Abstract | BACKGROUND: METHODS: Data from subjects enrolled in double-blind, placebo-controlled phase II and III trials were used for developing longitudinal dose-response models. RESULTS: The models predicted that clinically significant and near-maximum treatment effects would be seen within 3 to 4 weeks after treatment initiation. For a typical patient with 11 micturitions per 24 hours at baseline, predicted change was -1.2, -1.7, and -2.2 micturitions for placebo and fesoterodine 4 mg and 8 mg, respectively. For a typical patient with 2 UUI episodes per 24 hours at baseline, predicted change was -1.05, -1.26, and -1.43 UUI episodes for placebo and fesoterodine 4 mg and 8 mg, respectively. Increase in mean voided volume was estimated at 9.7 mL for placebo, with an additional 14.2 mL and 28.4 mL for fesoterodine 4 mg and 8 mg, respectively. CONCLUSIONS: A consistent dose response for fesoterodine was demonstrated for bladder diary endpoints in subjects with overactive bladder, a result that supports the greater efficacy seen with fesoterodine 8 mg in post hoc analyses of clinical trial data. The dose-response models can be used to predict outcomes for doses not studied or for patient subgroups underrepresented in clinical trials. TRIAL REGISTRATION: The phase III trials used in this analysis have been registered at ClinicalTrials.gov (NCT00220363 and NCT00138723).
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Authors | Linda Cardozo, Vik Khullar, Ahmed El-Tahtawy, Zhonghong Guan, Bimal Malhotra, David Staskin |
Journal | BMC urology
(BMC Urol)
Vol. 10
Pg. 14
(Aug 19 2010)
ISSN: 1471-2490 [Electronic] England |
PMID | 20723260
(Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Benzhydryl Compounds
- Muscarinic Antagonists
- fesoterodine
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Topics |
- Aged
- Benzhydryl Compounds
(administration & dosage)
- Computer Simulation
- Dose-Response Relationship, Drug
- Female
- Humans
- Male
- Muscarinic Antagonists
(administration & dosage)
- Treatment Outcome
- Urinary Bladder, Overactive
(drug therapy, etiology, urine)
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