Clinical efficacy and time to symptom resolution of 5-day telithromycin versus 10-day amoxicillin–clavulanate in the treatment of acute bacterial sinusitis

• Published in: Current medical research and opinion 2008-06, Vol.24 (6), p.1691-1702
• Main Authors: Desrosiers, Martin, Ferguson, Berrylin, Michel Klossek, Jean, Drugeon, Henri, Mösges, Ralph
• Format: Article
• Language: English
• Subjects: Acute Disease; Adult; Amoxicillin - administration & dosage; Amoxicillin - pharmacology; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - pharmacology; Antibacterial agents; Bacterial Infections - drug therapy; Bacterial Infections - physiopathology; beta-Lactam Resistance - drug effects; Drug Administration Schedule; Female; Haemophilus influenzae; Haemophilus influenzae - drug effects; Humans; Ketolides; Ketolides - administration & dosage; Ketolides - pharmacology; Male; Middle Aged; Outcome Assessment (Health Care); Quality of Life; Sinusitis; Sinusitis - drug therapy; Sinusitis - physiopathology; Streptococcus pneumoniae; Streptococcus pneumoniae - drug effects; Surveys and Questionnaires; β-Lactam resistance
• ISSN: 0300-7995; 1473-4877
• DOI: 10.1185/03007990802133914

ABSTRACT Objective: This study compared the clinical efficacy, time to symptom resolution, and tolerability of a 5-day regimen of telithromycin with a 10-day regimen of high-dose amoxicillin–clavulanate in acute bacterial sinusitis (ABS). Research design and methods: In this multinational (41 centers in Canada, Germany, Greece, Portugal, and Turkey), open-label, noninferiority study, patients ≥18 years old (n = 298) with a clinical ( > 7 days' symptoms) and radiological (air/fluid level, total opacification, mucosal thickening ≥10 mm) diagnosis of ABS were randomized to receive telithromycin 800 mg once daily for 5 days or amoxicillin–clavulanate 875/125 mg twice daily for 10 days. Clinical efficacy and tolerability were assessed at the test-of-cure visit (days 17–21). Time to symptom resolution was based on patients' daily diary assessment of individual symptoms. Results: The per-protocol clinical success rate (primary endpoint) with telithromycin (88.6 % (109/123)) was noninferior to that with amoxicillin–clavulanate (88.8 % (111/125)) (95 % confidence interval: –8.9 to 8.5). In the modified intention-to-treat (mITT) population, the median time for 50 % reduction of total symptom scores was significantly shorter for telithromycin (4 days) vs. amoxicillin–clavulanate (5 days; p = 0.044); median times for 75 % reduction of total symptom scores were: telithromycin, 7 days; amoxicillin–clavulanate, 8 days (p = 0.115). The median time for reduction of total symptom scores to the absent/very mild category (mITT population) was 6 days for telithromycin vs. 8 days for amoxicillin–clavulanate (p = 0.04). All treatment-emergent adverse events (TEAEs) were mostly gastrointestinal and occurred in 20.7 % (30/145) of telithromycin-treated patients vs. 31.8 % (47/148) of amoxicillin–clavulanate-treated patients (p = 0.034). One serious AE was reported in the telithromycin group, but it was considered not to be related to treatment. Conclusions: This open-label, randomized study demonstrated that treatment of ABS with telithromycin resulted in comparable clinical efficacy, shorter times to symptom resolution, and fewer total TEAEs than treatment with amoxicillin–clavulanate.