Comparative safety and efficacy of clarithromycin and three oral cephalosporins in the treatment of outpatients with bacterial bronchitis

A pooled analysis of three double-blind, randomized trials comparing clarithromycin (500 mg twice daily, n = 317) with either cefuroxime axetil (500 mg twice daily), cefaclor (500 mg three times daily), or cefixime (400 mg once daily) (total n = 341) in the treatment of bacterial bronchitis was performed. For evaluable patients, successful clinical outcome (cure or improvement) was noted for 181 (94%) of 192 patients treated with clarithromycin and 188 (91%) of 206 patients treated with a cephalosporin (P = 0.335). Clinically significant improvement in signs and symptoms was comparable between treatment groups. Bacteriologic cure occurred in 172 (90%) of 192 patients treated with clarithromycin and 177 (86%) of 206 patients treated with a cephalosporin (P = 0.29). Eighty-four (27%) patients in the clarithromycin group and 78 (23%) in the cephalosporin group reported adverse events, excluding taste perversion (P = 0.319). The majority of adverse effects were mild or moderate in severity. Most adverse events were digestive system complaints and occurred at comparable rates in both groups. The new macrolide clarithromycin appears to be as effective and well-tolerated as reference cephalosporins in the treatment of bacterial bronchitis, including the treatment of infections caused by Haemophilus influenzae.