TY - JOUR
T1 - Azithromycin in Patients with Cystic Fibrosis Chronically Infected with Pseudomonas aeruginosa
T2 - A Randomized Controlled Trial
AU - Saiman, Lisa
AU - Marshall, Bruce C.
AU - Mayer-Hamblett, Nicole
AU - Burns, Jane L.
AU - Quittner, Alexandra L.
AU - Cibene, Debra A.
AU - Coquillette, Sarah
AU - Fieberg, Ann Yunker
AU - Accurso, Frank J.
AU - Campbell, Preston W.
N1 - Copyright:
Copyright 2008 Elsevier B.V., All rights reserved.
PY - 2003/10/1
Y1 - 2003/10/1
N2 - Context: Treatment strategies for cystic fibrosis (CF) lung disease include antibiotics, mucolytics, and anti-inflammatory therapies. Increasing evidence suggests that macrolide antibiotics might be beneficial in patients with CF. Objective: To determine if an association between azithromycin use and pulmonary function exists in patients with CF. Design and Setting: A multicenter, randomized, double-blind, placebo-controlled trial conducted from December 15, 2000, to May 2, 2002, at 23 CF care centers in the United States. Participants: Of the 251 screened participants with a diagnosis of CF, 185 (74%) were randomized. Eligibility criteria included age 6 years or older, infection with Pseudomonas aeruginosa for 1 or more years, and a forced expiratory volume in 1 second (FEV1) of 30% or more. Participants were stratified by FEV1 (≥60% predicted vs <60% predicted), weight of less than 40 kg vs 40 kg or more, and CF center. Intervention: The active group (n = 87) received 250 mg (weight <40 kg) or 500 mg (weight ≥40 kg) of oral azithromycin 3 days a week for 168 days; placebo group (n = 98) received identically packaged tablets. Main Outcome Measures: Change in FEV1 from day 0 to completion of therapy at day 168 and determination of safety. Secondary outcomes included pulmonary exacerbations and weight gain. Results: The azithromycin group had a mean 0.097-L (SD, 0.26) increase in FEV 1 at day 168 compared with 0.003 L (SD, 0.23) in the placebo group (mean difference, 0.094 L; 95% confidence interval [CI], 0.023-0.165; P = .09). Nausea occurred in 17% more participatns in the azithromycin group (P = .01), diarrhea in 15% more (P = .009), and wheezing in 13% more (P = .007). Participants in the azithromycin group had less risk of experiencing an exacerbation than participants in the placebo group (hazard ratio, 0.65; 95% CI, 0.44-0.95; P = .03) and weighed at the end] of the study an average 0.7 kg more than participants receiving placebo (95% CI, 0.1-1.4 kg; P = .02). Conclusion: Azithromycin treatment was associated with improvement in clinically relevant end points and should be considered for patients with CF who are 6 years or older and chronically infected with P aeruginosa.
AB - Context: Treatment strategies for cystic fibrosis (CF) lung disease include antibiotics, mucolytics, and anti-inflammatory therapies. Increasing evidence suggests that macrolide antibiotics might be beneficial in patients with CF. Objective: To determine if an association between azithromycin use and pulmonary function exists in patients with CF. Design and Setting: A multicenter, randomized, double-blind, placebo-controlled trial conducted from December 15, 2000, to May 2, 2002, at 23 CF care centers in the United States. Participants: Of the 251 screened participants with a diagnosis of CF, 185 (74%) were randomized. Eligibility criteria included age 6 years or older, infection with Pseudomonas aeruginosa for 1 or more years, and a forced expiratory volume in 1 second (FEV1) of 30% or more. Participants were stratified by FEV1 (≥60% predicted vs <60% predicted), weight of less than 40 kg vs 40 kg or more, and CF center. Intervention: The active group (n = 87) received 250 mg (weight <40 kg) or 500 mg (weight ≥40 kg) of oral azithromycin 3 days a week for 168 days; placebo group (n = 98) received identically packaged tablets. Main Outcome Measures: Change in FEV1 from day 0 to completion of therapy at day 168 and determination of safety. Secondary outcomes included pulmonary exacerbations and weight gain. Results: The azithromycin group had a mean 0.097-L (SD, 0.26) increase in FEV 1 at day 168 compared with 0.003 L (SD, 0.23) in the placebo group (mean difference, 0.094 L; 95% confidence interval [CI], 0.023-0.165; P = .09). Nausea occurred in 17% more participatns in the azithromycin group (P = .01), diarrhea in 15% more (P = .009), and wheezing in 13% more (P = .007). Participants in the azithromycin group had less risk of experiencing an exacerbation than participants in the placebo group (hazard ratio, 0.65; 95% CI, 0.44-0.95; P = .03) and weighed at the end] of the study an average 0.7 kg more than participants receiving placebo (95% CI, 0.1-1.4 kg; P = .02). Conclusion: Azithromycin treatment was associated with improvement in clinically relevant end points and should be considered for patients with CF who are 6 years or older and chronically infected with P aeruginosa.
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U2 - 10.1001/jama.290.13.1749
DO - 10.1001/jama.290.13.1749
M3 - Article
C2 - 14519709
AN - SCOPUS:0141816759
VL - 290
SP - 1749
EP - 1756
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
SN - 0002-9955
IS - 13
ER -