PMID- 23460503
OWN - NLM
STAT- MEDLINE
DCOM- 20140811
LR  - 20131216
IS  - 1520-6777 (Electronic)
IS  - 0733-2467 (Linking)
VI  - 33
IP  - 1
DP  - 2014 Jan
TI  - Long-term safety, tolerability and efficacy of flexible-dose fesoterodine in 
      elderly patients with overactive bladder: open-label extension of the SOFIA 
      trial.
PG  - 106-14
LID - 10.1002/nau.22383 [doi]
AB  - 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.
CI  - (c) 2013 Wiley Periodicals, Inc.
FAU - Wagg, Adrian
AU  - Wagg A
AD  - University of Alberta, Edmonton, Alberta, Canada.
FAU - Khullar, Vik
AU  - Khullar V
FAU - Michel, Martin C
AU  - Michel MC
FAU - Oelke, Matthias
AU  - Oelke M
FAU - Darekar, Amanda
AU  - Darekar A
FAU - Bitoun, Caty Ebel
AU  - Bitoun CE
LA  - eng
SI  - ClinicalTrials.gov/NCT00798434
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130304
PL  - United States
TA  - Neurourol Urodyn
JT  - Neurourology and urodynamics
JID - 8303326
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Muscarinic Antagonists)
RN  - 621G617227 (fesoterodine)
SB  - IM
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Benzhydryl Compounds/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Europe
MH  - Female
MH  - Humans
MH  - Male
MH  - Muscarinic Antagonists/adverse effects/*therapeutic use
MH  - Prospective Studies
MH  - Quality of Life
MH  - Time Factors
MH  - Treatment Outcome
MH  - Urinary Bladder/*drug effects/physiopathology
MH  - Urinary Bladder, Overactive/diagnosis/*drug therapy/physiopathology
MH  - Urinary Incontinence/diagnosis/*drug therapy/physiopathology
MH  - Urination/drug effects
OTO - NOTNLM
OT  - antimuscarinic
OT  - lower urinary tract symptoms
OT  - micturition
OT  - muscarinic antagonists
OT  - urinary incontinence
EDAT- 2013/03/06 06:00
MHDA- 2014/08/12 06:00
CRDT- 2013/03/06 06:00
PHST- 2012/09/26 00:00 [received]
PHST- 2013/01/18 00:00 [accepted]
PHST- 2013/03/06 06:00 [entrez]
PHST- 2013/03/06 06:00 [pubmed]
PHST- 2014/08/12 06:00 [medline]
AID - 10.1002/nau.22383 [doi]
PST - ppublish
SO  - Neurourol Urodyn. 2014 Jan;33(1):106-14. doi: 10.1002/nau.22383. Epub 2013 Mar 4.