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

Associated Urologists, Nashville, TN, USA.

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

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.

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.

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.

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

Written by:
Scarpero H, Sand PK, Kelleher CJ, Berriman S, Bavendam T, Carlsson M.   Are you the author?

Reference: Curr Med Res Opin. 2011 Mar 1. Epub ahead of print.
doi: 10.1185/03007995.2011.559581

PubMed Abstract
PMID: 21355814

UroToday.com Overactive Bladder (OAB) Section

email news signup