Abstract | OBJECTIVE: • To show the superior efficacy of fesoterodine over tolterodine extended release (ER) in a placebo-controlled overactive bladder (OAB) trial with predefined treatment comparisons for both diary measures and patient-reported outcomes. MATERIALS AND METHODS: • In this 12-week, double-blind, double-dummy trial, subjects reporting >1 urgency urinary incontinence (UUI) episode and ≥8 micturitions per 24 h at baseline were randomized to fesoterodine (4 mg for 1 week, 8 mg for 11 weeks), tolterodine ER 4 mg, or placebo. • Subjects completed 3-day bladder diaries, the Patient Perception of Bladder Condition (PPBC) and the Urgency Perception Scale (UPS) at baseline and weeks 1, 4 and 12 and the OAB Questionnaire at baseline and week 12. RESULTS: • A total of 2417 subjects were randomized. At week 12, fesoterodine 8 mg showed superiority over tolterodine ER 4 mg and placebo on UUI episodes (primary endpoint), micturitions, urgency and most other diary endpoints, and on the PPBC, UPS and all OAB Questionnaire scales and domains (all P < 0.05). • Superiority of fesoterodine 8 mg over tolterodine ER 4 mg was seen as early as week 4 (3 weeks after escalation to fesoterodine 8 mg). At week 1, fesoterodine 4 mg was superior to placebo on most diary variables, the PPBC and the UPS (all P < 0.05). Dry mouth and constipation rates were 28% and 4% with fesoterodine, 13% and 3% with tolterodine ER, and 5% and 2% with placebo. • Discontinuation rates as a result of adverse events were 5%, 3% and 2% for fesoterodine, tolterodine ER and placebo, respectively. CONCLUSIONS: • In this randomized study, which is the largest to compare antimuscarinic efficacy performed to date, fesoterodine 8 mg was superior to tolterodine ER 4 mg for UUI episodes, micturitions and urgency episodes, as well as for self-reported patient assessments of bladder-related problems, urgency, symptom bother and health-related quality of life. • The superiority of fesoterodine 8 mg over tolterodine ER 4 mg was observed as early as 3 weeks after escalation from fesoterodine 4 mg for most outcomes. These data may have important implications for the clinical management of OAB patients previously treated with tolterodine ER.
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Authors | Steven A Kaplan, Tim Schneider, Jenelle E Foote, Zhonghong Guan, Martin Carlsson, Jason Gong |
Journal | BJU international
(BJU Int)
Vol. 107
Issue 9
Pg. 1432-40
(May 2011)
ISSN: 1464-410X [Electronic] England |
PMID | 20860717
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2010 THE AUTHORS. BJU INTERNATIONAL © 2010 BJU INTERNATIONAL. |
Chemical References |
- Benzhydryl Compounds
- Cresols
- Delayed-Action Preparations
- Muscarinic Antagonists
- Phenylpropanolamine
- Tolterodine Tartrate
- fesoterodine
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Benzhydryl Compounds
(administration & dosage, therapeutic use)
- Cresols
(administration & dosage, therapeutic use)
- Delayed-Action Preparations
- Epidemiologic Methods
- Female
- Humans
- Male
- Middle Aged
- Muscarinic Antagonists
(administration & dosage, therapeutic use)
- Phenylpropanolamine
(administration & dosage, therapeutic use)
- Quality of Life
- Tolterodine Tartrate
- Treatment Outcome
- Urinary Bladder, Overactive
(complications, drug therapy)
- Urinary Incontinence, Urge
(drug therapy, etiology)
- Young Adult
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