, work slowly over a 12-hour period. The active ingredient in Serevent is salmeterol, while Advair is a combination of salmeterol and fluticasone, an inhaled corticosteroid. The active ingredient in Foradil is Formoterol.

This latest study is not the first to raise concerns over the drugs. Previous trials showed an increase in asthma-related deaths and life-threatening experiences in patients on the medication. A research trial on patients using salmeterol followed 26,000 participants around for six months and found a four-fold increase in the number of asthma-related deaths.

After a review of the drugs in July 2005, an FDA advisory committee recommended new black box warning labels on Advair, Serevent, and Foradil. In November, FDA agreed, and asked the manufacturers (GlaxoSmithKline for Advair and Serevent, and Novartis for Foradil) for labeling changes.

The new meta-analysis published now summarized the data from 19 previous trials involving a total of 33,826 participants with asthma. The study found that the risks for severe exacerbations and asthma-related deaths were increased between two and four-fold.

''We must also look at the absolute risk increase to put this into clinical perspective. We found that the absolute increase in asthma-related deaths was estimated to be .06 per cent to .07 per cent over six months, indicating that long-acting beta-agonists cause an excess of approximately one death per 1,000 patient-years of use,'' the study's authors said.

According to the authors, salmeterol ''may be responsible for approximately 4,000 to 5,000 asthma-related deaths that occur in the United States each year.'' However, the researchers did admit to some limitations adherent in their analysis. ''Standard meta-analytic results for ORs (odds ratio) and risk differences can be uncertain when the numbers of events per study are small, as is the case with asthma-related deaths,'' they noted. ''The accurate assessment of asthma-related deaths in this analysis was further hindered by the fact that many trials did not provide this information.'' In an accompanying editorial in that issue of the Annals of Internal Medicine, Dr. Jeffrey Glassroth said, while LABAs are obviously potent, complex drugs that must be used with care, there are factors that ave yet to be fully examined.

''The study does not completely address the possible roles of disease severity, co-treatments, and adherence in causing serious adverse outcomes, presumably because too few studies reported this information,'' the editorial states.

According to GlaxoSmithKline spokesperson the study contains no new information and that all the studies used in the analysis have already been considered by the FDA in its labeling decisions.

''It contains no new safety information and no new data. The bulk of the data is at least three years old. It's data that was considered by (FDA) as recently as last year,'' said the spokesperson. ''Some of the key conclusions in the article are inconsistent with the larger body of evidence and real world experience of patients, the spokesperson added.


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