Long-term safety, tolerability and efficacy of fesoterodine treatment in subjects with overactive bladder symptoms.
OBJECTIVE
The aim of this study was to assess the long-term safety, tolerability and efficacy of fesoterodine treatment in subjects with overactive bladder (OAB) symptoms.


METHODS
This was an open-label extension study of a 12-week, double-blind fesoterodine study. During open-label treatment, all subjects received fesoterodine 8 mg for an initial 4 weeks, after which subjects could elect dose reduction to 4 mg or subsequent reescalation to 8 mg during clinic visits (dose reduction and reescalation each permitted once annually). The maximum allowable duration of open-label fesoterodine treatment ranged from 24 to 32 months across study sites. Safety and tolerability were evaluated via discontinuations, fesoterodine exposure, treatment-emergent adverse events (TEAEs) and subject-reported treatment tolerance. Three-day bladder diaries and other patient-reported outcomes (PROs) were assessed during the first 24 months of open-label treatment. PROs included evaluations of health-related quality of life [HRQL; King's Health Questionnaire (KHQ), and International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)], severity of bladder-related problems and treatment satisfaction. Subjects completed 3-day diaries before open-label baseline and months 1, 4, 8, 12 and 24; the ICIQ-SF and measures of bladder-related problems and treatment satisfaction at open-label baseline and months 4, 12 and 24; and the KHQ at open-label baseline and months 12 and 24.


RESULTS
Of the 417 eligible subjects who enrolled in the open-label extension, 61% continued fesoterodine treatment for > or = 24 months and 71% elected to maintain the fesoterodine 8-mg dose throughout treatment. No unexpected safety signals were observed. Most subjects rated treatment tolerance as at least 'good' throughout the study (> or = 88%). Dry mouth was the most commonly reported TEAE (34%) during open-label treatment, resulting in discontinuation in 2% of subjects (n = 8). Improvements from open-label baseline in OAB symptoms, HRQL and bladder-related problems were statistically significant at the earliest point measured and maintained through month 24. Treatment satisfaction rates were high throughout the study (> or = 84%).


CONCLUSIONS
Long-term fesoterodine treatment was well tolerated and associated with sustained improvements in OAB symptoms and HRQL.
Van Kerrebroeck
P E V
PE
University Hospital Maastricht, the Netherlands. p.vankerrebroeck@mumc.nl <p.vankerrebroeck@mumc.nl>
Heesakkers
J
J
Berriman
S
S
Padmanabhan Aiyer
L
L
Carlsson
M
M
Guan
Z
Z
D000328:Adult; D000368:Aged; D001294:Attitude to Health; D001559:Benzhydryl Compounds / Q000008:administration & dosage / Q000009:adverse effects*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage / Q000009:adverse effects*; D011788:Quality of Life; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy* / Q000523:psychology; D014549:Urinary Incontinence / Q000188:drug therapy / Q000523:psychology
D001559:Benzhydryl Compounds; D018727:Muscarinic Antagonists; C526675:fesoterodine