Daily azithromycin plus treatment decreased COPD exacerbations, improved QOL

August 31, 2011

When added to usual treatment, azithromycin taken daily for 1 year decreased the frequency of chronic obstructive pulmonary disease (COPD) exacerbations and improved quality of life among patients, reported a study published August 25 in the New England Journal of Medicine.

When added to usual treatment, azithromycin taken daily for 1 year decreased the frequency of chronic obstructive pulmonary disease (COPD) exacerbations and improved quality of life among patients, reported a study published August 25 in the New England Journal of Medicine. However, a small percentage of patients experienced hearing decrements.

Because macrolide antibiotics benefit patients with a variety of inflammatory airway diseases, researchers conducted a randomized trial to assess the efficacy of azithromycin at decreasing the frequency of exacerbations in patients with COPD.

A total of 1,142 patients who were at least 40 years of age and had a clinical diagnosis of COPD with an increased risk of exacerbations but no hearing impairment, resting tachycardia, or apparent risk of prolongation of the corrected QT interval were randomly assigned to receive azithromycin 250 mg daily (570 participants) or placebo (572 participants) for 1 year in addition to their usual care.

The primary outcome was the time to the first acute exacerbation of COPD. Secondary outcomes included nasopharyngeal colonization with selected respiratory pathogens (i.e., Staphylococcus aureus, Streptococcus pneumoniae, haemophilus species, and moraxella species), and adherence to taking the study drug as prescribed.

The study indicated a decreased frequency in acute exacerbations for patients at increased risk for acute exacerbations of COPD who received azithromycin, at a dose of 250 mg once daily, for 1 year in addition to their usual care. This decrease was accompanied by a decrease in the incidence of colonization with selected respiratory pathogens and improved quality of life, but also an increase in the incidence of colonization with macrolide-resistant organisms and an excess rate of hearing decrements of approximately 5%, the researchers noted.

Among patients receiving azithromycin, the median time to the first exacerbation was 266 days (95% confidence interval [CI], 227 to 313) compared with 174 days (95% CI, 143 to 215) among patients in the placebo group (PP=0.01). To assess quality of life, patients were administered St. George’s Respiratory Questionnaire, for which lower scores on a scale of 0-100 indicated better functioning. Researchers noted that the azithromycin group’s scores improved more than those of the placebo group (a mean [±SD] decrease of 2.8±12.8 vs. 0.6±11.4, P=0.004). The percentage of participants with more than the minimal clinically important difference of -4 units was 43% in the azithromycin group compared with 36% in the placebo group (P=0.03). However, hearing decrements were more common in the azithromycin group than in the placebo group (25% vs. 20%, P=0.04).

“Given the deleterious effects of acute exacerbations of COPD with respect to the risk of death, quality of life, loss of lung function, and cost of care, adding azithromycin to the treatment regimen of patients who have had an acute exacerbation of COPD within the previous year or who require supplemental oxygen is a valuable option; however, the patients should be screened for the presence of QTc prolongation and the risk of QTc prolongation and their hearing should be monitored,” the authors wrote.