To demonstrate that five days of treatment with gemifloxacin is at least as effective as seven days of treatment with levofloxacin in adult patients with acute exacerbation of chronic bronchitis (AECB).
A total of 360 adults (>40yrs of age) with AECB were randomly assigned gemifloxacin 320 mg once daily for 5 days or levofloxacin 500 mg once daily for 7 days in a randomized, double-blind, double dummy, multicenter, parallel group study.
In total, 335/360 patients completed the study (93.1%). Seven patients receiving gemifloxacin withdrew from the study compared to 18 patients receiving levofloxacin; this difference was statistically significant (Fisher’s Exact Test: p=0.02). In the ITT (intent-to-treat) population, the clinical success rate at follow-up (Day 14–21) was 85.2% (155/182) with gemifloxacin and 78.1% (139/178) with levofloxacin. Clinical success rate in the per-protocol (PP) population was 88.2% (134/152) with gemifloxacin and 85.1% (126/148) with levofloxacin. At long-term follow-up (Day 28–35), the clinical success rates in the PP population were 83.7% (123/147) with gemifloxacin and 78.4% (109/139) with levofloxacin. The difference in success rates was 5.26% (95% CI: –3.83, 14.34). In the ITT population, clinical success rate at long-term follow-up was 80.8% with gemifloxacin and 70.8% with levofloxacin. The 95% CI for the treatment difference (1.18, 18.78) shows statistical superiority of gemifloxacin over levofloxacin for clinical efficacy at long-term follow-up in the ITT population.
The clinical efficacy of gemifloxacin 320mg once daily for five days in AECB was at least as good as levofloxacin 500mg once daily for seven days. Fewer withdrawals and superior clinical efficacy at long term follow-up were also seen with gemifloxacin.
Gemifloxacin represents an excellent therapeutic option for the treatment of AECB.
G.S. Tillotson, Oscient Pharmaceuticals