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A widely used two-drug treatment for asthma is safe and effective, according to a large study involving a UW-Madison doctor prompted by concerns about deaths from one of the drugs.
Roughly half of the 25 million Americans with asthma take a corticosteroid and a long-acting beta agonist, typically together in one inhaler, to breathe more easily.
Earlier studies found deaths and other serious side effects in patients on long-acting beta agonists, or LABAs, prompting the Food and Drug Administration to require warnings on packages. But many doctors continued prescribing the drugs, typically with inhaled corticosteroids, because they seemed to help.
Now, a major study by LABA manufacturers, ordered by the FDA, has found the two types of drugs together are as safe as corticosteroids alone — and more effective. That led the FDA to remove the warning, a rare occurrence.
“It affirms the safety of an effective asthma treatment, a very common treatment,” said Dr. William Busse, a UW allergist and pulmonologist who is lead author of a report on the findings published Thursday in the New England Journal of Medicine. “That’s very reassuring, primarily to the patients but also to the physicians prescribing.”
Corticosteroids reduce inflammation, and LABAs dilate airways, both helpful to people with asthma. Studies showing side effects from LABAs raised concerns but didn’t determine conclusively if the drugs were safe or not, Busse said.
The new study, started in 2010, involved more than 36,000 patients, including 25 at UW Health. Half took corticosteroids only, and the other half took both drugs.
Among patients on combination therapy, 119 had serious side effects. Among those who took only corticosteroids, 108 had serious side effects, a statistical tie.
Only 9.8 percent of patients on both drugs had asthma attacks, compared to 11.7 percent on just corticosteroids, making the combination significantly more effective.
The findings are convincing because the study was so large, Busse said. “I think the question has been resolved as much as one can do it,” he said.
Meanwhile, other UW researchers had a report in the same edition of the New England Journal of Medicine.
Dr. Amy Kind, who specializes in geriatrics, and health geographer William Buckingham wrote about an online map they designed that shows how advantaged or disadvantaged each neighborhood is around the country.
The goal is to help researchers, policy makers and doctors become more aware that neighborhoods vary in factors such as housing, unemployment, poverty and education level. The data is provided by ZIP code.
“If health interventions or policies don’t take into account these contextual factors — these issues of neighborhood disadvantage — they may be less effective,” Kind said.
Doctors treating patients with diabetes should think about whether the patients have refrigerators, for example. “If they don’t have a refrigerator to keep their insulin active and safe and useful, all the education in the world is probably not going to be enough to improve their diabetes control,” Kind said.
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