Efficacy, safety and tolerability of fesoterodine for overactive bladder syndrome.
OBJECTIVE
We evaluated the efficacy, tolerability and safety of the new antimuscarinic agent fesoterodine relative to placebo for overactive bladder syndrome.


METHODS
This was a randomized, double-blind, placebo controlled, multicenter trial performed in the United States. Overall 836 subjects with urinary frequency, urinary urgency or urgency urinary incontinence were randomized to placebo (274), 4 mg fesoterodine (283) or 8 mg fesoterodine (279) once daily for 12 weeks. The primary efficacy end point was the change in the number of micturitions per 24 hours. Co-primary end points were the change in the number of urgency urinary incontinence episodes per 24 hours and the treatment response. Secondary efficacy end points were other bladder diary variables, such as the change in mean voided volume per micturition, number of continent days and number of urgency episodes per 24 hours. Tolerability and safety were assessed by evaluating adverse events, electrocardiograms, post-void residual urine volume, laboratory parameters and treatment withdrawals.


RESULTS
Treatment with 4 or 8 mg fesoterodine resulted in statistically significant and clinically relevant improvements from baseline to end of treatment for the primary and co-primary end points compared with placebo (p <0.05). Results for most secondary end points, including mean voided volume per micturition, number of continent days and number of urgency episodes per 24 hours, were also significantly improved vs placebo. The adverse events reported more frequently with fesoterodine than with placebo were dry mouth, constipation and urinary tract infection.


CONCLUSIONS
The 2 doses of fesoterodine were well tolerated and they statistically significantly improved overactive bladder symptoms.
Nitti
Victor W
VW
Department of Urology, New York University School of Medicine, New York, New York 10016, USA. Victor.Nitti@nyumc.org
Dmochowski
Roger
R
Sand
Peter K
PK
Forst
Hans-Theo
HT
Haag-Molkenteller
Cornelia
C
Massow
Ute
U
Wang
Joseph
J
Brodsky
Marina
M
Bavendam
Tamara
T
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D015999:Multivariate Analysis; D018727:Muscarinic Antagonists / Q000008:administration & dosage*; D011336:Probability; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000175:diagnosis / Q000188:drug therapy*; D014563:Urodynamics
D018727:Muscarinic Antagonists