Drug reduces urge incontinence in Overactive Bladder trial patients
Posted Aug 14 2012 10:44am
Fesoterodine fumarate (Toviaz) appears to reduce urge incontinence in patients with overactive bladder who had a suboptimal response to tolterodine tartrate extended release (Detrol LA), according to a phase IV study.
The 14-week randomized, placebo-controlled, double-blind multicenter study assessed fesoterodine, 8 mg, in patients with OAB who had been taking tolterodine, 4 mg, for 2 weeks and had less than 50% reduction in urge urinary incontinence episodes. After open-label treatment with tolterodine, 4 mg, treatment with fesoterodine, 4 mg, was started for 1 week, followed by treatment with fesoterodine, 8 mg.
The study results demonstrated that fesoterodine, 4 mg, for 1 week followed by fesoterodine, 8 mg, statistically significantly reduced the average number of urge urinary incontinence episodes (-2.37 episodes from baseline) per 24 hours (p<.0001) in OAB patients who had a suboptimal response to tolterodine, 4 mg. The safety and tolerability profiles of fesoterodine and tolterodine were consistent with previous studies. The most common treatment-emergent adverse events for both fesoterodine and tolterodine were dry mouth and constipation.
“This study adds to the body of evidence supporting fesoterodine as an effective treatment for patients with overactive bladder, including patients who may not have responded to tolterodine,” said principal investigator Steven A. Kaplan, MD, of New York-Presbyterian Hospital/Weill Cornell Medical Center, New York. “Health care professionals often question how to treat patients who have had a suboptimal response to tolterodine, which is commonly used but does not have a dose higher than 4 mg, and these data may help to guide treatment decisions.”