Telithromycin is as effective as amoxicillin/clavulanate in acute exacerbations of chronic bronchitis

• Published in: Respiratory medicine Vol. 96; no. 11; pp. 862 - 871
• Main Authors: AUBIER, M, ALDONS, P.M, LEAK, A, MCKEITH, D.D, LEROY, B, RANGARAJU, M, BIENFAIT-BEUZON, C
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01-11-2002; Elsevier
• Subjects: acute exacerbation of chronic bronchitis; Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination - adverse effects; Amoxicillin-Potassium Clavulanate Combination - therapeutic use; amoxicillin/clavulanate; Anti-Bacterial Agents - adverse effects; Anti-Bacterial Agents - therapeutic use; Antibacterial agents; Antibiotics. Antiinfectious agents. Antiparasitic agents; Biological and medical sciences; Bronchitis, Chronic - drug therapy; Bronchitis, Chronic - microbiology; chronic bronchitis; chronic obstructive pulmonary disease; Double-Blind Method; Drug Therapy, Combination - adverse effects; Drug Therapy, Combination - therapeutic use; Female; Humans; ketolide; Ketolides; Lung Diseases, Obstructive - drug therapy; Lung Diseases, Obstructive - microbiology; Macrolides; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; telithromycin (HMR 3647); Treatment Outcome; acute exacerbation of chronic bronchitis; chronic bronchitis; amoxicillin/clavulanate; telithromycin (HMR 3647); ketolide; chronic obstructive pulmonary disease; Human; Lung disease; Respiratory disease; Clavulanic acid; Treatment efficiency; β-Lactams; Telithromycin; Infection; Penicillin derivatives; Antibiotic; Chemotherapy; Chronic; Treatment; Amoxicillin; Bronchus disease; Complication; Bronchitis; Obstructive pulmonary disease; Aggravation
• ISSN: 0954-6111; 1532-3064
• DOI: 10.1053/rmed.2002.1382

This randomized, double-blind study evaluated the efficacy and safety of a short, 5-day course of telithromycin, a new ketolide antibacterial, compared with a standard 10-day course of amoxicillin/clavulanate, in the treatment of acute exacerbations of chronic bronchitis (AECB). The study enrolled 325 adult patients with AECB and a history of chronic obstructive pulmonary disease (COPD). Patients received either telithromycin 800mg once daily (qd) for 5 days (followed by placebo for 5 days) or amoxicillin/clavulanate 500/125mg three times daily (tid) for 10 days. Clinical cure rates for telithromycin post-therapy (Days 17–21, test-of-cure) and late post-therapy (Days 31–36) were 86.1 and 78.1%, respectively; 82.1 and 75.0% for amoxicillin/clavulanate. Excellent clinical cure rates were also observed for high-risk patients. Bacteriologic outcome was satisfactory for 69.2% of telithromycin recipients
vs 70.0% for amoxicillin/clavulanate recipients. Both treatments were generally well tolerated, although the frequency of drug-related adverse events was almost two-fold higher for amoxicillin/clavulanate (25.0
vs. 13.1%). Thus, a 5-day course of telithromycin 800mgqd is an effective and well-tolerated alternative to a standard 10-day course of amoxicillin/clavulanate 500/125mg tid for first-line empiric treatment of AECB in adults with COPD.