Cefprozil is a new oral
cephalosporin with an enhanced in vitro spectrum of activity that includes group A beta-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.(ABSTRACT TRUNCATED AT 250 WORDS)