Efficacy of fesoterodine over 24 hours in subjects with overactive bladder

Abstract

Objective:

Fesoterodine is an antimuscarinic agent indicated for the treatment of overactive bladder (OAB) symptoms. The objective of this study was to evaluate the efficacy of fesoterodine versus placebo over selected intervals during a 24-hour period in subjects with OAB.

Research design and methods:

In a post hoc analysis, data were analyzed from two randomized, double-blind, placebo-controlled 12-week phase III trials in which subjects with a history of OAB symptoms for ≥6 months were treated with morning doses of fesoterodine 4 mg, fesoterodine 8 mg, or placebo.

Clinical trial registration:

Trial registration: ClinicalTrials.gov identifier: NCT00220363.

Trial registration: ClinicalTrials.gov identifier: NCT00138723.

Main outcome measures:

Changes were evaluated in number of micturitions, urgency episodes, urgency urinary incontinence (UUI) episodes, and mean voided volume (MVV) divided into three 8-hour intervals: 08:00–15:59 (daytime), 16:00–23:59 (evening), and 00:00–07:59 (nighttime). Comparisons with placebo were made using analysis of covariance (for least squares mean changes) and Wilcoxon rank sum test (for median percent changes); differences were considered significant at p < 0.05.

Results:

Data from 1674 subjects, 80% of whom were women, were included in the analysis. At the end of treatment, the least squares mean change from baseline for all efficacy endpoints was significantly greater with fesoterodine 4 mg and fesoterodine 8 mg compared with placebo during each 8-hour time interval (all p < 0.05). Median percent change in number of micturitions, urgency episodes, and UUI episodes also was significantly greater with both fesoterodine doses compared with placebo during all time intervals (all p < 0.05).

Conclusions:

Fesoterodine 4 mg and 8 mg given once daily demonstrated efficacy over placebo for OAB symptoms during all three 8-hour intervals of a 24-hour period, thus providing clinical support for once-daily dosing. Limitations include that this was a post hoc analysis.

Key words::

• Antimuscarinic
• Efficacy
• Fesoterodine
• Once daily

Transparency

Declaration of funding

This study was sponsored by Pfizer Inc., New York, NY, USA.

Declaration of financial/ other relationships

D.S. has disclosed that he is a consultant to Allergan, Antares, Astellas, Pfizer and Watson; has received grants or research support from Pfizer; and has received honoraria from Allergan, Antares, Astellas, Pfizer and Watson. M.C.M. has disclosed that he has received research grants, consultancy and speaker honoraria from Astellas, Bayer, Boehringer, Elbion, Eli Lilly, Pfizer and Theravance. V.N. has disclosed that he is a consultant and speaker for Pfizer. J.D.M., J.W., and Z.G. have disclosed that they are employees of Pfizer.

Some peer reviewers receive honoraria from CMRO for their review work. The peer reviewers of this paper have disclosed that they have no relevant financial relationships.

Acknowledgment

Editorial support was provided by Colin Mitchell and Karen Zimmermann from Complete Healthcare Communications, Inc. and was funded by Pfizer.

Employees of Pfizer participated in the design and conduct of the study, collection and analysis of data, interpretation of the data and review and approval of the manuscript.