Efficacy, safety and tolerability of fesoterodine in asian patients with overactive bladder

Osamu Yamaguchi, Osamu Nishizawa, Masayuki Takeda, Masaki Yoshida, Myung Soo Choo, Jeong Gu Lee, Alex Tong-Long Lin, Ho Hsiung Lin, Wai Chun Andrew Yip, Hitoshi Isowa, Shintaro Hiro

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Abstract

To assess the efficacy, safety, and tolerability of fesoterodine 4 and 8 mg once daily (QD) compared with placebo in Asian subjects with overactive bladder (OAB) after 12 weeks of treatment. Methods: This phase II, dose-finding study consisted of a 2-week placebo run-in period followed by a 12-week, randomized, double-blind, placebo-controlled, treatment period. Eligible subjects were aged ≥20 years with ≥8 micturitions per 24 h and ≥1 urgency urinary incontinence (UUI) episodes per 24 h reported in a 3-day diary. The subjects were randomized to receive placebo, fesoterodine 4 mg, or fesoterodine 8 mg QD for 12 weeks. Results: Of 1232 subjects who entered the placebo run-in period, 951 received double-blind treatment. The mean number of UUI episodes per 24 h at baseline was 2.2 among the three treatment groups. The two fesoterodine groups showed statistically significant decreases from baseline in the mean number of UUI episodes per 24 h at week 12 (primary endpoint) compared with placebo. Most all-causality adverse events (e.g. dry mouth and constipation) were mild or moderate. The percentage of subjects with severe adverse events was low and similar among the treatment groups (placebo, 1.3%; fesoterodine 4 mg, 1.9%; fesoterodine 8 mg, 1.0%). Conclusion: Fesoterodine 4 and 8 mg QD were significantly better than placebo in improving OAB symptoms. Overall, the two fesoterodine dosing regimens were well tolerated. These results suggest that fesoterodine 4 and 8 mg QD are effective and well-tolerated treatments for OAB in Asian subjects.

Original languageEnglish
Pages (from-to)43-50
Number of pages8
JournalLUTS: Lower Urinary Tract Symptoms
Volume3
Issue number1
DOIs
Publication statusPublished - 2011 Apr 1

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Keywords

  • Fesoterodine
  • Overactive bladder
  • Randomized controlled trial

ASJC Scopus subject areas

  • Neurology
  • Urology

Cite this

Yamaguchi, O., Nishizawa, O., Takeda, M., Yoshida, M., Choo, M. S., Lee, J. G., Tong-Long Lin, A., Lin, H. H., Andrew Yip, W. C., Isowa, H., & Hiro, S. (2011). Efficacy, safety and tolerability of fesoterodine in asian patients with overactive bladder. LUTS: Lower Urinary Tract Symptoms, 3(1), 43-50. https://doi.org/10.1111/j.1757-5672.2011.00091.x