Comparison of moxifloxacin and cefuroxime axetil in the treatment of acutemaxillary sinusitis

The aim of this prospective, multicenter, randomized, double-masked clinica l trial was to compare the efficacy and safety of moxifloxacin with those o f cefuroxime axetil for the treatment of community-acquired acute sinusitis . Five hundred forty-two adult patients with symptoms and radiographic evid ence of acute maxillary sinusitis received a 10-day oral regimen of either moxifloxacin (400 mg once daily) or cefuroxime axetil (250 mg twice daily). Acute signs and symptoms at presentation had lasted >7 days but <4 weeks. Clinical response at the end of therapy (7 to 14 days after treatment) was the primary efficacy variable. Four hundred fifty-seven of the patients (22 3 moxifloxacin, 234 cefuroxime axetil) were included in the clinical effica cy analysis. Moxifloxacin was found to be similar in effectiveness to cefur oxime axetil at the end-of-therapy visit (90% vs 89%, respectively; 95% con fidence interval, -5.1% to 6.2%). Clinical relapse at the follow-up visit w as reported for only 8 patients (3 moxifloxacin, 5 cefuroxime axetil), No c linically significant differences were observed with respect to the number of patients experiencing a successful clinical response based on demo,graph ic or infection characteristics. Five of the 542 enrolled patients were los t to follow-up. Of the 537 patients in the intent-to-treat population, drug -related adverse events were reported in 37% of moxifloxacin-treated patien ts and in 26% of cefuroxime axetil-treated patients (P = 0.006). Adverse-ev ent profiles were comparable in the 2 treatment groups, with the exception of nausea, which was reported by 11% of moxifloxacintreated patients compar ed with 4% of cefuroxime axetil-treated patients (P = 0.003). In this study , moxifloxacin was as effective as cefuroxime axetil in the treatment of co mmunity-acquired acute sinusitis.