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Azithromycin in patients with cystic fibrosis chronically infected with Pseudomonas aeruginosa: a randomized controlled trial.

Abstract

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 (> or =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 > or =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 FEV1 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 =.009). Nausea occurred in 17% more participants 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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  • Authors+Show Affiliations

    ,

    Department of Pediatrics, Columbia University College of Physicians and Surgeons, New York, NY 10032-3784, USA. ls5@columbia.edu

    , , , , , , , , ,

    Source

    JAMA 290:13 2003 Oct 01 pg 1749-56

    MeSH

    Adolescent
    Anti-Bacterial Agents
    Azithromycin
    Child
    Chronic Disease
    Cystic Fibrosis
    Double-Blind Method
    Female
    Forced Expiratory Flow Rates
    Hospitalization
    Humans
    Interleukin-8
    Male
    Pancreatic Elastase
    Proportional Hazards Models
    Pseudomonas Infections
    Quality of Life
    Treatment Outcome

    Pub Type(s)

    Clinical Trial
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    14519709

    Citation

    Saiman, Lisa, et al. "Azithromycin in Patients With Cystic Fibrosis Chronically Infected With Pseudomonas Aeruginosa: a Randomized Controlled Trial." JAMA, vol. 290, no. 13, 2003, pp. 1749-56.
    Saiman L, Marshall BC, Mayer-Hamblett N, et al. Azithromycin in patients with cystic fibrosis chronically infected with Pseudomonas aeruginosa: a randomized controlled trial. JAMA. 2003;290(13):1749-56.
    Saiman, L., Marshall, B. C., Mayer-Hamblett, N., Burns, J. L., Quittner, A. L., Cibene, D. A., ... Campbell, P. W. (2003). Azithromycin in patients with cystic fibrosis chronically infected with Pseudomonas aeruginosa: a randomized controlled trial. JAMA, 290(13), pp. 1749-56.
    Saiman L, et al. Azithromycin in Patients With Cystic Fibrosis Chronically Infected With Pseudomonas Aeruginosa: a Randomized Controlled Trial. JAMA. 2003 Oct 1;290(13):1749-56. PubMed PMID: 14519709.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Azithromycin in patients with cystic fibrosis chronically infected with Pseudomonas aeruginosa: 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,3rd AU - ,, PY - 2003/10/2/pubmed PY - 2003/10/8/medline PY - 2003/10/2/entrez SP - 1749 EP - 56 JF - JAMA JO - JAMA VL - 290 IS - 13 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 (> or =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 > or =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 FEV1 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 =.009). Nausea occurred in 17% more participants 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. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/14519709/full_citation L2 - https://jamanetwork.com/journals/jama/fullarticle/vol/290/pg/1749 DB - PRIME DP - Unbound Medicine ER -