Efficacy of fesoterodine over 24 hours in subjects with overactive bladder.
Objective: Fesoterodine is an antimuscarinic agent indicated for the treatment of overactive bladder (OAB) symptoms. The objective of this study was to evaluate the efficacy of fesoterodine versus placebo over selected intervals during a 24-hour period in subjects with OAB.Research Design and Method...
| Publicado en: | Current Medical Research & Opinion Vol. 26; no. 4; pp. 813 - 819 |
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| Autores principales: | , , , , , |
| Formato: | research Journal Article |
| Publicado: |
Taylor & Francis Ltd
Jan2010
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=104641696&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 104641696 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 03007995 DFY jtl: Current Medical Research & Opinion issn: 03007995 maglogo: N pubinfo: dt: Jan2010 vid: 26 iid: 4 pid: 377 pub: Taylor & Francis Ltd place: Philadelphia, Pennsylvania artinfo: ui: 104641696 NLM20121659 2011381931 10.1185/03007990903585707 NLM20121659 104641696 ppf: 813 ppct: 6 formats: tig: atl: Efficacy of fesoterodine over 24 hours in subjects with overactive bladder. aug: au: Staskin, David Michel, Martin C Nitti, Victor Morrow, Jon D Wang, Joseph Guan, Zhonghong affil: Tufts University School of Medicine, Boston, MA 02135, USA. staskin@att.net sug: subj: Benzhydryl Compounds Therapeutic Use Muscarinic Antagonists Therapeutic Use Overactive Bladder Drug Therapy Adult Aged Aged, 80 and Over Benzhydryl Compounds Administration and Dosage Benzhydryl Compounds Pharmacodynamics Dose-Response Relationship, Drug Drug Administration Schedule Female Regression Male Middle Age Muscarinic Antagonists Administration and Dosage Muscarinic Antagonists Pharmacodynamics Clinical Trials Adult: 19-44 years Aged: 65+ years Aged, 80 & over Middle Aged: 45-64 years Female Male ab: Objective: Fesoterodine is an antimuscarinic agent indicated for the treatment of overactive bladder (OAB) symptoms. The objective of this study was to evaluate the efficacy of fesoterodine versus placebo over selected intervals during a 24-hour period in subjects with OAB.Research Design and Methods: In a post hoc analysis, data were analyzed from two randomized, double-blind, placebo-controlled 12-week phase III trials in which subjects with a history of OAB symptoms for >or=6 months were treated with morning doses of fesoterodine 4 mg, fesoterodine 8 mg, or placebo.Clinical Trial Registration: These trials are registered at ClinicalTrials.gov (NCT00220363 and NCT00138723).Main Outcome Measures: Changes were evaluated in number of micturitions, urgency episodes, urgency urinary incontinence (UUI) episodes, and mean voided volume (MVV) divided into three 8-hour intervals: 08:00-15:59 (daytime), 16:00-23:59 (evening), and 00:00-07:59 (nighttime). Comparisons with placebo were made using analysis of covariance (for least squares mean changes) and Wilcoxon rank sum test (for median percent changes); differences were considered significant at p < 0.05.Results: Data from 1674 subjects, 80% of whom were women, were included in the analysis. At the end of treatment, the least squares mean change from baseline for all efficacy endpoints was significantly greater with fesoterodine 4 mg and fesoterodine 8 mg compared with placebo during each 8-hour time interval (all p < 0.05). Median percent change in number of micturitions, urgency episodes, and UUI episodes also was significantly greater with both fesoterodine doses compared with placebo during all time intervals (all p < 0.05).Conclusions: Fesoterodine 4 mg and 8 mg given once daily demonstrated efficacy over placebo for OAB symptoms during all three 8-hour intervals of a 24-hour period, thus providing clinical support for once-daily dosing. Limitations include that this was a post hoc analysis. pubtype: Academic Journal doctype: research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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