Comparison of cefuroxime axetil and amoxicillin/clavulanate in the treatment of acute bacterial sinusitis

This double-masked, multicenter, randomized clinical trial compared the eff icacy and tolerability of cefuroxime axetil and amoxicillin/clavulanate in the treatment of acute bacterial maxillary sinusitis. A total of 263 patien ts with acute bacterial maxillary sinusitis were randomly assigned to recei ve 10 days of treatment with either cefuroxime axetil 250 mg twice daily (n = 132) or amoxicillin/clavulanate 500/125 mg 3 times daily (n = 131). Pati ents' responses to treatment were assessed once during treatment (6 to 8 da ys after the start of treatment), at the end of treatment (1 to 3 days post treatment), and at follow-up (26 to 30 days after cessation of treatment). Clinical success, defined as cure or improvement, was equivalent in the cef uroxime axetil and amoxicillin/clavulanate groups at the end-of-treatment a nd follow-up assessments. Patients in both groups showed improvements in sy mptoms of acute sinusitis at the during-treatment visit. Treatment with amo xicillin/clavulanate was associated with a significantly higher incidence o f drug-related adverse events than treatment with cefuroxime axetil (29% vs 17%), primarily reflecting a higher incidence of gastrointestinal adverse events (23% vs 11%), particularly diarrhea. Two patients in the cefuroxime axetil group and 8 patients in the amoxicillin/clavulanate group withdrew f rom the study due to adverse events (P = 0.06), These results indicate that cefuroxime axetil 250 mg twice daily is as effective as amoxicillin/clavul anate 500 mg 3 times daily in the treatment of acute sinusitis and produces fewer gastrointestinal adverse events.