In most subpopulations of patients with overactive bladder (OAB), the percentage of patients who respond positively to treatment is significantly higher in those who receive fesoterodine 4 or 8 mg or tolterodine extended release (ER) versus those treated with placebo, investigators announced here at the 23rd Annual Meeting of the European Association of Urology (EAU).
Importantly, the response was seen as early as two weeks and was usually maintained at the end of the 12-week treatment period.
Andrea Tubaro, MD, with Sant Andrea Hospital in Rome, Italy, and colleagues elsewhere assessed the efficacy of fesoterodine as measured by self-reported treatment response rates at two and 12 weeks in all subjects with OAB drawn from a recent phase III trial and in subpopulations stratified by sex, age, and incontinence status.
In the phase III trial involving men and women who had frequency and urgency or urgency urinary incontinence for at least six months along with at least moderate bladder problems on a six-point Likert scale, fesoterodine was shown to be effective in improving OAB symptoms.
For the sub-analysis, Dr. Tubaro’s team stratified data by sex (889 women and 214 men), age (743 patients under 65 years of age and 360 patients 65 years of age or older), and incontinence status (247 continent and 856 incontinent patients).
Treatment response was derived from a four-point Treatment Benefit Scale, where patients rated their condition as having greatly improved, improved, not changed, or worsened during treatment.
Results showed that for all supopulations, the proportion of patients who reported a positive treatment response was significantly higher in those receiving fesoterodine 8 mg versus those receiving placebo. This was observed at two weeks, which was the time of the earliest measurement, and persisted throughout the trial in most subgroups.
For most subgroups, the percentage of subjects reporting a positive treatment response was also significantly higher at two and 12 weeks in the fesoterodine 4 mg and tolterodine ER groups compared the with the placebo group.
At the end of the trial, the percentage of men and incontinent subjects with a positive treatment response was significantly higher among those receiving fesoterodine 8 mg versus tolterodine ER.
Dr. Tubaro said that the results from this analysis of different subpopulations are in line with previously published data demonstrating that fesoterodine 4 and 8 mg improves the treatment response rate in OAB patients.
Fesoterodine is a new antimuscarinic agent that acts functionally as a prodrug. It is rapidly and extensively hydrolyzed by nonspecific esterases to 5-hydroxymethyl toleterodine, which is also the active metabolite of tolterodine.
Overactive bladder is a chronic condition that affects up to 17 percent of adults in the U.S. and Europe.
By Jill Stein
Jillstein03@gmail.com