Efficacy, Safety and Tolerability of Fesoterodine in Asian Patients with Overactive Bladder
- Authors
- Yamaguchi, Osamu; Nishizawa, Osamu; Takeda, Masayuki; Yoshida, Masaki; Choo, Myung-Soo; Lee, Jeong Gu; Lin, Alex Tong-Long; Lin, Ho-Hsiung; Yip, Wai-Chun Andrew; Isowa, Hitoshi; Hiro, Shintaro
- Issue Date
- Apr-2011
- Publisher
- Wiley Blackwell
- Keywords
- fesoterodine; overactive bladder; randomized controlled trial
- Citation
- LUTS: Lower Urinary Tract Symptoms, v.3, no.1, pp 43 - 50
- Pages
- 8
- Indexed
- SCIE
SCOPUS
- Journal Title
- LUTS: Lower Urinary Tract Symptoms
- Volume
- 3
- Number
- 1
- Start Page
- 43
- End Page
- 50
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/13589
- DOI
- 10.1111/j.1757-5672.2011.00091.x
- ISSN
- 1757-5664
1757-5672
- Abstract
- Objectives: 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.
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- Appears in
Collections - 2. Clinical Science > Department of Urology > 1. Journal Articles
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