Comparative efficacy and safety of cefprozil versus penicillin, cefaclor and erythromycin in the treatment of streptococcal pharyngitis and tonsillitis

Abstract

Cefprozil is a new oral cephalosporin with an enhanced in vitro spectrum of activity that includes group A β-hemolytic streptococci (GABHS). Four multicenter randomized clinical trials were conducted to compare the clinical efficacy and safety of cefprozil administered once or twice a day for the treatment of mild to moderate GABHS tonsillitis and pharyngitis. A total of 1597 patients were enrolled in the trials. Patient demographics and severity of infection were similar for all treatment groups. In Study 1, cefprozil administered at 20 mg/kg once daily was clinically, in 68 of 76 patients (89 %) and bacteriologically, in 66 of 74 patients (89 %) superior to penicillin — 51 of 69 (74 %) and 46 of 69 (67 %) — administered three times a day in patients of two to 12 years of age. In Study 2, the patients enrolled were 13 years of age and older, and cefprozil administered at 20 mg/kg once a day had similar clinical (93 % vs. 90 %) and bacteriological (95 % vs. 94 %) response rates as cefaclor administered three times a day. Study 3 demonstrated that cefprozil administered twice daily was similar to penicillin given three times a day, the clinical satisfactory response being 164 of 175 (94 %) for cefprozil and 146 of 165 (88 %) for penicillin. In Study 4, identical clinical and bacteriologic responses (95 %) were observed for cefprozil administered once a day and erythromycin ethylsuccinate administered four times a day in children over two years of age. There were no significant differences in the incidence or severity of drug-related adverse events, which, when reported, were mild and transient. These studies suggest that cefprozil can provide therapy for the treatment of mild to moderate tonsillopharyngitis in a once-daily or twice-daily dosage regimen, and is a reasonable alternative to penicillin, cefaclor, and erythromycin.