Results
of the Randomized, Double-Blind, Placebo-Controlled Study of Fesoterodine in an
Aging Population Trial
J Am Geriatr
Soc. 2013;61(2):185-193.
Abstract and Introduction
Abstract
Objectives To assess
the efficacy and safety of flexible-dose fesoterodine in elderly adults with
overactive bladder (OAB).
Design Twelve-week,
randomized, double-blind, placebo-controlled trial.
Setting Sixty-one
outpatient clinics in Europe, Israel, and Turkey.
Participants Seven
hundred ninety-four individuals aged 65 and older (47% male) with OAB symptoms
for 3 months or longer, mean of eight or more micturitions and three or more
urgency episodes per 24 hours, at least some moderate problems on Patient
Perception of Bladder Condition (PPBC), and Mini-Mental State Examination
(MMSE) score of 20 or greater.
Interventions Participants
were randomized to fesoterodine or placebo for 12 weeks, with stratification
according to age (>75 vs ≤75) and dosing time (morning vs evening).
Participants receiving fesoterodine started on 4 mg and could increase to 8 mg
at week 4 or 8 and de-escalate to 4 mg at week 8 (sham escalation for placebo).
Measurements Changes
from baseline in bladder-diary variables (primary endpoint, urgency episodes)
and patient-reported outcomes including OAB Questionnaire, Treatment Benefit
Scale (TBS), PPBC, Urgency Perception Scale (UPS), and OAB Satisfaction
Questionnaire (OAB-S); all observed or reported adverse events.
Results By week
8, 64% of fesoterodine-treated and 71% of placebo-treated participants opted
for dose escalation. At week 12, the fesoterodine group had statistically
significantly greater improvement than the placebo group in urgency episodes,
micturitions, nocturnal micturitions, incontinence pad use, and OAB
Questionnaire scores but not urgency urinary incontinence episodes. Responder
rates on TBS, PPBC, UPS, and OAB-S were statistically significantly higher with
fesoterodine. Improvements in most diary variables and participant-reported
outcomes were greater with fesoterodine than placebo in participants in both
age groups and when administered in the morning and evening. Rates of dry mouth
and constipation were 34% and 9% with fesoterodine and 5% and 3% with placebo,
respectively. Rates of adverse events and discontinuations were generally
similar in participants in both age groups. There was no change in MMSE score.
Conclusion Fesoterodine
was associated with significantly greater improvements in most diary variables
and participant-reported outcomes than placebo and was generally well tolerated
in older people.
call me for full paper: Dr Atef
01224245101
atefmas@yahoo.com
