MULTICENTER COMPARATIVE TRIAL OF CIPROFLOXACIN VERSUS CEFUROXIME AXETIL IN THE TREATMENT OF ACUTE RHINOSINUSITIS IN A PRIMARY-CARE SETTING

In a primary care setting, the efficacy and safety of ciprofloxacin (C IP) 500 mg BID were compared with those of cefuroxime axetil (CA) 250 mg BID, each given for 10 days, in a nationwide, open, prospective, ra ndomized trial of 1414 adults with acute sinusitis. Patients were enro lled if they had clinically documented acute sinusitis (ie, rhinosinus itis) (<4 weeks' duration), based on the 1997 American Academy of Otor hinolaryngology-Head and Neck Surgery criteria of either two major or one major and two minor symptoms. The primary efficacy variable was cl inical response (resolution or failure) at the posttherapy assessment on study days 14 through 26. The most common presenting major signs an d symptoms of acute rhinosinusitis were facial congestion, nasal drain age/purulence, facial pain/pressure, and nasal obstruction/blockage. T he minor symptom, headache, was more common and severe than was nasal obstruction/blockage. A total of 1219 patients were clinically evaluab le. Clinical resolution was observed in 559 of 613 (91.2%) CIP-treated patients and 546 of 606 (90.1%) CA-treated patients. The two regimens were statistically equivalent (95% confidence interval, -2.16% to 4.7 1%), There were 80 drug-related adverse events reported in the CIP-tre ated patients and 81 drug-related adverse events reported in the CA-tr eated patients. The main adverse events were nausea (n = 18) and diarr hea (n = 7) in patients treated with CIP and diarrhea (n = 14), nausea (n = 12), headache (n = 7), and vaginitis (n = 7) in those treated wi th CA. CIP 500 mg BID was found to be statistically equivalent to CA 2 50 mg BID in the treatment of acute rhinosinusitis.