title: Long-term safety, tolerability and efficacy of flexible-dose fesoterodine in elderly patients with overactive bladder: open-label extension of the SOFIA trial.
abstract: OBJECTIVE
  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.
authors: University of Alberta, Edmonton, Alberta, Canada.
authors: Adrian
authors: A
authors: Wagg
authors: Vik
authors: V
authors: Khullar
authors: Martin C
authors: MC
authors: Michel
authors: Matthias
authors: M
authors: Oelke
authors: Amanda
authors: A
authors: Darekar
authors: Caty Ebel
authors: CE
authors: Bitoun
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000187:drug effects* / Q000503:physiopathology; D053201:Urinary Bladder, Overactive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D014549:Urinary Incontinence / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D014554:Urination / Q000187:drug effects
chemical_list: D001559:Benzhydryl Compounds; D018727:Muscarinic Antagonists; C526675:fesoterodine
keywords: antimuscarinic; lower urinary tract symptoms; micturition; muscarinic antagonists; urinary incontinence