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Azithromycin Microspheres and Levofloxacin Equally Effective in COPD: Presented at ATS

By Jill Stein

SAN DIEGO, C.A. -- May 22, 2006 -- Single-dose azithromycin-microspheres (AZ-M) and 7-day levofloxacin (LEV) are equally effective treatments for acute exacerbation of chronic bronchitis (AECB) without regard to underlying severity of chronic obstructive pulmonary disease (COPD), it was announced here at the American Thoracic Society International Conference (ATS).

Findings were presented from a post-hoc analysis of a phase 3, multicenter, double-blind, double-dummy study of AZ-M (2-g single dose) versus LEV (500 mg daily for 7 days) in patients with AECB. The results were explained by Marcus Zervos, MD, director, infectious diseases division, Henry Ford Health System and Wayne State University School of Medicine, Detroit, Michigan.

The analysis, said Dr. Zervos, included patients who had a history of chronic bronchitis (defined as chronic cough and sputum production on most days for 3 consecutive months for at least 2 consecutive years) and current evidence of AECB.

Overall, 153 of 268 patients (57%) in the AZ-M arm of the trial had a ratio of forced expiratory volume in 1 second divided by forced vital capacity (FEV₁/FVC) < 70. An identical percent of subjects in the LEV arm --157 of 274 (57%) -- had an FEV₁/FVC ratio < 70.

Demographic characteristics were similar in the 2 treatment arms.

Clinical responses for AZ-M and LEV were similar when subjects with a FEV₁/FVC < 70 and those with mild AECB were excluded from the analysis.

Over 89% of AZ-M subjects experienced clinical cure in the modified intent-to-treat population regardless of disease severity. For LEV subjects, over 81% experienced clinical cure. Results in the clinical per-protocol population were similar to those observed in the modified intent-to-treat population.

Compliance was 100% for AZ-M and 95% for LEV. Noncompliance was associated with treatment failure, deterioration in the patient's condition, and increased use of health-care resources.

Treatment-related adverse events were mild to moderate in intensity, and occurred in 22% of AZ-M and 15% of LEV patients.

Overall, the results demonstrate that AZ-M is effective in AECB irrespective of underlying COPD severity, said Dr. Zervos.

This study was sponsored by Pfizer, New London, Connecticut, United States.


[Presentation Title: Azithromycin Microspheres (AZ-M) Are as Effective as Levofloxacin (LEV) in Subjects With Moderate to Very Severe COPD. Abstract J78]

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