title: Efficacy and tolerability of ceftibuten versus amoxicillin/clavulanate in the treatment of acute sinusitis.
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.
authors.affiliation: Department of Oto-Rhino-Laryngology, Hôpital Beaujon, Clichy, France.
authors.forename: O
authors.initials: O
authors.lastname: Sterkers
mesh_terms: D000284:Administration, Oral; D000328:Adult; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077722:Ceftibuten; D002511:Cephalosporins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D009296:Nasal Cavity / Q000382:microbiology; D012852:Sinusitis / Q000188:drug therapy* / Q000382:microbiology; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D002511:Cephalosporins; D004791:Enzyme Inhibitors; D019980:Amoxicillin-Potassium Clavulanate Combination; D000077722:Ceftibuten