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| |  Fesoterodine More Effective Than Extended-Release Tolterodine for Overactive Bladder: Presented at ICS By Jill Stein SAN FRANCISCO -- October 2, 2009 -- Fesoterodine is more effective than tolterodine extended release (ER) for decreasing urge urinary incontinence episodes in patients with overactive bladder (OAB), investigators announced here on October 1 at the 39th Annual Meeting of the International Continence Society (ICS). Sender Herschorn, MD, University of Toronto, Toronto, Ontario, and colleagues compared the efficacy and safety of fesoterodine with tolterodine ER and placebo. Subjects were randomised in a 2:2:1 ratio to treatment with fesoterodine 4 mg for 1 week, then fesoterodine 8 mg for 11 weeks, tolterodine ER 4 mg, or placebo (with sham dose escalation for tolterodine ER and placebo at week 1). All patients had OAB symptoms for at least 3 months; baseline bladder journals reported at least 8 micturitions per 24 hours and at least 1 urge urinary incontinence episode per 24 hours. The primary endpoint was the change from baseline to week 12 in the mean number of urge urinary incontinence episodes per 24 hours. Efficacy analyses were conducted using data from patients who took at least 1 dose of their assigned medication and who had at least 1 baseline or postbaseline assessment, with last observations carried forward. Overall, 679 fesoterodine-treated patients, 684 tolterodine ER-treated patients, and 334 placebo-treated patients were included in the analysis. At week 12, both fesoterodine and tolterodine ER significantly decreased the mean number of urge urinary incontinence episodes per 24 hours versus placebo, as evidenced by a significant location shift between the treatments (P < .001). Fesoterodine produced a significantly greater improvement than tolterodine ER, however, on this primary endpoint (P = .0172). Results of a post hoc analysis in patients with urge urinary incontinence episodes at baseline showed that 64% of the fesoterodine cohort reported zero urge urinary incontinence episodes at week 12 compared with 57% of the tolterodine ER group and 45% of the placebo group (45%) (P < .001 for both). The difference between tolterodine ER and placebo was also significant (P = .0153). Fesoterodine and tolterodine ER were both superior to placebo at week 12 in 24-hour micturitions, urgency episodes, and mean voided volume per micturition. A larger improvement with fesoterodine than tolterodine ER was shown on multiple quality of life measures. The active treatments were well tolerated, although adverse events were more common with fesoterodine than tolterodine ER or placebo, Dr. Herschorn noted. Funding for this study was provided by Pfizer Inc. [Presentation title: Efficacy and Safety of Fesoterodine for Overactive Bladder in a Double-Blind, Head-to-Head Comparison Trial With Tolterodine ER and Placebo. Abstract 710]
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