Safety and effectiveness of lomefloxacin in patients with acute exacerbation of chronic bronchitis (AECB) chronically treated with oral theophyllines.

Lomefloxacin is a difluorinated quinolone with excellent activity against a wide range of pathogens including those responsible for acute exacerbations of chronic bronchitis (AECB). This open, cross-sectional, multicenter study has evaluated the efficacy and safety of a once-daily dosage of 400 mg lomefloxacin in patients with AECB chronically treated with theophylline. 137 patients (96 males, 41 females; mean age 66.1+/-11.2 yrs) were enrolled and 133 completed the study. 81% suffered from moderate AECB, 16% severe AECB. The clinical success rate was very high (95%), as well as the microbiological (93%). Side effects were scarce and were significant only in 3 patients, with 2 dropouts. All patients were using theophylline derivatives twice daily and continued without any variation in dosage during the lomefloxacin treatment. Theophylline plasma levels determined in 103 patients at baseline, during and at the end of the lomefloxacin treatment did not significantly change. We conclude that orally administered lomefloxacin at standard recommended dosage is well tolerated and effective in elderly patients with AECB. No dose adjustment is required even when it is co-administered with methylxanthines.