title: Long-term safety, tolerability, and efficacy of fesoterodine treatment in men and women with overactive bladder symptoms.
abstract: OBJECTIVE
  To evaluate long-term safety, tolerability, and efficacy of fesoterodine for men and women with overactive bladder (OAB) symptoms.
  
  
  METHODS
  This was a post hoc analysis of data pooled from two open-label extensions (NCT00220402, NCT00220376) of double-blind studies. All subjects began open-label treatment with fesoterodine 8 mg once daily, with voluntary dose reduction to 4 mg and re-escalation to 8 mg each permitted once annually. Maximum allowable duration of open-label treatment ranged from 24 to 36 months.
  
  
  METHODS
  Safety and discontinuations were assessed throughout treatment; subject-reported treatment tolerability and 3-day bladder diaries were evaluated at open-label baseline and months 1, 4, 8, 12, and 24.
  
  
  RESULTS
  A total of 185 men and 705 women enrolled; 83 men (45%) and 356 women (50%) continued open-label treatment for ≥ 24 months. Most men (84%) and women (75%) remained on fesoterodine 8 mg throughout open-label treatment. No new or unexpected safety signals were observed. Dry mouth was the most common treatment-emergent adverse event (men, 24%; women, 32%), rates of discontinuation due to dry mouth were low (men, 1%; women, 2%). Most men and women (≥ 91%) reported at least 'good' tolerance. For men and women, statistically significant improvements in urgency urinary incontinence episodes, micturitions, urgency episodes, and mean voided volume per micturition achieved between double-blind baseline and open-label baseline were sustained or further improved through month 24; significant improvements in most OAB symptoms were observed between double-blind baseline and month 24 when subjects were stratified by double-blind treatment (placebo, tolterodine extended release 4 mg, fesoterodine 4 mg, fesoterodine 8 mg). Limitations include the lack of a placebo control and that subjects completing double-blind treatment may have been more likely to tolerate or respond to long-term fesoterodine treatment.
  
  
  CONCLUSIONS
  Long-term fesoterodine treatment was well tolerated and associated with sustained improvements in OAB symptoms in men and women.
authors.affiliation: Associated Urologists, Nashville, TN 37205, USA. hscarpero@comcast.net
authors.forename: Harriette
authors.initials: H
authors.lastname: Scarpero
authors.forename: Peter K
authors.initials: PK
authors.lastname: Sand
authors.forename: Con J
authors.initials: CJ
authors.lastname: Kelleher
authors.forename: Sandra
authors.initials: S
authors.lastname: Berriman
authors.forename: Tamara
authors.initials: T
authors.lastname: Bavendam
authors.forename: Martin
authors.initials: M
authors.lastname: Carlsson
mesh_terms: D000328:Adult; D000368:Aged; D001559:Benzhydryl Compounds / Q000008:administration & dosage* / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D053201:Urinary Bladder, Overactive / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D001559:Benzhydryl Compounds; C526675:fesoterodine