Azithromycin for Prevention of Exacerbations of COPD

By R. Albert, J. Connett, William C. Bailey, R. Casaburi, J. Cooper, Gerard J. Criner, J. Curtis, M. Dransfield, Meilan K. Han, Stephen C. Lazarus and 15 more. New England Journal of Medicine, 2011

1,140 citations recorded by the source corpus.

BACKGROUND Acute exacerbations adversely affect patients with chronic obstructive pulmonary disease (COPD). Macrolide antibiotics benefit patients with a variety of inflammatory airway diseases. METHODS We performed a randomized trial to determine whether azithromycin decreased the frequency of exacerbations in participants with COPD who had an increased risk of exacerbations but no hearing impairment, resting tachycardia, or apparent risk of prolongation of the corrected QT interval. RESULTS A total of 1577 subjects were screened; 1142 (72%) were randomly assigned to receive azithromycin, at a dose of 250 mg daily (570 participants), or placebo (572 participants) for 1 year in addition to their usual care. The rate of 1-year follow-up was 89% in the azithromycin group and 90% in the placebo group. The median time to the first exacerbation was 266 days (95% confidence interval [CI], 227 to 313) among participants receiving azithromycin, as compared with 174 days (95% CI, 143 to 215) among participants receiving placebo (P<0.001). The frequency of exacerbations was 1.48 exacerbations per patient-year in the azithromycin group, as compared with 1.83 per patient-year in the placebo group (P=0.01), and the hazard ratio for having an acute exacerbation of COPD per patient-year in the azithromycin group was 0.73 (95% CI, 0.63 to 0.84; P<0.001). The scores on the St. George’s Respiratory Questionnaire (on a scale of 0 to 100, with lower scores indicating better functioning) improved more in the azithromycin group than in 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, as compared with 36% in the placebo group (P=0.03). Hearing decrements were more common in the azithromycin group than in the placebo group (25% vs. 20%, P=0.04). CONCLUSIONS Among selected subjects with COPD, azithromycin taken daily for 1 year, when added to usual treatment, decreased the frequency of exacerbations and improved quality of life but caused hearing decrements in a small percentage of subjects. Although this intervention could change microbial resistance patterns, the effect of this change is not known. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00325897.)

Subfields: Epidemiology, Pulmonary and Respiratory Medicine

View Paper: https://www.semanticscholar.org/paper/014c521f3d65ca5a55f5cde2540a8e8b1fbd9ecb

How researchers see this paper

The researchers whose trusted networks rank it highest, strongest advocate first. Every researcher gets a different order.

In Epidemiology

J. Wedzicha

In Pulmonary and Respiratory Medicine

Citations in the corpus

Global Initiative for Chronic Obstructive Lung Disease 2023 Report: GOLD Executive Summary (2023, neutral): “For patients continuing to exacerbate despite therapy with LABA+LAMA+ICS or those who have an eosinophil count of <100 cells/μL, the addition of roflumilast (particularly in patients with chronic bronchitis and an FEV1 < 50% predicted) (93–95) or a macrolide (particularly in patients who are not cur”
Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease: the GOLD science committee report 2019 (2019, background): “Other options include the addition of roflumilast or azithromycin(45, 46).”
Biofilm-Related Infections: Bridging the Gap between Clinical Management and Fundamental Aspects of Recalcitrance toward Antibiotics (2014, background): “Nevertheless, recent data suggest that the chronic use of azithromycin might be associated with side effects, such as ototoxicity and an increased level of bacterial resistance (302, 303).”
Editorial: Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2023 Guidelines for COPD, Including COVID-19, Climate Change, and Air Pollution (2023, neutral): “В не давно проведенном исследовании при ежедневном при еме азитромицина отмечалась его эффективность в от ношении влияния на обострения как конечную точку ис следования, однако прием препарата не может быть ре комендован из за неблагоприятного соотношения предполагаемой пользы и побочных эффектов [2”
Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report. GOLD Executive Summary. (2017, background): “Azithromycin use showed a reduced exacerbation rate in former smokers only and was associated with an increased incidence of bacterial resistance and impaired hearing tests.(162) Pulse moxifloxacin therapy in patients with chronic bronchitis and frequent exacerbations does not reduce exacerbation ra”