Gemifloxacin versus amoxicillin/clavulanate in the treatment of acute exacerbations of chronic bronchitis. The 070 Clinical Study group.
Six hundred patients were evaluated in this randomized, double-blind, double-dummy, multicenter, parallel-group study comparing the efficacy and safety of gemifloxacin (320 mg once-daily for 5 days) and amoxicillin/clavulanate (500/125 mg three-times daily for 7 days) for the treatment of acute exacerbations of chronic bronchitis (AECB). Of note, more than 90% of study participants had stage 2 disease at study entry. The two drugs were found to be equally effective, with clinical success rates of 93.6% for gemifloxacin and 93.2% on amoxicillin/clavulanate (95% CI -3.9 to 4.6). Bacteriological success rates favored gemifloxacin (90.9% compared with 79.5% for amoxicillin/clavulanate; 95% CI -3.3 to 26.0); however, this difference was not statistically significant. Gemifloxacin and amoxicillin/clavulanate were both well tolerated. In summary, gemifloxacin was found to be well tolerated and effective for the treatment of AECB, suggesting it is well suited for empirical treatment of this common respiratory condition in the current clinical environment.
File
T
T
Summa Health System, Akron, USA. tfile@neoucom.ed
Schlemmer
B
B
Garau
J
J
Lode
H
H
Lynch
S
S
Young
C
C
D000210:Acute-Phase Reaction; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000494:pharmacology / Q000627:therapeutic use; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001991:Bronchitis / Q000188:drug therapy*; D002908:Chronic Disease; D019818:Clavulanic Acid / Q000494:pharmacology / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D024841:Fluoroquinolones; D000077735:Gemifloxacin; D006193:Haemophilus influenzae / Q000187:drug effects; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D001936:Moraxella catarrhalis / Q000187:drug effects; D015337:Multicenter Studies as Topic; D009287:Naphthyridines / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D013296:Streptococcus pneumoniae / Q000187:drug effects; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D009287:Naphthyridines; D019818:Clavulanic Acid; D000658:Amoxicillin; D000077735:Gemifloxacin