EFFECTIVENESS OF SHORT-COURSE THERAPY (5 DAYS) WITH CEFUROXIME AXETILIN TREATMENT OF SECONDARY BACTERIAL-INFECTIONS OF ACUTE BRONCHITIS

Five hundred thirty-seven patients were enrolled in two independent, i nvestigator-blinded, multicenter, randomized clinical trials comparing the clinical and bacteriologic efficacies and the safety of 5- or 10- day treatment with cefuroxime axetil with those of 10-day treatment wi th amoxicillin-clavulanate in the treatment of secondary bacterial inf ections of acute bronchitis, Patients received either 5 or 10 days of treatment (n = 177 in each group) with cefuroxime axetil at 250 mg twi ce daily or 10 days of treatment (n = 183) with amoxicillin-clavulanat e at 500 mg three times daily, Patients in the cefuroxime axetil (5 da ys) group received placebo on days 6 to 10, Bacteriologic assessments were based on sputum specimen cultures obtained preceding and, when po ssible, following treatment, Organisms mere isolated from the pretreat ment sputum specimens of 242 of 537 (45%) patients, with the primary p athogens being Haemophilus influenzae, Haemophilus parainfluenzae. Mor axella catarrhalis, Streptococcus pneumoniae, and Staphylococcus aureu s (28, 25, 13, 9, and 8% of isolates, respectively), Pathogens were er adicated or presumed to be eradicated in 87% (52 of 60), 91% (53 of 58 ), and 86% (60 of 70) of bacteriologically evaluable patients treated with cefuroxime axetil (5 days), cefuroxime axetil (10 days), and amox icillin-clavulanate, respectively. A satisfactory clinical outcome (cu re or improvement) was achieved in 82% (107 of 130), 86% (117 of 136), and 83% (130 of 157) of the clinically evaluable patients treated wit h cefuroxime axetil (5 days), cefuroxime axetil (10 days), and amoxici llin-clavulanate, respectively. Treatment with amoxicillin-clavulanate was associated with a significantly higher incidence of drug-related adverse events than was treatment with cefuroxime axetil for either 5 or 10 days (P = 0.001), primarily reflecting a higher incidence of dru g-related gastrointestinal adverse events (37 versus 19 and 15%, respe ctively; P < 0.001), particularly diarrhea and nausea. These results i ndicate that treatment with cefuroxime axetil at 250 mg twice daily fo r 5 days is as effective as treatment for 10 days with either the same dose of cefuroxime axetil or amoxicillin-clavulanate at 500 mg three times daily in patients with acute bronchitis, In addition, treatment with cefuroxime axetil for either 5 or 10 days is associated with sign ificantly fewer gastrointestinal adverse events, particularly diarrhea and nausea, than is 10-day treatment with amoxicillin-clavulanate.