Efficacy and tolerability of fesoterodine in women with overactive bladder.
OBJECTIVE
We assessed fesoterodine efficacy and tolerability in women with overactive bladder (OAB).


METHODS
This post hoc analysis of pooled data from two clinical trials included 1,548 women with OAB randomized to placebo, fesoterodine 4 or 8 mg, or tolterodine extended release (ER) 4 mg (in 1 trial) for 12 weeks. Subjects completed 3-day bladder diaries at baseline and weeks 2 and 12 and rated Treatment Response at weeks 2 and 12.


RESULTS
By weeks 2 and 12, all active-treatment groups showed significant improvements in all five bladder diary variables assessed and greater Treatment Response rates vs placebo. Fesoterodine 8 mg was significantly more efficacious than fesoterodine 4 mg and tolterodine ER in improving urgency urinary incontinence episodes and continent days per week. The most common adverse events were dry mouth and constipation, which were predominately mild or moderate.


CONCLUSIONS
Fesoterodine is efficacious and well tolerated in women with OAB.
Sand
Peter K
PK
Evanston Continence Center, Department of Obstetrics and Gynecology, Northwestern University, Feinberg School of Medicine, 1000 Central Street, Suite 730, Evanston, IL 60201, USA. p-sand@northwestern.edu
Morrow
Jon D
JD
Bavendam
Tamara
T
Creanga
Dana L
DL
Nitti
Victor W
VW
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D003248:Constipation / Q000139:chemically induced; D003408:Cresols / Q000009:adverse effects / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D010665:Phenylpropanolamine / Q000009:adverse effects / Q000627:therapeutic use; D000068737:Tolterodine Tartrate; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*
D001559:Benzhydryl Compounds; D003408:Cresols; D018727:Muscarinic Antagonists; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate; C526675:fesoterodine