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Novel agent eases overactive bladder symptoms.

SAVANNAH, GA. -- Fesoterodine significantly improved symptoms of overactive bladder in women with an apparent dose-related response in a subanalysis of pooled data from two phase III trials involving more than 1,500 women.

Women randomized to either 4 mg or 8 mg of the investigational drug showed significantly greater improvement in the number of micturitions per day, and the number of urgency urinary incontinence episodes per day, and perceived treatment response, Dr. Peter K. Sand reported in a poster presented at the annual meeting of the Society of Gynecologic Surgeons.

The researchers pooled data from two phase III randomized controlled trials in male and female patients at least 18 years old with frequency and urgency urinary incontinence. Frequency was defined as at least eight micturitions in 24 hours; urgency urinary incontinence was defined as at least one episode in 24 hours. This sub-analysis examined efficacy and tolerability in 1,543 women.

The women were randomized to 12 weeks of treatment with 4 mg fesoterodine (434), 8 mg fesoterodine (452), or placebo (430). One trial also included a positive control arm with 4 mg tolterodine extended release (227). Patients completed 3-day bladder diaries before randomization and at 2, 8, and 12 weeks after initiating treatment.

Women on 8 mg fesoterodine showed significantly greater improvement than those on 4 mg fesoterodine in urgency urinary incontinence episodes per day, number of continent days per week, and perceived treatment response, Dr. Sand, a professor of obstetrics and gynecology at Northwestern University, Chicago, and his associates reported at the meeting, which was jointly sponsored by the American College of Surgeons.

The median change in number of micturitions per day from baseline to trial end (the primary end point) decreased significantly in the women on 4 mg fesoterodine (1.8), 8 mg fesoterodine (1.9), and 4 mg tolterodine (1.9), compared with those on placebo (1.0).

At 12 weeks, the mean decrease from baseline in the number of episodes of urgency urinary incontinence per day was 2.3 for women on 8 mg fesoterodine. Those on 4 mg fesoterodine, 4 mg tolterodine, and placebo had mean decreases from baseline of 1.9 episodes, 1.7 episodes, and 1.1 episodes per day, respectively. The difference was significantly greater for the treatment groups versus the placebo group.

Mean volume voided significantly in-creased from baseline in women on 4 mg fesoterodine (25.5 mL/void), 8 mg fesoterodine (32.1 mL/void), and 4 mg tolterodine (26.6 mL/void), compared with placebo (9.4 mL/void).

The researchers extrapolated the number of continent days per week from 3-day bladder diaries. The mean change from baseline was significantly increased for women taking 4 mg fesoterodine (2.5 days), 8 mg fesoterodine (3 days), and 4 mg tolterodine (2.3 days), compared with placebo (1.7 days). The change in continent days per week was significantly greater for women on 8 mg fesoterodine than for women on 4 mg tolterodine. A positive treatment response was reported by 49%, 70%, 77%, and 74% in women receiving placebo, 4 mg fesoterodine, 8 mg fesoterodine, and 4 mg tolterodine, respectively. The women were asked to rate how their condition had improved--greatly improved, improved, not changed, or worsened. A positive treatment response was defined as "greatly improved" or "improved."

The study was funded by Schwarz Bio-Sciences, a subsidiary of Schwarz Pharma AG, and Pfizer Inc. Dr. Sand is an adviser to and an investigator for Pfizer. Another of the study authors is employed by Prizer.

The most common treatment-emergent adverse events at the end of the study were dry mouth, constipation, urinary tract in fection, and headache.

BY KERRI WACHTER

Senior Writer
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Title Annotation:Women's Health; fesoterodine
Author:Wachter, Kerri
Publication:Internal Medicine News
Geographic Code:1USA
Date:Jul 15, 2008
Words:611
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