Efficacy and tolerability of fesoterodine in older and younger subjects with overactive bladder.
OBJECTIVE
To assess the effect of age on fesoterodine efficacy and tolerability in subjects with an overactive bladder.


METHODS
The data from 2 randomized, 12-week studies of 1681 subjects treated with fesoterodine 4 or 8 mg or placebo were pooled and stratified by age. The subjects completed 3-day bladder diaries at baseline and weeks 2 and 12, the King's Health Questionnaire at baseline and week 12, and the Treatment Benefit Scale at week 12.


RESULTS
Of the subjects aged <65 years, fesoterodine 4 and 8 mg was associated with statistically significant improvements in the diary variables at week 12 versus placebo. Greater improvement in urgency urinary incontinence was seen with fesoterodine 8 mg versus 4 mg. For those aged ≥65 to <75 years, fesoterodine 4 and 8 mg significantly improved all diary variables, except for the mean voided volume and micturition frequency, respectively, [corrected] versus placebo. In subjects aged ≥75 years, fesoterodine 8 mg significantly improved all diary variables, except for mean voided volume, versus placebo. No significant improvements were observed with fesoterodine 4 mg versus placebo. Fesoterodine significantly improved several King's Health Questionnaire domains versus placebo in all age groups. Fesoterodine 4 mg did not significantly improve any domains in subjects aged ≥75 years. In all age groups, the treatment response rates were significantly greater with both fesoterodine doses versus placebo. Dry mouth and constipation occurred more frequently in subjects aged ≥75 years receiving fesoterodine 8 mg than in those receiving fesoterodine 4 mg or placebo, although the discontinuation rates because of dry mouth and constipation were not increased.


CONCLUSIONS
Fesoterodine 4 and 8 mg effectively treated overactive bladder symptoms in subjects aged <75 years. Fesoterodine 8 mg was effective in subjects aged ≥75 years.
Kraus
Stephen R
SR
University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.
Ruiz-Cerdá
José Luis
JL
Martire
Diane
D
Wang
Joseph T
JT
Wagg
Adrian S
AS
D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D001559:Benzhydryl Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003248:Constipation / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010352:Patient Dropouts; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D011795:Surveys and Questionnaires; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*; D053202:Urinary Incontinence, Urge / Q000188:drug therapy; D014987:Xerostomia / Q000139:chemically induced; D055815:Young Adult
D001559:Benzhydryl Compounds; D018727:Muscarinic Antagonists; C526675:fesoterodine