Efficacy and Safety of Levofloxacin and Cefuroxime axetil in Acute Exacerbation of Chronic Bronchitis: A Comparative Study

Background: Acute exacerbation of chronic bronchitis (AECB) is a commonly encountered clinical problem and those suspected to be due to bacterial infections require antibiotic therapy. Objective: The study was designed to evaluate the effectiveness and safety of two commonly used antibiotics levofloxacin, a second generation fluoroquinolone, versus cefuroxime axetil, an oral second-generation cephalosporin, for the treatment of mild to moderately severe cases of AECB. Materials and Methods: This is a prospective, open labeled randomized study involving a total of 60 adult subjects diagnosed with chronic bronchitis with clinical symptoms suggestive of an Anthonisen type II acute exacerbation (any two of the following criteria - increased dyspnea, cough, sputum purulence). Forty eight patients who fulfilled the selection criteria were randomized to receive either levofloxacin 500 mg once daily or cefuroxime axetil 250 mg twice daily orally for 7 days. The primary outcome measure was clinical success rate at day 14 visit and the secondary out-come measures were changes in Clinical Global impression (CGI) scales and incidence of adverse events (AEs). Results: The clinical success rates were comparable (82.6% in levofloxacin group versus 77.3% in cefuroxime group) and no statistically significant difference was observed between the groups. AEs were mild, self-limiting and few (two in levofloxacin and three in cefuroxime arm) and tolerability was also good. Conclusion: A 7-day course of levofloxacin was convenient with once daily dose, was found to be economical and therapeutically comparable to cefuroxime in terms of both clinical effectiveness and safety for the treatment of AECB patients