Efficacy, Safety and Tolerability of Fesoterodine for Overactive Bladder Syndrome

Abstract

The 2 doses of fesoterodine were well tolerated and they statistically significantly improved overactive bladder symptoms.

Flexible‐Dose Fesoterodine in Elderly Adults with Overactive Bladder: Results of the Randomized, Double‐Blind, Placebo‐Controlled Study of Fesoterodine in an Aging Population Trial

“…The majority of adverse events were mild or moderate (fesoterodine, 94%; placebo, 98%). No meaningful mean change from baseline (fesoterodine, n = 374; placebo, n = 382) to week 12 (fesoterodine, n = 341; placebo, n = 356) in MMSE score was observed in the fesoterodine (0.24 AE 1.76) or placebo [19][20][21][22][23][24][25][26][27][28][29][30] in the placebo group. No clinically relevant changes from baseline were observed in vital sign measurements in either group.…”

Summary of Anticholinergic Pharmacotherapy Available for Overactive Bladder

“…Both formulations of fesoterodine significantly improved urgency and UUI episodes, mean voided volume [37]. Nitti et al [38] recorded similar results in a subsequent phase 3 trial with 832 participants randomly assigned to placebo, fesoterodine (4 mg), or fesoterodine (8 mg). A pooled subanalysis from the two latter trials evaluated outcomes in 358 men [15].…”

“…Phase 3 trials show an incidence of 16% to 22% of dry mouth for the 4-mg dose and 34% to 36% for the 8-mg dose [37,38]. Older patients appear to be more susceptible to AEs, especially with the 8-mg dose.…”

“…Overall, fesoterodine has a similar AE profile to tolterodine, darifenacin, solifenacin, trospium, propiverine, and transdermal oxybutynin [28•]. Despite these unwanted AEs, the discontinuation rate due to AEs was low in the placebo-controlled trials of both Chapple [38].…”

Summary of Anticholinergic Pharmacotherapy Available for Overactive Bladder Dysfunction

“…Patients receiving 8 mg/day of fesoterodine reported a greater side effect profile compared with placebo and fesoterodine, 4 mg/day [16,66,67]. The most common AEs were dry mouth in 37.7% and 12.5% and constipation in 8.8% and 2.5% with 8 mg and 4 mg, respectively.…”