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Characteristics of antimuscarinic responders versus suboptimal responders in a randomized clinical trial of patients with overactive bladder symptoms

Journal article
Authors Lars Grenabo
S. Herschorn
S. A. Kaplan
L. Cardozo
D. Scholfield
D. Arumi
M. Carlsson
D. Chapman
F. Ntanios
Published in Current Medical Research and Opinion
Volume 33
Issue 10
Pages 1731-1736
ISSN 0300-7995
Publication year 2017
Published at Institute of Clinical Sciences, Department of Urology
Pages 1731-1736
Language en
Keywords Overactive bladder, urgency urinary incontinence, treatment response, antimuscarinics, fesoterodine, tolterodine, tolterodine extended-release, placebo-controlled trial, quality-of-life, head-to-head, 8 mg, fesoterodine, efficacy, agents, predict, onset, General & Internal Medicine, Research & Experimental Medicine
Subject categories Urology and Nephrology


Objective: To assess the characteristics of tolterodine extended-release (ER) 4mg responders and suboptimal responders (<= 50% decrease in UUI episodes/24 h) among patients with overactive bladder (OAB), including urgency urinary incontinence (UUI), and identify predictors of a >50% UUI response with fesoterodine 8mg in tolterodine suboptimal responders. Methods: Adult patients with OAB symptoms for >= 6 months and >= 8 micturitions, and >= 2 and <15 UUI episodes/24 h at week -2 received open-label tolterodine ER 4mg during a 2 week run-in. Suboptimal responders after tolterodine treatment (week 0) were randomized to fesoterodine (4mg for 1 week, 8mg for weeks 2-12) or placebo once daily. Post-hoc analyses compared the percentage change from week -2 to week 0 in UUI episodes/24 h in tolterodine responders versus suboptimal responders and identified significant predictors of a UUI response at week 12 with fesoterodine 8mg among tolterodine suboptimal responders. Results: Of 897 patients, 610 (68%) were UUI suboptimal responders during the run-in period. UUI episodes/24 h at week -2 were similar in tolterodine responders and suboptimal responders (4.2 vs. 4.3), but responders showed a significantly greater median percentage decrease in UUI episodes/24 h after tolterodine treatment at week 0 (80.0% versus 15.3%; p<.0001). During double-blind treatment, the percentage of patients with a UUI response at week 12 was significantly greater with fesoterodine (69.9%) than placebo (57.0%; p = .0027). Fesoterodine (vs. placebo), no previous antimuscarinic use before tolterodine run-in, and less UUI severity at baseline were significant predictors of a UUI response. Conclusions: For patients with OAB, including UUI, who were treated initially with tolterodine and showed a suboptimal UUI response, nearly 70% demonstrated a UUI response with second-line fesoterodine 8mg. No antimuscarinic use before tolterodine and fewer baseline UUI episodes were significant predictors of a UUI response with fesoterodine.

Page Manager: Webmaster|Last update: 9/11/2012

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