Efficacy and tolerability of ceftibuten versus amoxicillin/clavulanate in the treatment of acute sinusitis.

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Abstract
The efficacy and tolerability of ceftibuten 400 mg o.d. or 200 mg b.i.d. was compared with amoxicillin/clavulanate (AMX/CA, 500 mg/125 mg) t.i.d. in the treatment of acute sinusitis. This was a multicenter, open, randomized, parallel-group 8-day study. In total, 450 patients were evaluable for safety and 400 patients for efficacy. At day 10, clinical cure rates were 83% in the ceftibuten 400 mg o.d. group, 87% in the ceftibuten 200 mg b.i.d. group and 89% in the AMX/CA t.i.d. group; the clinical/radiological cure rates were 52, 44 and 56%, respectively. Clinical and clinical/radiological cure rates at day 40 for the ceftibuten 400 mg o.d. group, ceftibuten 200 mg b.i.d. group and the AMX/CA t.i.d. group were similar, with clinical cure rates of 81, 82 and 87%, and clinical/radiological cure rates of 62, 58 and 63%, respectively. Most adverse events were mild. Ceftibuten, 400 mg o.d. or 200 mg b.i.d., was equally effective and well tolerated as AMX/CA t.i.d. in the treatment of acute sinusitis.

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