Comparison of fesoterodine and tolterodine extended release for the treatment of overactive bladder: a head‐to‐head placebo‐controlled trial

Abstract

voided volume per void (MVV); and the OAB questionnaire (OAB-q), Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS). Safety and tolerability were assessed and summarized over the 12-week study period. RESULTSFesoterodine (636 patients) significantly improved UUI episodes at week 12 (primary endpoint) compared with tolterodine ER (641 patients; P = 0.017) and placebo (313 patients; P < 0.001). Fesoterodine also produced significantly greater improvements than tolterodine ER in MVV ( P = 0.005). Fesoterodine significantly improved all diary endpoints compared with placebo ( P < 0.001), except for nocturnal voids ( P = 0.327). Tolterodine ER significantly improved all diary endpoints vs placebo ( P < 0.001), except for nocturnal voids ( P = 0.506) and MVV ( P = 0.103). Diary dry rates (the proportion of patients reporting no UUI episodes at endpoint among those with one or more UUI episodes at baseline) were significantly higher with fesoterodine (64%) than with tolterodine ER (57%; P = 0.015) and placebo (45%; P < 0.001). Improvements in PPBC, UPS and OAB-q scale and domain scores at week 12 were all significantly better with fesoterodine than placebo (all P < 0.001) and tolterodine ER (all P < 0.05) except for the OAB-q Sleep domain vs tolterodine ER ( P = 0.081). Dry mouth and constipation rates were 28% and 5% in the fesoterodine group, 16% and 4% in the tolterodine ER group, and 6% and 3% with placebo, respectively. Discontinuations due to treatment-emergent adverse events were 6%, 4% and 2% in the fesoterodine, tolterodine ER, and placebo groups, respectively. CONCLUSIONIn patients with OAB, fesoterodine 8 mg showed superior efficacy over tolterodine ER 4 mg and placebo in reducing UUI episodes (primary endpoint) and in improving most patient-reported outcome measures. Both active treatments were well tolerated.

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 number of participants who required catheterization (n = 3, 0.8% vs n = 1, 0.3%) and the number who discontinued the study because of urinary retention (n = 4, 1.0% vs n = 1, 0.3%) were also higher with fesoterodine than placebo. The overall discontinuation rates in the fesoterodine (19.9%) and placebo (13.2%) groups in the present study were at the high end of the range of discontinuation rates observed in fesoterodine (10-21%) and placebo (9-15%) arms of trials conducted in younger participants; 18,19,34,35 discontinuation rates in the present study were slightly higher in participants older than 75 in both treatment groups.…”

Pharmacologic Management of Overactive Bladder and Urge Incontinence: A Review of New and Old Treatment Options

“…In patients with pharmacogenomics variations in CYP2D6, the balance between toxicity and efficacy could be altered with tolterodine. Fesoterodine would not be affected by CYP2D6 polymorphisms [20]. Unfortunately, side effects are no less common with fesoterodine versus tolterodine, with dry mouth being the most commonly reported reason for discontinuation [17].…”

Clinical Use of Tolterodine Extended Release in Overactive Bladder

“…Herschorn et al 65 compared Fesoterodine and Tolterodine ER in a 12-week double-blind, double-dummy, placebo-controlled, randomized clinical trial that included 1,712 patients. Fesoterodine showed superior efficacy over Tolterodine ER 4 mg in reducing UUI episodes (primary endpoint), total and nocturnal voids, urgency episodes, severe urgency episodes, and frequency-urgency sum per 24 h, mean voided volume per void, except for nocturnal voids, and in improving most patient-reported outcome measures, except for the OABq sleep domain.…”