The antimuscarinic drug fesoterodine seems to be an effective and well-tolerated treatment for elderly individuals with an overactive bladder (OAB), including those older than 75 years, show findings from a clinical trial.
In the Study of Fesoterodine in an Aging population (SOFIA), patients aged 65 years and older with OAB symptoms were randomly allocated to receive once-daily fesoterodine (n=398) or placebo (n=396) for 12 weeks and were stratified by age (>75 versus =75 years).
To date, a large proportion of the data on the use of antimuscarinic drugs for OAB in elderly adults has come from post-hoc analyses of participants aged 65 and older, explain Adrian Wagg (University of Alberta, Edmonton, Canada) and colleagues. "Few placebo-controlled studies have prospectively evaluated or reported age-stratified data on the efficacy and safety of antimuscarinics in this population."
As reported in the Journal of the American Geriatrics Society, bladder diaries kept by the SOFIA participants showed that the mean number of urgency episodes per 24 hours decreased from 8.5 at baseline to 4.6 by week 12 in the fesoterodine group, compared with a decrease from 8.8 to 6.3 per 24 hours in the placebo group.
Similarly, the per 24-hour number of micturitions, nocturnal micturitions, and incontinence pads used fell by a significantly greater degree in patients who received fesoterodine than in those who received placebo.
When the patients were stratified by age, there was no significant difference in the improved outcomes observed with fesoterodine versus placebo between patients aged over 75 years and those aged 75 years or younger.
In addition, rates of adverse events were generally similar between the fesoterodine and placebo groups, both overall and when the age stratification was applied.
"The safety profile of fesoterodine in this older population was similar to that reported in previous studies, with no new safety concerns and a low rate of discontinuation," writes the team. "The efficacy and safety profiles of fesoterodine in the SOFIA Trial support the favorable benefit:risk ratio of antimuscarinic drugs in older adults with OAB reported in previous trials."
"In addition, the study provides valuable data for individuals older than 75, indicating that fesoterodine is effective and well tolerated in this elderly subgroup," the researchers add.
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