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.
RCT Entities:
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.