WebMD Medical News
Laura J. Martin, MD
Aug. 23, 2011 -- A common antibiotic, taken for a year, reduced the number of flare-ups in patients with the lung disease known as COPD (chronic obstructive pulmonary disease), according to new research.
''In patients with COPD at high risk for flare-ups, the addition of daily azithromycin for one year reduced the frequency of those events," says researcher Mark Dransfield, MD, director of the University of Alabama at Birmingham Lung Health Center.
COPD is most often caused by smoking. Patients find it difficult to breathe as the disease progresses. They get infections more often, which leads to even more shortness of breath, Dransfield tells WebMD.
"A typical person with moderate to severe COPD gets one to three of these flare-ups each year," he says.
The regimen reduced flare-ups by about 20%, he says.
At least 13 million U.S. adults have COPD.
Minimizing the flare-ups can reduce hospitalizations and improve quality of life, he says. However, some of the side effects of long-term antibiotic use are of concern, he says.
The study is published in The New England Journal of Medicine. The study was funded by the National Institutes of Health.
Dransfield assigned 570 patients with COPD to take 250 milligrams of azithromycin daily for a year. He assigned 572 others to a placebo pill that looked the same.
About 80% of the patients were also on other medications for COPD. Both groups continued taking other medications, including inhaled steroids and bronchodilators.
COPD can include chronic bronchitis (which involves a chronic cough with mucus) or emphysema (which involves damage to the lungs), or both.
Typically, a patient with COPD who has a flare-up is given a course of antibiotics, but not long-term, Dransfield says.
The researchers decided to look at the long-term treatment because similar regimens have shown promise in other lung diseases, including cystic fibrosis.
Patients were on average aged 65. ''To get into the study, you had to be on oxygen or reported having one of these flare-ups in the previous year,'' Dransfield says.
Compared to placebo, the antibiotic reduced flare-ups by about 20%. At the one-year mark, those in the placebo group had on average 1.83 flare-ups, but those in the antibiotic group had 1.48.
During the study, there were 156 hospitalizations for COPD for the antibiotic group and 200 for the placebo group.
The antibiotic is available generically, Dransfield says. It costs about a dollar a pill.
The regimen had downsides, he tells WebMD. One was hearing loss, which has been found with other antibiotics as well, he says. "We did see a small percent of people with hearing loss, but the differences between drug and placebo was not dramatic," he says. Although 25% of those on medication had a hearing decline when tested, 20% of those on placebo did.
The medicine also increased the amount of antibiotic-resistant microbes in some patients. However, no one got an infection related to that during the study.
Dransfield says the regimen would only be meant for those with moderate to severe COPD who require supplemental oxygen or who have a history of flare-ups.
''If you are in the ER a couple times a year or the hospital once a year and have frequent flare-ups, more than twice a year, I think the benefits outweigh the risks here," he says.
Patients who have heart problems linked with abnormal rhythms are not good candidates for the long-term therapy, he says.
Dransfield reports consulting and speaking fees for GlaxoSmithKline, Boehringer Ingelheim, and Forest Pharmaceuticals.
''It looks like it reduces exacerbations of COPD, and that is a good thing," says Norman Edelman, MD, chief medical officer for the American Lung Association, He reviewed the study findings but was not involved in the research. He is also professor of preventive and internal medicine at Stony Brook School of Medicine.
The fewer the flare-ups, he says, the fewer hospitalizations, and the better the quality of life.
In general, ''the more exacerbations, the more rapidly the underlying severity of the disease progresses,'' Edelman says.
However, he had some caveats about the research. "One is the hearing issue," he says.
The other issue is finding out how much you are changing the microbe population of the lung long-term, Edelman says. That could lead to antibiotic resistance.
For now, his best advice for COPD patients who think the new treatment would help is to talk to their doctor. "Make sure he has read the study," Edelman says.
SOURCES:Mark Dransfield, MD, director, University of Alabama at Birmingham Lung Health Center; associate professor of pulmonary, allergy, and critical care medicine.Albert, R. The New England Journal of Medicine, Aug. 25, 2011; vol 365: pp 689-698.Siafakas, N. The New England Journal of Medicine, Aug. 25, 2011; vol 365: pp 753-754.Norman Edelman, MD, chief medical officer, American Lung Association; professor of preventive and internal medicine, Stony Brook School of Medicine, Stony Brook, N.Y.
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