A CONTROLLED TRIAL OF LEVOFLOXACIN AND LOMEFLOXACIN IN THE TREATMENT OF COMPLICATED URINARY-TRACT INFECTION

Objectives. The efficacy and safety of levofloxacin and lomefloxacin i n complicated urinary tract infections (UTIs) were compared in a rando mized, open-label, multicenter study. Methods. Outpatients were random ized to receive levofloxacin (250 mg once daily) for 7 to 10 days or l omefloxacin (400 mg once daily) for 14 days. Three hundred thirty-six patients (171 with levofloxacin, 165 with lomefloxacin) were evaluable for microbiologic efficacy, and 461 patients (232 with levofloxacin, 229 with lomefloxacin) for safety. Results. The overall microbiologic eradication rate of pathogens was 95.5% (168 of 176) for levofloxacin and 91.7% (154 of 168) for lomefloxacin. Eradication rates with respec t to patients were 95.5% (163 of 171) and 92.1% (152 of 165) for levof loxacin and lomefloxacin, respectively. At the 5 to 9-day post-therapy visit, symptoms were completely resolved in 84.8% of levofloxacin-tre ated patients and were decreased in 8.2% (93.0% clinical success). Amo ng the lomefloxacin-treated patients, complete resolution was seen in 82.4%, with decreased symptoms in 6.1% (88.5% clinical success). Drug- related adverse events (AEs) were reported by 10 (2.6%) and 18 (5.2%) levofloxacin- and lomefloxacin-treated patients, respectively. Compare d with levofloxacin-treated patients, more lomefloxacin-treated patien ts experienced photosensitivity reactions (3 [1.3%] versus 0) and dizz iness (2 [0.9%] versus 0). Nausea (3 [1.3%] versus 1 [0.4%]) was more frequent in the levofloxacin-treated group. Six patients in each treat ment group had a gastrointestinal AE (1.7%); rash was reported more fr equently with lomefloxacin (4 patients [0.4%]) than with levofloxacin (1 patient [0.4%]). Discontinuation because of AEs was observed in 8 ( 3.4%) levofloxacin- and 14 (6.1%) lomefloxacin-treated patients. Concl usions. Once-daily levofloxacin is as effective as and has a superior tolerability profile than lomefloxacin in the treatment of complicated UTIs. (C) 1998, Elsevier Science Inc. All rights reserved.