Efficacy and tolerability of cefprozil versus amoxicillin/clavulanate for the treatment of adults with severe sinusitis

Cefprozil is a beta-lactamase-stable oral cephalosporin with an antimicrobial spectrum that includes gram-positive and gramnegative pathogens commonly associated with acute bacterial sinusitis, one of the most common upper respiratory tract infections among adults. We conducted a multicenter, open-label study to compare the efficacy and safety of cefprozil and amoxicillin/clavulanate in the treatment of adults with severe acute bacterial sinusitis diagnosed by clinical and radiographic criteria. A total of 278 patients entered the study, 140 (59 males, 81 females) in the cefprozil group and 138 (69 males, 69 females) in the amoxicillin/clavulanate group. Patients were randomized to 10 days of treatment with either cefprozil 500 mg BID or amoxicillin/clavulanate 500 mg/125 mg TID. Clinical severity was assessed at study entry, and patients were stratified based on symptom grade. Efficacy was evaluated using a 10-point questionnaire administered during, at the end of, and 2 weeks after completing therapy. At the end of treatment, 84.5% (71/84) of patients with severe sinusitis treated with cefprozil had a satisfactory clinical response, which was not significantly different from the 89.9% (80/89) of patients in the amoxicillin/clavulanate group who had a satisfactory clinical response. Two weeks after completing treatment, 80.8% (63/78) of cefprozil-treated patients and 81.0% (64/79) of amoxicillin/clavulanate-treated patients with severe sinusitis had a satisfactory response. Relapse was more common among amoxicillin/clavulanate patients (6/70; 8.6%) than among cefprozil patients (2/65; 3.1%), but the difference was not statistically significant. Significantly more amoxicillin/clavulanate-treated patients experienced adverse events compared with cefprozil-treated patients (P < 0.001), including diarrhea (P < 0.001), nausea (P < 0.042), and rash (P < 0.035). Three times as many amoxicillin/clavulanate patients discontinued treatment because of adverse events. Cefprozil demonstrated comparable clinical efficacy to amoxicillin/clavulanate in the treatment of adults with severe sinusitis; however, cefprozil was associated with a significantly lower incidence of diarrhea, nausea, and rash.