Long-term safety, tolerability, and efficacy of fesoterodine treatment in men and women with overactive bladder symptoms

Abstract

Objective:

To evaluate long-term safety, tolerability, and efficacy of fesoterodine for men and women with overactive bladder (OAB) symptoms.

Research design and methods:

This was a post hoc analysis of data pooled from two open-label extensions (NCT00220402, NCT00220376) of double-blind studies. All subjects began open-label treatment with fesoterodine 8 mg once daily, with voluntary dose reduction to 4 mg and re-escalation to 8 mg each permitted once annually. Maximum allowable duration of open-label treatment ranged from 24 to 36 months.

Main outcome measures:

Safety and discontinuations were assessed throughout treatment; subject-reported treatment tolerability and 3-day bladder diaries were evaluated at open-label baseline and months 1, 4, 8, 12, and 24.

Results:

A total of 185 men and 705 women enrolled; 83 men (45%) and 356 women (50%) continued open-label treatment for ≥24 months. Most men (84%) and women (75%) remained on fesoterodine 8 mg throughout open-label treatment. No new or unexpected safety signals were observed. Dry mouth was the most common treatment-emergent adverse event (men, 24%; women, 32%), rates of discontinuation due to dry mouth were low (men, 1%; women, 2%). Most men and women (≥91%) reported at least ‘good’ tolerance. For men and women, statistically significant improvements in urgency urinary incontinence episodes, micturitions, urgency episodes, and mean voided volume per micturition achieved between double-blind baseline and open-label baseline were sustained or further improved through month 24; significant improvements in most OAB symptoms were observed between double-blind baseline and month 24 when subjects were stratified by double-blind treatment (placebo, tolterodine extended release 4 mg, fesoterodine 4 mg, fesoterodine 8 mg). Limitations include the lack of a placebo control and that subjects completing double-blind treatment may have been more likely to tolerate or respond to long-term fesoterodine treatment.

Conclusions:

Long-term fesoterodine treatment was well tolerated and associated with sustained improvements in OAB symptoms in men and women.

Trial registration: ClinicalTrials.gov identifier: NCT00220402.

Trial registration: ClinicalTrials.gov identifier: NCT00220376.

Key words::

• Efficacy
• Fesoterodine
• Health-related quality of life
• Overactive bladder
• Safety
• Tolerability

Transparency

Declaration of funding

Funding for this study was provided by Schwarz BioSciences GmbH and Pfizer Inc. Schwarz BioSciences GmbH designed and conducted this study; Pfizer Inc was involved in data analysis and manuscript preparation.

Declaration of financial/other relationships

H.S. has been a consultant for AMS, Pfizer, and Watson and a speaker for Astellas and Watson. C.J.K. has received educational funding for research from Pfizer and Astellas and is an advisor for Pfizer and Astellas. P.K.S. has been an advisor and speaker for Allergan, Astellas, GlaxoSmithKline, Ortho, Pfizer, and Watson and has received research grants from Allergan, Contura, Bioform, Boston Scientific, Ortho, Pfizer, and Watson. S.B., T.B., and M.C. are employees of Pfizer Inc.

CMRO peer reviewers may receive honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgments

Editorial assistance was provided by Nancy Sheridan and Colin Mitchell, PhD, from Complete Healthcare Communications, Inc., and was funded by Pfizer Inc.

Some of the data included in this manuscript were presented during a podium presentation at the 2009 American Urogynecologic Society Annual Scientific Meeting.