A Multi-center Study to Evaluate the Efficacy and Safety of Balofloxacin and Ofloxacin for Patients with Uncomplicated Urinary Tract Infection / 대한비뇨기과학회지

ABSTRACT

PURPOSE: Balofloxacin is a new fluoroquinolone antibiotic that has potent, broad-spectrum, antimicrobial activity and a good safety profile during preclinical study. The aim of this study was to evaluate the efficacy and safety of balofloxacin in comparison with those of ofloxacin for uncomplicated urinary tract infections. MATERIALS AND METHODS: Patients randomly received oral balofloxacin at 100mg twice a day or oral ofloxacin at 200mg twice a day for 5 days at a ratio of 21. Efficacy was assessed by the eradication rate of baseline pathogens and clinical outcome of the objective disease. Safety was assessed by adverse events, changes in laboratory tests and vital signs. RESULTS: The bacteriological efficacy rate was 83.9%(99/118) in the balofloxacin group and 88.4%(61/69) in the ofloxacin group. In the equivalence test using 15% as the standard, clinically acceptable difference value of efficacy, balofloxacin was equivalent to ofloxacin [95% CI -14.6% to 5.5%]. The bacteriological evaluation of the case whose baseline pathogen was susceptible to the study drug was 96.6%(84/87) for the balofloxacin group and 92.6%(50/54) for the ofloxacin group [95% CI -4.0% to 11.9%], thereby demonstrating equivalence; as did the relatively high clinical success rates of 99.2% and 95.7%, respectively. The adverse event rate and the drug-related adverse event rate for the balofloxacin group was significantly lower than that of the ofloxacin group(p=0.036, 0.031). Neither unusual laboratory findings nor abnormal vital signs were reported for either group and there were no significant differences between the treatment groups. CONCLUSIONS: Twice daily administration of 100mg balofloxacin is as effective as twice daily administration of 200mg ofloxacin for the treatment of uncomplicated urinary tract infections. With regard to safety, balofloxacin was confirmed to be safer than ofloxacin.