Fesoterodine Significantly Improves Treatment Response Rate in Subjects With Overactive Bladder as Early as 2 Weeks: Subpopulation Analyses of a Phase III Trial


Introduction and Objectives: In a previous report of data from this trial, fesoterodine (FESO) was shown to be effective in improving overactive bladder (OAB) symptoms. This subanalysis evaluated the efficacy of FESO as measured by self-reported Treatment Response rates at 2 and 12 weeks in all subjects with OAB and in subpopulations stratified by sex, age, and incontinence status.

Methods: This was a post-hoc subanalysis of data from a double-blind placebo- (PBO) controlled trial. Eligible subjects with frequency and urgency or urgency urinary incontinence were randomized to PBO, FESO 4 mg, FESO 8 mg, or tolterodine extended release (TOL ER) 4 mg for 12 weeks. Subjects assessed treatment benefit at 2 and 12 weeks using the 4-point Treatment Benefit Scale (My condition has been greatly improved [1]; improved [2]; not changed [3]; worsened [4], during treatment); responses of (1) or (2) were considered indicative of a positive Treatment Response. Treatment Response rates were analyzed using asymptotic normal approximation methodology for binary data. Data were stratified by sex (women, n = 889; men, n = 214), age (< 65 y, n=743; ≥ 65 y, n=360), and continence status (continent, n = 247; incontinent, n = 856).

Results: At 2 weeks, Treatment Response rates were significantly higher among subjects in the overall population treated with FESO 4 and 8 mg and TOL ER compared with PBO. Additionally, Treatment Response rates were significantly higher in subjects treated with FESO 8 mg vs PBO at 2 weeks in all subpopulations; Treatment Response rates in subjects treated with FESO 4 mg and TOL ER were significantly greater than PBO in most subpopulations. These improvements were generally maintained throughout the study. In men, FESO 8 mg was significantly more effective in improving Treatment Response rates than FESO 4 mg (2 weeks) and TOL ER (2 and 12 weeks). Similarly, at 12 weeks, FESO 8 mg was significantly more effective than TOL ER in incontinent subjects in improving Treatment Response rates. Other subpopulations showed no difference between treatment groups.

Conclusions: For most subpopulations, the percentage of subjects reporting a positive Treatment Response was significantly higher in those receiving FESO 4 or 8 mg or TOL ER vs those receiving PBO. This was seen both at 2 weeks and at end of treatment. At the end of the study, the percentage of men and incontinent subjects with a positive Treatment Response was significantly higher for those receiving FESO 8 mg compared with TOL ER.

KEYWORDS: Fesoterodine, muscarinic antagonists, overactive bladder, patient outcome assessment, urinary incontinence

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