Efficacy, safety and tolerability of fesoterodine in asian patients with overactive bladder
Journal
LUTS: Lower Urinary Tract Symptoms
Journal Volume
3
Journal Issue
1
Pages
43-50
Date Issued
2011
Author(s)
Yamaguchi O.
Nishizawa O.
Takeda M.
Yoshida M.
Choo M.-S.
Gu Lee J.
Tong-Long Lin A.
Andrew Yip W.-C.
Isowa H.
Hiro S.
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. ? 2011 Blackwell Publishing Asia Pty Ltd.
SDGs
Other Subjects
fesoterodine; placebo; abnormal laboratory result; adult; aged; article; Asian; constipation; controlled study; cystitis; diarrhea; diastolic blood pressure; dizziness; double blind procedure; drug dose comparison; drug efficacy; drug fatality; drug induced headache; drug safety; drug tolerability; drug withdrawal; dysuria; female; heart rate; Hong Kong; human; Japan; Korea; major clinical study; male; micturition; morning dosage; overactive bladder; phase 2 clinical trial; priority journal; randomized controlled trial; residual urine; rhinopharyngitis; side effect; systolic blood pressure; Taiwan; urge incontinence; urine retention; xerostomia
Type
journal article