Objective: To review the efficacy and safety of fesoterodine, a new antimuscarinic for treating overactive bladder (OAB) symptoms.
Methods: Review of efficacy and safety data from the pivotal phase 3 trials of fesoterodine for the treatment of OAB. Although there were a number of additional end points, they were not included in the US prescribing information for fesoterodine and thus are not included in this article.
Results: OAB is a chronic condition affecting both men and women. The principal symptom is urgency, with or without urgency incontinence, with some patients experiencing increased daytime frequency and nocturia. In two 12-week, randomized, double-blind, phase 3 trials, fesoterodine 4 and 8 mg administered once daily were significantly better than placebo in alleviating OAB symptoms, as determined by changes in bladder diary variables. Both doses of fesoterodine were well tolerated.
Conclusions: Fesoterodine is an efficacious, well-tolerated treatment for OAB.
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