To provide an overview of the efficacy of gemifloxacin once daily for the treatment of acute exacerbations of chronic bronchitis (AECB).
Three controlled studies (Studies 068, 070 and 069) and one open-label study (Study 061) were conducted to demonstrate the efficacy of gemifloxacin in the treatment of AECB.
In the two principal clinical studies (Studies 068 and 070), the clinical and bacteriologic efficacy of gemifloxacin when administered for 5 days was at least as good as that of clarithromycin 500mg twice daily for 7 days and amoxicillin clavulanate 500mg/125mg tid for 7 days. In one supportive clinical study (Study 069), the clinical and bacteriologic efficacy of gemifloxacin when administered for 5 days was at least as good as that of trovafloxacin 200mg od for 5 days At the test of cure visit, the eradication rates of key AECB pathogens for the combined gemifloxacin treatment group from the principal and supportive clinical studies (Per Protocol population) were: H. influenzae (45/49, 91.8%), including beta-lactamase producing strains, M. catarrhalis (29/30, 96.7%), S. pneumoniae (15/20, 75.0%), including penicillin-resistant and macrolide-resistant strains, H. parainfluenzae (16/18, 88.9%), and S. aureus (5/7, 71.4%).In the open-label study (Study 061), high clinical and bacteriologic success rates were demonstrated with gemifloxacin 320 mg od administered for 7 days.
These data support the use of gemifloxacin at a dose of 320mg for 5 days to treat AECB due to H. influenzae (including beta-lactamase producing strains), M. catarrhalis, S. pneumoniae (including penicillin-resistant and macrolide-resistant strains), H. parainfluenzae and S. aureus.
Gemifloxacin represents a useful addition to the therapeutic options available to treat AECB.
D. Campbell, None.