The study evaluating the efficacy and safety of Toviaz 8mg (fesoterodine fumarate) in patients with overactive bladder (OAB), who had been taking Detrol LA 4mg for two weeks, has met the primary endpoint.
New York Presbyterian/Weill Cornell Medical Center in New York, the Iris Cantor Men’s Health Center director, Weill Cornell Medical College urology professor, principal investigator of the study Dr. Steven Kaplan said the study adds to the body of evidence supporting Toviaz as an effective treatment for patients with overactive bladder, including patients who may not have responded to Detrol LA.
"Health care professionals often question how to treat patients who have had a suboptimal response to Detrol LA, which is commonly used but does not have a dose higher than 4 mg, and these data may help to guide treatment decisions," Dr. Kaplan added.
The 14-week randomised, double-blind multicentre study treatment started with 4mg/day of fesoterodine or matching placebo for one week, after one week of treatment, the dose increased to 8mg/day of fesoterodine.
The Toviaz 4mg for one week followed by Toviaz 8mg statistically significantly reduced the average number of urge urinary incontinence episodes (-2.37 episodes from baseline) per 24 hours (p<0.0001) in OAB patients who had a suboptimal response to Detrol LA 4mg.
The parallel group, placebo-controlled study demonstrated consistent safety and tolerability profiles of fesoterodine and tolterodine compared to previous studies and reported dry mouth and constipation as common treatment-emergent adverse events.