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Published ahead of print on July 22, 2005, doi:10.1164/rccm.200502-218OC

Am. J. Respir. Crit. Care Med., Volume 172, Number 8, October 2005, 1008-1012

A more recent version of this article appeared on October 15, 2005
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Submitted on February 11, 2005
Accepted on July 21, 2005

Heterogeneity of Treatment Response to Azithromycin in Patients with Cystic Fibrosis

Lisa Saiman1*, Nicole Mayer-Hamblett2, Preston Campbell3, and Bruce C Marshall3

1 Department of Pediatrics, Columbia University, New York, NY, USA, 2 Department of Pediatrics, University of Washington, Seattle, WA, USA; Statistical Analysis Unit, Cystic Fibrosis Therapeutics Development Network Coordinating Center, Seattle, WA, USA, 3 Cystic Fibrosis Foundation, Bethesda, MD, USA

* To whom correspondence should be addressed. E-mail: ls5{at}columbia.edu.

Rationale: We recently reported a randomized, placebo-controlled trial of azithromycin in patients with cystic fibrosis (CF) that demonstrated a 6.2% improvement in the 168-day relative change in forced expiratory volume in one second (FEV1) among azithromycin participants compared to placebo participants. Objectives: In the current analyses, heterogeneity of treatment response and the association between FEV1 and the risk of pulmonary exacerbations were investigated. Methods: The time to first pulmonary exacerbation, hospitalization rates, and antibiotic use were compared between participants categorized by their relative change in FEV1% predicted (≥ 5% vs. < 5% improvement) at Day 168. Pulmonary function and exacerbation responses were compared in subgroups of participants characterized by long-term concomitant medications and baseline lung function. Measurements: All available data from the 185 randomized participants in the azithromycin trial were included in these analyses. Main Results: Compared to placebo participants, a reduced risk of pulmonary exacerbations was observed both among azithromycin participants with ≥5% and those with < 5% relative improvement in FEV1. Similarly, decreased hospitalization rates and decreased use of oral quinolone and non-quinolone antibiotics were observed in azithromycin participants regardless of improvement in FEV1. Subgroup analyses demonstrated that overall, participants on long-term aerosolized tobramycin and/or rhDNase had worse baseline lung function, but still benefited from azithromycin as evidenced by a lower risk of exacerbations. Conclusions: Azithromycin participants experienced benefits in exacerbation parameters regardless of FEV1 response or subgroup. These data have implications for clinical practice and the design of clinical trials.
Key words: Azithromycin, macrolide, antibiotic, cystic fibrosis, Pseudomonas aeruginosa




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