Long-Term Safety, Tolerability and Efficacy of Flexible-Dose Fesoterodine in Elderly Patients With Overactive Bladder: Open-Label Extension of the SOFIA Trial

AimsTo assess the long-term safety, tolerability, and efficacy of flexible-dose fesoterodine in elderly patients with OAB. MethodsPatients aged 65 years who completed a 12-week, randomized, double-blind, placebo-controlled trial were eligible for the 12-week, open-label (OL) extension phase. Patients who received double-blind placebo started on fesoterodine 4mg and could increase to 8mg after 4 or 8 weeks of OL treatment, while fesoterodine-treated patients continued on their double-blind dose; only one dose escalation or de-escalation was permitted. Discontinuations and adverse events (AEs) were monitored, and patients completed 3-day bladder diaries and patient-reported outcomes at the beginning and end of the 12-week OL phase. ResultsSix hundred fifty-four patients entered the 12-week OL extension (mean age 72 years; 52% women). AEs were reported by 30.7% and 48.1% of patients who had received double-blind fesoterodine and placebo, respectively; 1.9% and 9.4%, discontinued due to AEs, respectively. Patients who received double-blind fesoterodine maintained their efficacy response. After 12 weeks of OL treatment, efficacy outcomes in patients who received double-blind placebo were similar to those who had received double-blind fesoterodine. On average, the efficacy response was maintained for the duration of the study. ConclusionsFesoterodine was well tolerated and improvements in OAB symptoms and quality of life measures were not diminished with longer-term treatment of patients aged 65 years. Neurourol. Urodynam. 33:106-114, 2014. (c) 2013 Wiley Periodicals, Inc.