Purple does not stand for prevention in asthma

The so-called purple pill, known popularly as Nexium and and esomeprazole to physicians, did not reduce asthma symptoms in patients who did not have symptoms of heartburn, said researchers, including one from Baylor College of Medicine, in a report that appears today in The New England Journal of Medicine.

"I was surprised," said Dr. Nicola Hanania, associate professor of medicine – pulmonary, at BCM. "It was disappointing for us, but that is why we do research." Hanania is principal investigator at the BCM site.

He emphasized that the result of this study apply only to people with asthma who do not have symptoms of heartburn. For at least two decades, physicians have prescribed proton pump inhibitors (drugs that block the production of gastric acid) for patients with poorly controlled asthma, whether they had symptoms of heartburn or not. They believed that acid reflux, whether recognized or not, could be trigger some asthma symptoms such as wheezing, coughing or breathlessness.

Now a 20-center study involving 402 patients with asthma poorly controlled on the usual drugs shows that such treatment has no effect. The patients were randomly assigned to one of two groups. One group took 40 milligrams of the heartburn drug twice daily for six months. The others took an inactive pill called placebo.

Members of each group had the same number of episodes of poor asthma control during that period, indicating the heartburn medicine had no effect on improving asthma control.

About half the patients had a positive test for excess acid in their gastrointestinal tract when tested with a special probe, which indicates they might have reflux, said Hanania. However, even in these patients, the heartburn drugs appeared to have no effect.

"Each year, people with asthma are spending as much as $10 million dollars on prescription heartburn medication believing it will help control attacks of wheezing, coughing and breathlessness," said Norman H. Edelman, MD, American Lung Association chief medical officer. "Now we know with confidence that silent acid reflux does not play a significant role in poor asthma control. Talk with your doctor before discontinuing any medication, as each patient's specific needs will vary."

A study of the effect of these drugs in children is currently underway, Hanania said. Asthma appears to affect children differently, and the researchers feel that study should continue.

The study demonstrates the benefit of the Asthma Clinical Research Centers, a 20-center network that works together to test treatments and answer common questions related to this disease, said Hanania.

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Funding for this work came from the National Heart, Lung and Blood Institute, the American Lung Association and Astra/Zeneca (Nexium's maker that provided the drug).

After the embargo lifts, this report will be available at www.nejm.org.