Assessing the efficacy of fesoterodine for men with OAB
Tuesday, 8 December 2009- A group of researchers assessed the efficacy, safety, and tolerability of fesoterodine 4 and 8 mg in men with overactive bladder (OAB) and found that fesoterodine is generally safe and effective for men with OAB.
Herschorn and colleagues conducted a subanalysis of pooled data from 358 men enrolled in 2 double-blind, placebo-controlled phase III trials. Subjects with frequency and urgency or urgency urinary incontinence (UUI) were randomized to fesoterodine 4 mg, fesoterodine 8 mg, or placebo for 12 weeks. Efficacy endpoints included bladder diary variables and subject-reported treatment response.
The results, published in the Journal of Urology, showed that by week 12, men treated with fesoterodine 4 or 8 mg had significantly greater median percentage improvements in micturition frequency, urgency episodes, and UUI episodes versus placebo and significantly greater percentages reported a treatment response versus placebo.
Significant increases in mean voided volume (MVV) per micturition versus placebo occurred with fesoterodine 8 mg only. At week 12, fesoterodine 8 mg was significantly more efficacious than fesoterodine 4 mg in improving UUI episodes and MVV per micturition. The most commonly reported adverse events with fesoterodine 4 and 8 mg were dry mouth (12.5% and 37.7% vs 5.6% with placebo) and constipation (2.5% and 8.8% vs 0.8% with placebo).
Symptoms suggestive of urinary retention were reported in 0.8%, 0.8%, and 5.3% of men in the placebo, fesoterodine 4 mg, and fesoterodine 8 mg groups, respectively; only 1 subject, in the fesoterodine 8 mg group, was catheterized.
The researchers concluded that fesoterodine 4 and 8 mg are generally safe, efficacious, and well tolerated for the treatment of overactive bladder symptoms in men. The 8 mg dose provides additional benefit and allows for treatment individualisation.
Source: Sender Herschorn, J. Stephen Jones, et al., "Efficacy and Tolerability of Fesoterodine in Men With Overactive Bladder: A Pooled Analysis of 2 Phase III Studies," doi:10.1016/ Journal of Urology.2009.09.007
