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Randomized Controlled Trial
. 2011 Aug 25;365(8):689-98.
doi: 10.1056/NEJMoa1104623.

Azithromycin for prevention of exacerbations of COPD

Richard K Albert  1 , John Connett, William C Bailey, Richard Casaburi, J Allen D Cooper Jr, Gerard J Criner, Jeffrey L Curtis, Mark T Dransfield, Meilan K Han, Stephen C Lazarus, Barry Make, Nathaniel Marchetti, Fernando J Martinez, Nancy E Madinger, Charlene McEvoy, Dennis E Niewoehner, Janos Porsasz, Connie S Price, John Reilly, Paul D Scanlon, Frank C Sciurba, Steven M Scharf, George R Washko, Prescott G Woodruff, Nicholas R Anthonisen; COPD Clinical Research Network
Collaborators, Affiliations
Randomized Controlled Trial

Azithromycin for prevention of exacerbations of COPD

Richard K Albert et al. N Engl J Med. .

Erratum in

  • N Engl J Med. 2012 Apr 5;366(14):1356

Abstract

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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Conflict of interest statement

No other potential conflict of interest relevant to this article was reported.

Figures

Figure 1
Figure 1. Screening, Randomization, and Follow-up
Patients who completed the 12-month course of the study drug were asked to return 1 month later for a washout visit. FEV1 denotes forced expiratory volume in 1 second, and FVC forced vital capacity.
Figure 2
Figure 2. Proportion of Participants Free from Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) for 1 Year, According to Study Group
The analyses were based on the participants who were randomly assigned to the group minus those who did not return for any follow-up assessment — 558 participants in the azithromycin group, of whom 317 (57%) had an acute exacerbation, and 559 in the placebo group, of whom 380 (68%) had an acute exacerbation.
Figure 3
Figure 3. Rates of Acute Exacerbations of Chronic Obstructive Pulmonary Disease per Person-Year, According to Study Group
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References

    1. Strassels SA, Smith DH, Sullivan SD, Mahajan PS. The costs of treating COPD in the United States. Chest. 2001;119:344–352. - PubMed
    1. Andersson F, Borg S, Jansson SA, et al. The costs of exacerbations in chronic obstructive pulmonary disease (COPD) Respir Med. 2002;96:700–708. - PubMed
    1. Druss BG, Marcus SC, Olfson M, Pincus HA. The most expensive medical conditions in America. Health Aff (Millwood) 2002;21:105–111. - PubMed
    1. Miller JD, Foster T, Boulanger L, et al. Direct costs of COPD in the U.S.: an analysis of Medical Expenditure Panel Survey (MEPS) data. COPD. 2005;2:311–318. - PubMed
    1. Lindenauer PK, Pekow P, Gao S, Crawford AS, Gutierrez B, Benjamin EM. Quality of care for patients hospitalized for acute exacerbations of chronic obstructive. 144:894–903. - PubMed

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