Key News in Family Medicine May 03, 2019 (2 of 3)

Azithromycin, an antibiotic, may reduce treatment failure in hospitalized patients for acute exacerbation of chronic obstructive pulmonary disease (COPD), according to a randomized controlled trial published online in the American Thoracic Society. American Journal of Respiratory and Critical Care Medicine.

In "Azithromycin during acute exacerbations of COPD requiring hospitalization (BACE): a multicentre, randomized, double-blind, placebo-controlled trial," Belgian researchers announced the addition from a low dose of azithromycin to the prescribed drugs during their stay in the hospital. A low dose of antibiotic for 3 months after hospitalization reduced treatment failure compared with standard treatment. The researchers defined the failure of treatment as the need to intensify treatment with systemic steroids and / or antibiotics, to transfer the patient to the intensive care unit or to readmit him to the patient. hospital after discharge and death, whatever the cause.

Previous studies have shown that azithromycin prevents acute exacerbations of COPD, but it was difficult to determine whether it was necessary to intensify the care of hospitalized patients for an exacerbation or d? improve their chances of not having another exacerbation after leaving the hospital.

Wim Jannssens, MD, Ph.D., lead author of the study, professor of medicine at KU Leuven and pulmonologist at Leuven University Hospitals, said the goal of the study was to check if the goal was to target the highest-risk patients for a limited period. The widespread use of azithromycin as a chronic preventative therapy for COPD exacerbations has been beneficial for patients.

"We wanted to establish a new treatment option for acute exacerbations with hospitalization, as current treatments are clearly inadequate," he added. "Equally important, we wanted to see if the continuation of azithromycin for a relatively short period after leaving the hospital could interrupt the vicious cycle of relapses even after stopping treatment."

The study included 301 patients in 20 Belgian hospitals. Azithromycin was administered to half of the patients, the other half to a placebo, in addition to the medications that their doctor would normally prescribe to resolve the exacerbation. Patients in the azithromycin group of the study received 500 mg / day for 3 days during their hospitalization, then 250 mg twice a week for 3 months after leaving the hospital.

The study found that treatment failure rates were 49% for patients in the azithromycin group and 60% for those in the placebo group. Given that the researchers did not reach their target of 500 participants, the trial was not powerful enough to demonstrate the statistical significance of its primary endpoint: the time to failure of treatment.

People receiving the antibiotic spent 24% less days in the hospital and 74% fewer days in the USI than those taking the placebo. Mortality among patients in the azithromycin group was half that of the placebo group: 2% vs. 4%. These benefits appeared more pronounced in non-smokers. Current smokers have little or no benefit from low dose azithromycin.

The researchers also investigated the effects of azithromycin withdrawal after 3 months and found that 6 months later, the clinical benefits of the antibiotic were lost.

Although the study can not prove the statistical significance of its primary endpoint, "the positive message from the trial is that our strategy has reduced the length of hospital stay, the number of days in ICU, and the recurrent exacerbations in the most serious group of COPD, "said Dr. Janssens, adding that a large phase 4 study with readmission to the hospital as the primary endpoint would be needed before large-scale implementation of results of this study.