Lomefloxacin versus amoxicillin in the treatment of acute exacerbations of chronic bronchitis: results of multinational studies.

The results of two large, multicenter studies comparing the safety and efficacy of lomefloxacin (400 mg administered orally once daily) and amoxicillin (500 mg administered orally three times daily) in adult patients with acute exacerbations of chronic bronchitis caused predominantly by Gram-negative pathogens have been combined. The studies were both randomized and blinded. One study enrolled 127 patients in 12 centers in Belgium; the second enrolled 510 patients in 52 centers in ten countries. The protocols were essentially identical, whicl allowed data to be pooled. A total of 253 lomefloxacin-treated patients and 254 amoxicillin-treated patients were considered evaluable. Both groups were well matched in terms of age, gender, and severity of presenting signs and symptoms. The most common pathogens in both treatment groups were Haemophilus influenzae, Pseudomonas aeruginosa, Streptococcus pneumoniae, Moraxella (Branhamella) catarrhalis, and Klebsiella pneumoniae. Two to four days after the conclusion of treatment, bacterial eradication rates were 85.4% for lomefloxacin-treated patients and 75.2% for patients receiving amoxicillin (p = 0.004). The clinical success rate (total of evaluable patients either cured or improved) 2-4 days after the conclusion of treatment for the lomefloxacin group was 90.9%, and for amoxicillin was 82.3% (p = 0.005). The incidence of adverse events was similar in both treatment groups, and no interactions were noted in those patients in both groups who received concomitant theophylline. In these studies, lomefloxacin administered once daily was superior to amoxicillin given three times daily to patients with acute bacterial exacerbations of chronic bronchitis caused predominantly by Gram-negative pathogens.