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Asthma Treatment Has Risks, Study Says

Jan 27, 2003 | The Oregonian

A drug company study has linked the popular asthma medication Serevent to a small risk of death or serious illness in some patients.

The inhaled drug, made by GlaxoSmithKline, which conducted the study, helps relax the muscles around tiny air passages in the lungs to help ward off asthma attacks. The long-acting Serevent, in a class of drugs known as beta-agonists, is used to help prevent asthma attacks rather than to stop an attack once it has started.

Asthma experts say the benefits of Serevent outweigh the risks if the drug is taken in combination with inhaled corticosteroids. Those drugs block the inflammation that plays a large part in the disease.

GlaxoSmithKline discontinued the study, which began in 1996. The study was designed to test the safety of the drug by comparing it with a placebo.

Dr. Mark O'Hollaren, a Portland allergist and a nationally known asthma expert, said he's worried that patients who are taking a combination of Serevent and inhaled steroids might stop taking the steroids.

"Our phones are already ringing about it," he said.

Taken by itself, Serevent may seem to control symptoms of asthma. But without inhaled steroids, he said, "the underlying inflammatory process is still there."

The Glaxo study found that African Americans were more likely than whites to have serious asthma-related illness and death while using Serevent. African Americans, who made up 17 percent of the 25,858 participants in the study, were likely to have more severe asthma than whites when they entered the study, and they were less likely than whites to use inhaled corticosteroids as a routine part of their treatment.

The study found no differences in the safety of Serevent and the placebo in whites.

O'Hollaren, chairman of the section on asthma, rhinitis and respiratory diseases of the American Academy of Asthma, Allergy and Immunology, said that nationally, African Americans have more difficulty with asthma probably for a number of reasons.

"Poverty and access to care seem to be part of the explanation," he said. "But there appear to be differences, possibly on a genetic basis, that are separate from socioeconomic status."

Dr. Fred Gill, chief of Kaiser Permanente Northwest's allergy/immunology department, estimated that 3,000 to 5,000 of Kaiser's 500,000 patients in Oregon and Southwest Washington use Serevent.

A major concern with using Serevent alone is that it could mask a progressive worsening of the disease, Gill said. The drug could keep a person's airways open while inflammation continued unabated.

O'Hollaren said the Serevent study should remind asthma patients that they should not rely only on either slow-acting Serevent or fast-acting "rescue" bronchodilators containing albuterol to treat their symptoms.

Other studies have shown that asthma patients consistently underestimate the severity of their disease.

"They may say, 'I only need to use my (fast-acting) inhaler once a day, so I only have mild asthma,' " O'Hollaren said. But under newly revised criteria from the National Institutes of Health, once-a-day use indicates severe, persistent asthma.

The allergist said people who are using Serevent alone should contact their doctors. Those using Serevent along with steroids should continue using the drug, he said.

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