Studies of acute exacerbations of
chronic bronchitis (EXCB) included in the approval documents of
levofloxacin (LVF) were reviewed in light of the good conditions of use defined by the French marketing approval and the AFSSAPS recommendations. The approval documents included two American studies comparing LVF 500 mg/d for 5-7 days with
cefaclor 750 mg/d for 7-10 days or
cefuroxime axetil (CXM) 500 mg/d for 7-10 days. A new descriptive analysis of efficacy was performed on a population meeting the recommendation criteria for
antibiotic treatment in patients with clinical signs of obstruction. This analysis was stratified by number of risk factors (RF) for the following aggravating conditions: age above 65 years, diabetes or
corticosteroid therapy. In the American studies, clinical efficacy, measured by rate of success in the total population, in the EXCB population requiring
antibiotic therapy with or without risk factors, and in the EXCB population with at least one and at least two of the above-cited risk factors was 93.4% (351/376), 93.0% (268/288), 90.4% (122/135) and 94.4% (34/36) respectively with LVF and 92.2% (354/384), 92.5% (273/295), 87.7% (128/146) and 79.3% (23/29) respectively with the compared drugs. In the European study, the clinical efficacy in the total population, in the EXCB population requiring
antibiotic therapy with or without risk factors, and in the EXCB population with at least one and at least two of the above-cited risk factors was 81.9% (195/238), 82.4% (182/221), 78.9% (112/142) and 75.0% (27/36) respectively with LVF and 72.5% (166/229), 74.0% (154/208), 73.1% (95/130) and 58.3% (21/36) respectively with the compared drugs. The efficacy of
levofloxacin is thus confirmed for EXCB with signs of obstruction. When stratifying for RF, the efficacy of LVG persists with increasing numbers of RF, a result not observed with the compared drugs.