New Rules for Asthma-Med Makers

Sep 06, 2007
By Pharmaceutical Executive Editors

For the first time in 10 years, the National Institutes of Health (NIH) has released new guidelines for the diagnosis and treatment of asthma.

The report, Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma, focuses on control of the disease and new methods of monitoring and treating asthma--including medications. The report also includes an expanded section on childhood asthma with an additional age group, new recommendations on patient education, and advice for controlling environmental factors.

"The gist is that patients with asthma should be able to lead, for the most part, a normal life," said Hal Nelson, an allergist at the National Jewish Medical and Research Center and a member of the National Heart, Lung, and Blood Institute (NHLBI) advisory team. "They should be on appropriate treatment, but once the treatment is instituted, changes in treatment should be made depending on how well their asthma is controlled."

According to Nelson, good control means not having symptoms during the day, not waking up at night, not having to rely on a rescue inhaler, and being able to live a normal life. If a patient is meeting these goals, then he or she is well controlled?his or her medication is working, and he or she should be periodically watched to see if treatment could be reduced.

The guidelines specifically recommend inhaled corticosteroids as the most effective long-term control medication. Additional recommendations include:

•Leukotriene receptor antagonists (LTRAs) and cromolyn for long-term control. The class of LTRAs includes Merck's Singulair (montelukast) and AstraZeneca's Accolate (zafirlukast).

•Long-acting beta agonists as adjunct therapy with inhaled corticosteroids; the class includes eformoterol (found in Foradil from Novartis and Schering-Plough and in AstraZeneca's Oxis) and salmeterol (GSK's Serevent).

•The monoclonal antibody omalizumab [GK: I think it's supposed to be omalizumab. I added the o. Please verify.] (Genentech and Novartis' Xolair) for severe asthma; and albuterol, levalbuterol, and corticosteroids for acute exacerbations.

Aimed primarily at the primary care physician, the guidelines were established in the late 1980s by NHLBI and National Asthma Education Prevention Program to help lower the death rate from asthma. The first guidelines appeared in 1991, and they were revised in 1997.

Due to the lack of studies addressing the treatments available to asthma patients at the time it was written, the original document was written based on the opinions of an expert panel. Over the years, in part because of the issues raised in the guidelines, detailed studies have been released, allowing for a much more data-driven document with very little expert opinion.

"When the first guidelines came out in 1990, very few asthmatics were on inhaled corticoid steroids," Nelson said. Since 1990, there has been a steady increase in the percentage of asthmatics who are being treated with inhaled steroids, and as a result, the death rate has declined steadily since 1996 (it has declined by a third with the most recent data).

"Things are going in the right direction, it's just a question of trying harder," Nelson said. "There are still 3,700 people a year who die from asthma in the United Sates, and most of those deaths are preventable, if people are on adequate treatment."

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