Twice-daily dosing of loracarbef 200 mg versus 400 mg in the treatment of patients with acute maxillary sinusitis.

Loracarbef is an oral synthetic beta-lactam antibiotic in the new carbacephem class. We conducted a multicenter, randomized, double-blind, parallel-group study to compare the efficacy and safety of loracarbef 200 mg twice daily (BID) and 400 mg BID when given orally for 10 days to patients 12 years of age and older with acute maxillary sinusitis. Because sinus aspirates for culture are not routinely obtained in the management of acute maxillary sinusitis, antimicrobial therapy usually is selected empirically. This study was designed to provide data simulating the usual clinical practice of treatment without sinus aspiration. Two hundred nine patients who met the entry criteria, which included abnormal pretherapy sinus radiographs compatible with acute maxillary sinusitis and symptoms of fewer than 4 weeks' duration, qualified for the clinical analyses. Of the 106 clinically qualified patients assigned to the 200-mg BID group, favorable clinical responses (cure and improvement) were noted in 86 (81.1%) patients. Of the 103 clinically qualified patients assigned to the 400-mg BID group, 84 (81.6%) patients had favorable clinical responses. These results compare favorably with accepted clinical response rates of 70% to 80% for beta-lactams selected on an empiric basis. At the end of the treatment period, favorable radiologic responses (resolved and improved) and favorable clinical responses occurred in 55 (51.9%) of the 106 clinically qualified patients in the 200-mg BID group and in 57 (55.3%) of the 103 clinically qualified patients in the 400-mg BID group. Mean roentgenogram scores for the clinically qualified patients were 2.3 for both groups before therapy and 1.3 and 1.5 after therapy for the 200-mg BID and 400-mg BID groups, respectively. The mean change from pretherapy to posttherapy by patient was 1.0 for the 200-mg BID group and 0.8 for the 400-mg BID group. There were no statistically significant differences between treatment groups in the incidence of specific adverse events reported during therapy. These data suggest that loracarbef 200 mg BID is comparable in efficacy and safety to loracarbef 400 mg BID in the treatment of patients with acute maxillary sinusitis.