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Fesoterodine in patients with overactive bladder syndrome: can the severity of baseline urgency urinary incontinence predict dosing requirement?
Author(s) -
Cardozo Linda,
Khullar Vik,
Wang Joseph T.,
Guan Zhonghong,
Sand Peter K.
Publication year - 2010
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/j.1464-410x.2010.09202.x
Subject(s) - overactive bladder , placebo , medicine , post hoc analysis , urology , adverse effect , urinary incontinence , clinical trial , constipation , alternative medicine , pathology
Study Type – Therapy (RCT)
Level of Evidence 1b OBJECTIVES To determine whether baseline urgency urinary incontinence (UUI) episodes predict the need for increased doses of fesoterodine in patients with overactive bladder (OAB), as clinicians would benefit from data that help to predict which patients require higher doses of antimuscarinics to manage UUI episodes. PATIENTS AND METHODS In this pooled analysis of data from two double‐blind, placebo‐controlled trials, patients were randomized to placebo or fesoterodine 4 or 8 mg for 12 weeks and stratified into tertiles (>0–<2, 2–<4, or ≥4) according to the number of UUI episodes/24 h as recorded in 3‐day bladder diaries at baseline. The change in mean UUI episodes/24 h from baseline to end of study was assessed using analysis of covariance. RESULTS In a post hoc analysis of data from two clinical trials, there were significant reductions from baseline in UUI episodes for fesoterodine 4 and 8 mg vs placebo in patients ( n ) with >0–<2 (422), 2–<4 (424) and ≥4 (481) UUI episodes at baseline (all P < 0.01). In patients with 2–<4 and ≥4 UUI episodes at baseline, fesoterodine 8 mg gave significantly greater mean reductions (−1.92 and −4.17, respectively) vs fesoterodine 4 mg (−1.43 and −3.31) ( P < 0.05). The most common adverse events were dry mouth (placebo, 8%; fesoterodine 4 mg, 19%; and 8 mg, 35%) and constipation (placebo, 2%; fesoterodine 4 mg, 5%; and 8 mg, 6%). CONCLUSION Fesoterodine 4 and 8 mg significantly reduced UUI episodes vs placebo; this effect appeared to be greater with fesoterodine 8 mg in patients with ≥2 UUI episodes/24 h at baseline. Fesoterodine was well tolerated, although higher doses increased the incidence of adverse events. These findings might aid the clinical identification of patients with OAB who would most benefit from increasing the dose of fesoterodine from 4 to 8 mg.