Traitement des exacerbations aiguës de bronchite chronique : efficacité et tolérance du céfuroxime axetil comparées à celles du cefpodoxime proxétil

Abstract

A multicentre, randomised, open-label study was performed in 50 centres to demonstrate that the clinical efficacy of oral cefuroxime axetil 250 mg twice daily is equivalent to that of oral cefpodoxime proxetil 200 mg twice daily in a 10-day treatment of acute bacterial exacerbations of chronic bronchitis. Exacerbations were defined as sputum purulence and an increase in severity of at least two of the following symptoms: sputum volume, cough or dyspnea. Clinical efficacy, classified as success (cure or improvement) or failure, was assessed at the end of treatment (days 10–12) and at follow-up (days 30–40). A total of 268 patients (130 cefuroxime axetil, 138 cefpodoxime proxetil) were randomised between March and May 1999. All patients were assessed for safety analysis, Intent-To-Treat and Per-Protocol analysis. At the end of treatment, clinical success rates were equivalent with 95% (124/130) success in the cefuroxime axetil group and 92% (127/138) in the cefpodoxime proxetil group. At follow-up, equivalence was also demonstrated in the Intent-To-Treat analysis with clinical success rates of 94% and 91% for patients receiving cefuroxime axetil and cefpodoxime proxetil respectively. A secondary efficacy end point based on resolution of sputum purulence also provided equivalent success rates in both treatment groups (97% of patients treated with cefuroxime axetil and 96% of patients treated with cefpodoxime proxetil). A recurrence was observed for 2% of the cefuroxime axetil patients (2/130) and for 1% of cefpodoxime proxetil patients (1/138). Drug-related adverse events were reported in 2% of patients of cefuroxime axetil group (2/130) and 7% of patients of cefpodoxime proxetil (9/138). No unexpected side effect were observed. This study demonstrates that cefuroxime axetil 250 mg twice daily has an efficacy equivalent to cefpodoxime proxetil 200 mg twice daily in treatment of acute bacterial exacerbations of chronic bronchitis in adults. Both regimens were well tolerated.