Clinical studies of gatifloxacin, a new fluoroquinolone, in genitourinary tract infections

Abstract

We published clinical study results on gatifloxacin (GFLX) in genitourinary tract infections in earlier issues of this journal. Recollation of case reports with source data has shown the necessity of some corrections in published papers. We therefore collectively report results based on our reanalysis of all data.
1. Overview of reanalysis
The overall conclusion of clinical efficacy after reanalysis is consistent with the previous conclusion reported. Satistical analysis of data from the dose-finding study and the double-binded comparative study showed that results of reanalysis do not differ in either of the studies from results already reported.
2. Clinical pharmacokinetics and tissue penetration
GFLXwas reconfirmed to have good transfer into serum and urine. Tissue concentrations in the prostate and epididymis were higher than that in serum. GFLX penetrated into prostate fluid and showed almost the same concentration as that in serum.
3. Clinical efficay
1) Acute uncomplicated urinary tract infections Overall clinical efficacy by criteria of the Japanese UTI Committee (UTI criteria) was 99.1% in acute uncomplicated cystitis. The double-blinded study showed no significant difference in final cure based on UTI criteria between3-day treatment and7-day treatment with GFLX at 100mg, twice a day.
2) Complicated urinary tract infections Overall clinical efficacy by UTI criteria was 80.8% in complicated urinary tract infections in open label studies. In the dose-finding study, the efficacy of GFLX at 200mg, twice a day, was higher than that at other doses or regimens, although there was no statistically significant difference. Thus, the dosage of 200mg of GFLX, twice a day, was considered optimal for treatment of urinary tract infections. The clinical equivalency of GFLX to levofloxacin was confirmed at Δ=10% in evaluation of efficacy in the doubleblinded comparative study.
3) Urethritis
MIC₉₀ of GFLX against 36 strains of Neisseria gonorrhoeae isolated from urethritis patients was 0.063μg/mL. Overall clinical efficacy by UTI criteria was 100% in gonococcal urethritis. Overall clinical efficacy in chlamydial urethritis was 100% after 14 days of treatment.
4) Prostatitis
Overall clinical efficacy by UTI criteria was 100% in both acute and chronic bacterial prostatitis.
5) Epididymitis
Clinical efficacy evaluated by the doctor in charge was “good” or “excellent” in 7 of 8 patients with epididymitis.
In conclusion, results indicate that GFLX is one of the most highly effective drugs in the treatment of genitourinary tract infections.