Osamu Yamaguchi1, Osamu Nishizawa1, Masayuki Takeda1, Masaki Yoshida1, Myung-Soo Choo1, Jeong Gu Lee1, Alex Tong-Long Lin1, Ho-Hsiung Lin1, Wai-Chun Andrew Yip1, Hitoshi Isowa1, Shintaro Hiro1. 1. Department of Urology, Fukushima Medical University School of Medicine, Fukushima, JapanDepartment of Urology, Shinshu University School of Medicine, Nagano, JapanDepartment of Urology, Yamanashi University, Yamanashi, JapanDepartment of Medical Informatics, Japan Labor Health and Welfare Organization, Kumamoto Rosai Hospital, Kumamoto, JapanDepartment of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, KoreaDepartment of Urology, College of Medicine, Korea University, Seoul, KoreaDepartment of Surgery, Taipei Veterans General Hospital and National Yang Ming University, Taipei, TaiwanDepartment of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei, TaiwanDepartment of Surgery, Kwong Wah Hospital, Hong Kong, ChinaPfizer Japan Inc, Tokyo, Japan.
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 theplacebo 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.
RCT Entities:
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.
Authors: William D Winkelman; Alison J Huang; Michael Schembri; Rebecca G Rogers; Holly Richter; Deborah L Myers; Stephen R Kraus; Karen C Johnson; Rachel Hess; Tomas Gregory; Catherine S Bradley; Lily Arya; Janette S Brown; Leslee L Subak Journal: Female Pelvic Med Reconstr Surg Date: 2017 Mar/Apr Impact factor: 2.091
Authors: Andy Wolff; Revan Kumar Joshi; Jörgen Ekström; Doron Aframian; Anne Marie Lynge Pedersen; Gordon Proctor; Nagamani Narayana; Alessandro Villa; Ying Wai Sia; Ardita Aliko; Richard McGowan; Alexander Ross Kerr; Siri Beier Jensen; Arjan Vissink; Colin Dawes Journal: Drugs R D Date: 2017-03