COMPARATIVE CLINICAL EFFICACY OF CEFETAMET PIVOXIL IN LOWER RESPIRATORY-TRACT INFECTION

Cefetamet pivoxil, because of its activity against respiratory pathoge ns and its pharmacokinetic behaviour, is expected to have clinical eff icacy in the treatment of lower respiratory tract infection (LRTI). Th is paper presents an overview of clinical trials conducted worldwide t o investigate the efficacy and tolerability of cefetamet pivoxil in th e treatment of adults and children with LRTI. A total of 626 adult pat ients, the majority of whom presented with exacerbations of chronic br onchitis (n = 500), received oral cefetamet pivoxil 500 or 1000mg twic e daily for 5 to 10 days' (n = 351) or a standard comparator agent (n = 275). The comparator agents were amoxicillin (750mg 3 or 4 times dai ly, or 1000mg twice daily), amoxicillin/clavulanic acid (625mg 3 times daily), or cefaclor (250 or 500mg 3 times daily) administered for 5 t o 12 days. A satisfactory clinical outcome (cure + improvement) was ac hieved in 79 to 94% of evaluable patients. In 336 children, 240 receiv ed cefetamet pivoxil at 2 dosage levels(10 or 20 mg/kg twice daily) fo r 7 to 12 days and 96 received the standard comparator, cefaclor (10 m g/kg 3 times daily). Cefetamet pivoxil was clinically effective at bot h dosages, and did not differ significantly compared with cefaclor (cl inical cure rates of 97 to 99% with cefetamet pivoxil and 96% with cef aclor). A separate analysis of 305 patients with community-acquired pn eumonia showed clinical successes in 80 to 100% of adults, 75 to 78% o f elderly patients, and 98% of children treated with cefetamet pivoxil . The overall incidence of adverse events determined in 4867 patients was about 10% in adults and 14% in children. Gastrointestinal disturba nces were the most commonly reported adverse events.