Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder.
OBJECTIVE
To determine the efficacy, tolerability, and safety of fesoterodine in subjects with overactive bladder (OAB).


METHODS
This was a multicentre, randomised, double-blind, placebo- and active-controlled trial with tolterodine extended release (ER) to assess the efficacy and safety of fesoterodine. Eligible subjects (> or =18 yr) with increased micturition frequency and urgency and/or urgency urinary incontinence (UUI) were randomised to placebo, fesoterodine 4 mg, fesoterodine 8 mg, or tolterodine ER 4 mg for 12 wk. The primary efficacy variable was a change from baseline to week 12 in micturitions per 24 h. Co-primary end points included change from baseline to week 12 in UUI episodes per 24 h and Treatment Response ("yes" or "no," based on four-point treatment benefit scale). Secondary efficacy variables included mean volume voided per micturition, continent days per week, and number of urgency episodes.


RESULTS
At the end of treatment, subjects taking fesoterodine 4 and 8 mg had significant (p<0.05) and clinically relevant improvements versus placebo in the primary, co-primary, and most secondary efficacy variables. Tolterodine ER (active control) also provided significantly greater improvement than placebo for most efficacy variables, confirming the sensitivity of the study design. A more pronounced effect was observed with fesoterodine 8 mg at most end points.


CONCLUSIONS
Both doses of fesoterodine were significantly better than placebo in improving the symptoms of OAB and produced a significantly greater Treatment Response versus placebo. Efficacy was more pronounced with fesoterodine 8 mg compared with the other treatments. Active treatments were well tolerated.
Chapple
Christopher
C
The Royal Hallamshire Hospital, Sheffield, UK. c.r.chapple@shef.ac.uk
Van Kerrebroeck
Philip
P
Tubaro
Andrea
A
Haag-Molkenteller
Cornelia
C
Forst
Hans-Theo
HT
Massow
Ute
U
Wang
Joseph
J
Brodsky
Marina
M
D000328:Adult; D000368:Aged; D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D003408:Cresols / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000627:therapeutic use; D018579:Patient Selection; D010665:Phenylpropanolamine / Q000627:therapeutic use; D012449:Safety; D000068737:Tolterodine Tartrate; D053201:Urinary Bladder, Overactive / Q000145:classification / Q000188:drug therapy* / Q000503:physiopathology; D014549:Urinary Incontinence / Q000453:epidemiology; D014554:Urination / Q000187:drug effects / Q000502:physiology
D001559:Benzhydryl Compounds; D003408:Cresols; D018727:Muscarinic Antagonists; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate; C526675:fesoterodine