2003 OPEN FORUM Abstracts
3-DAY AZITHROMYCIN (AZM) VS. 5-DAY MOXIFLOXACIN (MOX) IN OUTPATIENTS (OP) WITH AECB
Marcus Zervos, MD,1 Guy W. Amsden, PharmD, FCP,2 Fernando J. Martinez, MD3, Naumann Chaudry, PharmD, 4 William Beaumont Hospital, Royal Oak, MI;1 Bassett Healthcare, Cooperstown, NY;2 University of Michigan Medical Center, Ann Arbor, MI3, Pfizer, Inc., New York, NY4.
Background: This study was done to compare the efficacy and safety of 2 recently approved short, once-daily therapies for AECB.
Methods: Randomized, investigator blinded, multicenter study evaluated PO AZM 500mg qd x 3 days and PO MOX 400mg qd x 5 days in OPs aged 40-75 with AECB clinical diagnosis (FEV1>35%). Cultures obtained at baseline by sputum collection. Clinical responses of subjects assessed by investigators at End-of-Therapy (EOT; Day 11) and End-of-Study (EOS; Day 24) visits. Comparison was via 2-sided 95% CI of treatment difference (AZM-MOX) in clinical successes. Lower limit of >-10% established non-inferiority. Clinical success rates at EOS were the primary endpoint.
RESULTS: Total of 342 treated (intent-to-treat [ITT]: 169 AZM; 173 MOX). Clinical success rates demonstrated AZM was as effective as MOX in both clinically evaluable (CE) and ITT subjects (see table):
|EOT CE EOT ITT||136/153 (88.9%) 147/164 (89.6%)||136/152 (89.5%) 149/165 (90.3%)||-7.6%, 6.4% -7.2%, 5.8%|
|EOS CE EOS ITT||125/156 (80.1%) 133/164 (81.1%)||121/150 (80.7%) 132/162 (81.5%)||-9.5%, 8.4% -8.9%, 8.1%|
Bacteriologic success rates in AZM and MOX ITT subjects with baseline pathogen (S. pneumoniae, H. influenzae, M. catarrhalis, H. parainfluenzae) at EOT were 89.4% and 84.5% and at EOS were 91.3% and 72.7%, respectively. Incidence of at least one treatment-related adverse event was 18.3% in AZM and 19.1% in MOX. Most were digestive in nature.
Conclusions: PO AZM 500mg qd X 3 days was as clinically and bacteriologically effective with similar safety profile as PO MOX 400mg qd X 5 days in OPs with AECB.