Lomefloxacin versus norfloxacin versus ciprofloxacin in the treatment of complicated urinary tract infections.
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.
Naber
K G
KG
Urologic Clinic, Elisabeth Hospital, Straubing, Germany.