The Efficacy and Safety of a Once-daily Extended-release Ciprofloxacin Tablet for the Empirical Treatment of Symptomatic Uncomplicated Cystitis in Korean Women / 대한비뇨기과학회지

ABSTRACT

PURPOSE: To compare the efficacy and safety of a 3-day regimen of extended-release ciprofloxacin (ciprofloxacin ER), 500mg qd, with trimethoprim-sulfamethoxazole (TMP/SMX), 800mg/160mg bid, for the empirical treatment of acute uncomplicated cystitis in Korean women. MATERIALS AND METHODS: A randomized, single-blind treatment trial of 75 women with acute uncomplicated cystitis was conducted. The women were prescribed ciprofloxacin ER, 500mg qd, or TMP/SMX, 800mg/160 mg, bid for 3 days. The patients were assessed in terms of the clinical and microbiological outcome and safety 7 days after treatment. RESULTS: Sixty-five women were eligible for the analyses (32 ciprofloxacin ER and 33 TMP/SMX). The most prevalent causative organism was Escherichia coli (76.9%), followed by Proteus (6.2%) and coagulase-negative Staphylococcus (6.2%). The rates of in vitro susceptibility to ciprofloxacin and TMP/SMX were 86.2 (56/65) and 73.4% (48/65), respectively. The clinical cure rates with ciprofloxacin ER and TMP/SMX were 87.5 and 78.8%, respectively. Microbiological cures at 7 days were observed in 25 of the 32 (78.1%) with ciprofloxacin ER and 18 of the 33 (54.5%) with TMP/SMX. The mean interval to improvement in the clinical symptoms after ciprofloxacin and TMP/SMX medications were 1.93+/-0.55 and 2.92+/-0.48 days, respectively. Adverse events with ciprofloxacin and TMP/SMX occurred in 28.1 and 15.5%, respectively, but both treatments were well tolerated. CONCLUSIONS: Although some organisms were resistant (13.8%) to ciprofloxacin, ciprofloxacin ER was superior to TMP/SMX in terms of the clinical and microbiological cure rates and the mean interval to improvement in the clinical symptoms. The high prevalence of resistance and low microbiological cure rates for TMP/SMX suggest that this drug does not provide an adequate initial therapy, while once-daily ciprofloxacin ER was safe and effective in the empirical treatment of symptomatic uncomplicated cystitis.