Efficacy and tolerability of 5-day, once-daily telithromycin compared with 10-day, twice-daily clarithromycin for the treatment of group A beta-hemolytic streptococcal tonsillitis/pharyngitis: a multicenter, randomized, double-blind, parallel-group s

摘要

BACKGROUND: Telithromycin, a ketolide antibacterial, has been developed for the treatment of community-acquired respiratory infections. OBJECTIVE: This study compared the efficacy and tolerability of 5-day, once-daily telithromycin with 10-day, twice-daily clarithromycin in adolescents and adults with acute tonsillitis/pharyngitis caused by group A beta-hemolytic streptococci ([GABHS] Streptococcus pyogenes). METHODS: In this multicenter, randomized, double-blind, parallel-group study, adolescent (aged > or = 13 years) and adult patients with a diagnosis of GABHS tonsillitis/pharyngitis received once-daily telithromycin 800 mg for 5 days (followed by placebo for 5 days) or twice-daily clarithromycin 250 mg for 10 days. Bacteriologic and clinical outcomes were assessed at a test-of-cure visit (days 16 to 23) and a late posttherapy visit (days 31 to 45). RESULTS: A total of 526 patients were enrolled in the study, of which 463 (288 females, 175 males) were randomized to receive treatment (telithromycin, n = 232; clarithromycin, n = 231). The mean age of the telithromycin group was 30.9 years; in the clarithromycin group, it was 30.0 years. Bacterial eradication was achieved in 91.3% of telithromycin-treated patients and 88.1% of clarithromycin recipients (difference, 3.2%; 95% CI, -4.5 to 11.0). Clinical cure was achieved in 92.7% of telithromycin recipients and 91.1% of clarithromycin-treated patients (difference, 1.6%; 95% CI, -5.5 to 8.6). Bacteriologic and clinical cures for the 2 treatment groups also were similar at the late posttherapy visit. Treatment-related adverse events occurred more frequently in the telithromycin group than the clarithromycin group (67.2% vs 57.5%, respectively); diarrhea, nausea, and vomiting were significantly more common with telithromycin than with clarithromycin (P = 0.004, 0.010, and 0.001, respectively). Adverse events were generally mild. CONCLUSION: This study demonstrates that telithromycin 800 mg once daily for 5 days was an effective and generally well-tolerated treatment for tonsillitis/pharyngitis caused by GABHS, providing similar bacteriologic and clinical efficacy to clarithromycin 250 mg twice daily for 10 days in the per-protocol population.