RANDOMIZED, DOUBLE-BLIND-STUDY OF GREPAFLOXACIN VERSUS AMOXICILLIN INPATIENTS WITH ACUTE BACTERIAL EXACERBATIONS OF CHRONIC-BRONCHITIS

This randomized, multicentre, double-blind, double-dummy study compare d the efficacy and safety of grepafloxacin and amoxycillin in acute ba cterial exacerbations of chronic bronchitis (ABECB). Patients were ran domized to receive grepafloxacin 400 mg or 600 mg od, or amoxycillin 5 00 mg tds, for 7 or 10 days. The trial recruited 656 patients, of whom 566 (86%) completed the study. Clinical success rates at the 2 week f ollow-up visit for the population evaluable for clinical efficacy were 82% (165/202 patients) in the grepafloxacin 400 mg group, 85% (175/20 6) in the grepafloxacin 600 mg group and 85% (172/203 patients) in the amoxycillin group. The 95% confidence interval confirmed the equivale nce of the two grepafloxacin doses and amoxycillin, with no significan t difference between the grepafloxacin groups. The microbiological suc cess rates at follow-up showed equivalence between the grepafloxacin 4 00 mg and amoxycillin groups: 86% (144/168 isolates) and 83% (162/195) , respectively. The grepafloxacin 600 mg group achieved a statisticall y significantly higher eradication rate (92%, 150/164; 95% CI 2.0%, 16 .1%) than the amoxycillin group in the follow-up assessment for microb iological and clinical efficacy (evaluable population). There was no s ignificant difference between the two grepafloxacin treatment groups ( 95% CI -13.3%, 0.9%; P= 0.087). All three treatment regimens successfu lly eradicated the pathogens most commonly isolated during the study, including Haemophilus influenzae, Moraxella catarrhalis and Streptococ cus pneumoniae. Grepafloxacin had a good safety profile, comparable to that of amoxycillin, although grepafloxacin 600 mg was associated wit h a higher incidence of nausea, dyspepsia and taste perversion than am oxycillin. It can be concluded that grepafloxacin 400 mg or 600 mg od is as effective as amoxycillin 500 mg tds in the treatment of ABECB.