A Comparison of Gemifloxacin and Clarithromycin in Acute Exacerbations of Chronic Bronchitis and Long-Term Clinical Outcomes

Clin Ther. 2002 Apr;24(4):639-52. doi: 10.1016/s0149-2918(02)85139-6.

Abstract

Background: Gemifloxacin is an enhanced-affinity quinolone with potent activity against lower respiratory tract pathogens.

Objective: The efficacy and safety of a 5-day course of gemifloxacin were compared with those of a standard 7-day regimen of clarithromycin in patients with an acute exacerbation of chronic bronchitis (AECB). The impact of treatment on the long-term (26 weeks) clinical outcome was also assessed.

Methods: The acute phase of this randomized, double-blind study was performed in 93 centers in 7 countries. Adult patients (age >40 years) with a history of chronic bronchitis and an Anthonisen type 1 acute exacerbation (increased dyspnea, cough, and sputum purulence) were eligible. Patients receiving systemic steroids at a dose of >10 mg prednisone or the equivalent were excluded. Patients were randomized to receive gemifloxacin 320 mg once daily for 5 days or clarithromycin 500 mg twice daily for 7 days. Clinical and bacteriologic response rates were assessed at the end-of-therapy visit (days 8-12), the week 2-3 follow-up visit (days 13-24), and the week 4-5 follow-up visit (days 25-38). The long-term phase (26 weeks), which included US and Canadian participants only, evaluated the proportion of patients who remained free of a recurrence of AECB requiring additional antimicrobial therapy after resolution of the initial episode.

Results: Seven hundred twelve patients were randomized to treatment, 351 to gemifloxacin and 361 to clarithromycin. The long-term study included 438 patients, 214 receiving gemifloxacin and 224 receiving clarithromycin. Clinical success rates at the 2-3 week follow-up visit were 85.4% for gemifloxacin and 84.6% for clarithromycin. Bacteriologic success rates were 86.7% for gemifloxacin and 73.1% for clarithromycin. Significantly more patients receiving gemifloxacin than clarithromycin remained free of AECB recurrences (71.0% vs 58.5%, respectively; P = 0.016). Both treatments were well tolerated.

Conclusions: In the acute treatment of Anthonisen type 1 AECB, a 5-day course of gemifloxacin was at least as effective as a 7-day regimen of clarithromycin. In this population, significantly more patients receiving gemifloxacin remained free of AECB recurrence after 26 weeks compared with those receiving clarithromycin.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Anti-Infective Agents / adverse effects
  • Anti-Infective Agents / therapeutic use*
  • Bronchitis / drug therapy*
  • Bronchitis / microbiology
  • Chronic Disease
  • Clarithromycin / adverse effects
  • Clarithromycin / therapeutic use*
  • Double-Blind Method
  • Female
  • Fluoroquinolones*
  • Gemifloxacin
  • Haemophilus influenzae / drug effects
  • Humans
  • Male
  • Middle Aged
  • Naphthyridines / adverse effects
  • Naphthyridines / therapeutic use*
  • Recurrence
  • Sputum / microbiology
  • Treatment Outcome

Substances

  • Anti-Bacterial Agents
  • Anti-Infective Agents
  • Fluoroquinolones
  • Naphthyridines
  • Clarithromycin
  • Gemifloxacin