Long-term safety, tolerability and efficacy of flexible-dose fesoterodine in elderly patients with overactive bladder: Open-label extension of the SOFIA trial
Wagg A, Khullar V, Michel MC, Oelke M, Darekar A, Bitoun CE. Neurourol Urodyn. 2013 Mar 4. doi: 10.1002/nau.22383. [Epub ahead of print]

Source

University of Alberta, Edmonton, Alberta, Canada. adrian.wagg@ualberta.ca.

Abstract

AIMS:

To assess the long-term safety, tolerability, and efficacy of flexible-dose fesoterodine in elderly patients with OAB.

METHODS:

Patients 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 4 mg and could increase to 8 mg 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.

RESULTS:

Six 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.

CONCLUSIONS:

Fesoterodine 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.