title: Lomefloxacin versus norfloxacin versus ciprofloxacin in the treatment of complicated urinary tract infections.
abstract: The safety and efficacy of lomefloxacin 400 mg once daily in the treatment of complicated urinary tract infections (UTIs) were assessed in one open, non-comparative study (n = 101) and three comparative, multicenter studies - two versus norfloxacin 400 mg b.i.d. (n = 326) and one versus ciprofloxacin 500 mg b.i.d. (n = 150). The antibiotics were administered orally for 7-14 days. Safety was assessed by physical examination, laboratory tests and questioning of patients. Patients had initial counts of - 10(5) colony-forming units/ml (CFU/ml) of pathogens which were susceptible to the study drugs. Clinical and bacteriologic outcome were assessed 5-9 days post-treatment. Success (cure or improvement of presenting signs and symptoms) was achieved in approximately 90% of the patients, irrespective of the drug therapy used. Eradication of baseline pathogens was achieved with lomefloxacin in 79.4% (50 63 ) of evaluable patients in the open study, in 91.3% (84 92 ) of patients in the norfloxacin comparative studies and in 97.2% (70 72 ) of evaluable patients in the ciprofloxacin comparative study. Eradication was achieved in 78.4% (76 97 ) of norfloxacin-treated evaluable patients and in 95.7% (67 70 ) of evaluable patiens treated with ciprofloxacin. The results obtained with lomefloxacin were statistically significantly better than those obtained with norfloxacin (p = 0.015), but equivalent to those with ciprofloxacin (p = 0.626). Superinfections occurred in 5.3% (12 227 ) of evaluable patients treated with lomefloxacin and in 9.3% (9 97 ) treated with norfloxacin. There were no superinfections in the 70 evaluable patients treated with ciprofloxacin. Adverse events (mainly gastrointestinal) which were probably drug-related occurred in 6.7% (23 341 ) of patients treated with lomefloxacin, in 3.1% (5 160 ) pateints treated with norfloxacin and in 6.7% (5 75 ) of patients treated with ciprofloxacin. A once-daily regimen of lomefloxacin 400 mg was found to be safe and produced superior or equivalent eradication rates of norfloxacin and ciprofloxacin, respectively.
authors.affiliation: Urologic Clinic, Elisabeth Hospital, Straubing, Germany.
authors.forename: K G
authors.initials: KG
authors.lastname: Naber