Journal
NEW ENGLAND JOURNAL OF MEDICINE
Volume 365, Issue 8, Pages 689-698Publisher
MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa1104623
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Funding
- National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health [U10 HL074407, U10 HL074408, U10 HL074409, U10 HL074416, U10 HL074418, U10 HL074422, U10 HL074424, U10 HL074428, U10 HL074431, U10 HL074439, U10 HL074441]
- Division of Lung Diseases of the NHLBI
- National Center for Research Resources [M01]
- Gilead Sciences
- Elsevier
- Novartis Pharmaceuticals
- Forest Pharmaceuticals
- Theratechnologies
- Breathe Technologies
- Medtronic Spinal and Biologics
- Boehringer Ingelheim
- Philips Respironics
- Novartis
- Actelion Pharmaceuticals
- AstraZeneca
- Pfizer
- Roche
- Osiris Therapeutics
- GlaxoSmithKline
- Watkins
- Louri
- Roll and Change
- Lawrence R. Dry Associates
- Starnes Davis Florie LLP
- Walker
- Tipps Malone PLC
- Moore
- Ingram Johnson Steele
- Farris
- Riley Pitt, LLP
- Phillips Pharmaceuticals
- Uptake Medical
- Dey
- Boston Scientific
- CSL Behring
- Astellas Pharma
- Talecris Biotherapeutics
- Chiesi Pharmaceuticals
- MedImmune-Astra Zeneca
- Merck
- Pearl Therapeutics
- UBC
- Mpex Pharmaceuticals and Ikaria
- Forest-Almirall
- Nycomed-Forest
- Bayer
- Schering-Plough (Merck)
- HLS
- Comgeniz
- fb Communications
- BoomComm
- Elan
- Genzyme
- Quark Pharmaceuticals
- Sanofi-Aventis
- Associates in Medical Marketing and Castle Connolly
- National Association for Continuing Education
- Med-Ed
- Potomac Pharma
- Vox Medica
- WebMD
- Epocrates
- Altana-Nycomed
- Global
- Johnson & Johnson-Centocor Ortho Biotech
- MicroPhage
- Cubist Pharmaceuticals
- Quintiles
- Sanofi Pasteur
- BioCryst Pharmaceuticals
- Accelr8 Technology
- Robert Michael
- Baxter Healthcare
- Altana
- Lippincott Williams Wilkins
- Wolters Kluwer
- Genentech
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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.)
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