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By Ed Susman, Contributing Writer, MedPage Today Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse PlannerNote that this study was published as an abstract and presented at a conference. These data and conclusions should be considered preliminary until published in a peer-reviewed journal.Long-term antibiotic treatment of patients with COPD may prolong the time it takes for the disease to exacerbate.Point out that the study provides the basis for a prospective study of chronic azithromycin therapy in the immediate postdischarge period to determine if it helps to prolong the time to the next hospitalization.PHILADELPHIA -- Long-term antibiotic treatment of patients with chronic obstructive pulmonary disease (COPD) may prolong the time it takes for the disease to exacerbate, researchers suggested here.
The time to the next respiratory hospitalization following the first respiratory-related hospitalization was significantly longer in COPD patients treated with azithromycin for a year than those given placebo (HR 0.58, 95% CI 0.34-0.99), according to Fernando Martinez, MD, director of pulmonary diagnostic services at the University of Michigan Health System in Ann Arbor.
The differences in re-hospitalization began after 40 days and continued to grow for 160 days before the effect began to wane, Martinez said at the American Thoracic Society meeting.
He demonstrated that at 40 days, about 90% of patients had avoided re-hospitalization in both the placebo and azithromycin groups; after 200 days, about 80% of patients treated with azithromycin had been free of respiratory-related re-hospitalization compared with about 60% of those on placebo.
"Also, looking at re-hospitalization due to any cause, we found there was a trend toward a delay between first and subsequent all-cause hospitalizations for patients taking azithromycin compared to those that did not take it," he said.
All patients who participated in the study either had experienced an acute exacerbation of COPD in the 12 months prior to study enrollment or had used supplemental oxygen at the time of enrollment. Patients were randomized to receive either a daily dose of 250 mg of azithromycin or placebo for one year.
The researchers observed that 45 azithromycin patients were re-hospitalized for any reason compared with 65 placebo patients (HR 0.71, 95% CI 0.47, 1.06).
"These are very preliminary results," Martinez told MedPage Today. He has plans to perform a prospective trial to definitively answer the question.
"Preventing respiratory-related re-hospitalizations is a key component of COPD therapy, and previous research has shown that a 12-month course of azithromycin decreases the risk of acute exacerbations of COPD," he said. "COPD patients who have been hospitalized for a respiratory event are at particularly high risk for re-hospitalization, and we wanted to examine whether chronic azithromycin therapy might provide a benefit in these patients."
Martinez explained that in the current healthcare environment "there is a keen interest in addressing the issue of how one can mitigate the risk of re-hospitalization in patients with COPD. ... In the U.S. that has been particularly driven by Medicare for penalizing institutions for re-hospitalization in a narrow period of time."
"There actually have been other studies -- not randomized -- looking at administrative databases that have demonstrated that time to the next exacerbation can be extended with the use of antibiotics," said David Mannino, MD, of the University of Kentucky in Lexington. "This study adds to that information," said Mannino, who moderated a press briefing on the study.
In a post-hoc analysis, the researchers observed that azithromycin-treated patients experienced 156 respiratory- related hospitalizations compared with 200 in placebo patients (HR 0.82, 95% CI 0.64-1.07). There were 31 patients on chronic azithromycin therapy who experienced a respiratory re-hospitalization, and 49 placebo patients who were re-hospitalized for respiratory conditions.
"It does raise the question of whether targeted use of a macrolide for a period of time after a hospitalization could have a beneficial effect by prolonging the time to the next event. That is a hypothesis that needs to be tested," Martinez said.
"This is an approach that is in evolution. We should not take away from this study that the dataset we explored validates this approach. The use of chronic antibiotics has to be used with care due to concerns about antibiotic resistance that occurs and because there can be adverse events with chronic antibiotic use. This is a very preliminary study."
Martinez disclosed commercial relationships with GlaxoSmithKline, Boehringer Ingelheim, Forrest, and Takeda.
Mannino disclosed commercial interests with GlaxoSmithKline, Pfizer, Novartis, AstraZeneca, MAP, Dey, Seprecor and Boehringer Ingelheim.
Primary source: American Thoracic Society International Conference
Source reference:
Martinez F, et al "Chronic azithromycin therapy decreases the risk of re-hospitalization in patients with COPD" ATS 2013; Abstract 40862.
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