Journal of Antimicrobial Chemotherapy, Vol 40, 63-72, Copyright © 1997 by The British Society for Antimicrobial Chemotherapy
CE Langan, R Cranfield, S Breisch and R Pettit
This randomized, multicentre, double-blind, double-dummy study compared the
efficacy and safety of grepafloxacin and amoxycillin in acute bacterial
exacerbations of chronic bronchitis (ABECB). Patients were randomized to
receive grepafloxacin 400 mg or 600 mg od, or amoxycillin 500 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 follow-up visit for the
population evaluable for clinical efficacy were 82% (165/202 patients) in
the grepafloxacin 400 mg group, 85% (175/206) in the grepafloxacin 600 mg
group and 85% (172/203 patients) in the amoxycillin group. The 95%
confidence interval confirmed the equivalence of the two grepafloxacin
doses and amoxycillin, with no significant difference between the
grepafloxacin groups. The microbiological success rates at follow-up showed
equivalence between the grepafloxacin 400 mg and amoxycillin groups: 86%
(144/168 isolates) and 83% (162/195), respectively. The grepafloxacin 600
mg group achieved a statistically significantly higher eradication rate
(92%, 150/164; 95% CI 2.0%, 16.1%) than the amoxycillin group in the
follow- up assessment for microbiological and clinical efficacy (evaluable
population). There was no significant difference between the two
grepafloxacin treatment groups (95% CI -13.3%, 0.9%; P= 0.087). All three
treatment regimens successfully eradicated the pathogens most commonly
isolated during the study, including Haemophilus influenzae, Moraxella
catarrhalis and Streptococcus pneumoniae. Grepafloxacin had a good safety
profile, comparable to that of amoxycillin, although grepafloxacin 600 mg
was associated with a higher incidence of nausea, dyspepsia and taste
perversion than amoxycillin. 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.
ORIGINAL ARTICLES
Randomized, double-blind study of grepafloxacin versus amoxycillin in patients with acute bacterial exacerbations of chronic bronchitis
Baillieston Health Centre, Department of Postgraduate Medical Education, University of Glasgow, UK.
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