A comparison of the efficacy of telithromycin versus cefuroxime axetil in the treatment of acute bacterial maxillary sinusitis.

Author(s): Buchanan PP, Stephens TA, Leroy B

Affiliation(s): River Road Medical Group, 890 River Road, Eugene, OR 97404, USA.

Publication date & source: 2003-11, Am J Rhinol., 17(6):369-77.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

BACKGROUND: Telithromycin, a new ketolide, exhibits potent activity against respiratory pathogens, including resistant strains. METHODS: Five days of telithromycin (800 mg once daily) was compared with 10 days of cefuroxime axetil (250 mg twice daily) in subjects (n = 593) with acute bacterial maxillary sinusitis (ABMS). Bacteriologic sampling was accomplished by sinus puncture or nasal endoscopy. The primary efficacy variable was clinical outcome at the posttherapy/test-of-cure evaluation in clinically evaluable patients. RESULTS: Clinical cure was achieved in 85.2% of telithromycin patients and 82.0% of cefuroxime axetil patients (difference in proportions, 3.2%; 95% confidence interval, -7.1-13.4%). Satisfactory bacteriologic response rates were comparable. Treatment-emergent adverse events for both drugs were mild or moderate. The most frequently reported treatment-emergent adverse events were nausea and diarrhea. CONCLUSION: Once-daily telithromycin for 5 days was equivalent in efficacy to twice-daily cefuroxime axetil for 10 days in patients with ABMS. Telithromycin is a suitable option for short-course therapy of ABMS.