Korean J Urol.
2004 Jan;45(1):56-63.
A Multi-center Study to Evaluate the Efficacy and Safety of Balofloxacin and Ofloxacin for Patients with Uncomplicated Urinary Tract Infection
- Affiliations
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- 1Department of Urology, College of Medicine, Seoul National University, Korea.
- 2Department of Urology, Inha University, Korea.
- 3Department of Urology, Asan Medical Center, Korea.
- 4Department of Urology, Joongang University, Korea.
- 5Department of Urology, Sung Kyun Kwan University, Korea.
- 6Department of Urology, Gachon Medical School, Korea.
- 7Department of Urology, Korean Cancer Center Hospital, Korea.
- 8Department of Urology, Boramae Hospital, Korea.
- 9Department of Urology, Kangnam Hospital, Korea.
- 10Department of Urology, Dankook University, Korea.
- 11Department of Urology, Choongbuk National University, Korea.
- 12Department of Preventive Medicine, School of Medicine, Seoul National University, Seoul, Korea.
- 13Department of Clinical Pathology, School of Medicine, Seoul National University, Seoul, Korea.
Abstract
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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 2:1. 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.
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