Early onset of fesoterodine efficacy in subjects with overactive bladder.

Abstract

OBJECTIVE:

To assess the onset of efficacy of fesoterodine 4 mg once daily on overactive bladder (OAB) symptoms after 1 week of treatment.

PATIENTS AND METHODS:

This was a prespecified analysis of data collected during the first week of a 12-week, open-label, single-arm, flexible-dose study of fesoterodine. Eligible subjects were adult men and women (aged ≥ 18 years) who reported urinary frequency (eight or more micturitions per 24 h) and urgency (three or more episodes per 24 h) in 5-day bladder diaries at baseline, and dissatisfaction with previous tolterodine or tolterodine extended-release treatment received within 2 years of screening. All subjects received fesoterodine 4 mg once daily during the first 4 weeks of treatment (with an optional dose increase to fesoterodine 8 mg after week 4). Early onset of efficacy of fesoterodine 4 mg was assessed based on changes from baseline to week 1 in variables recorded in 5-day bladder diaries, including total micturitions, urgency episodes, urgency urinary incontinence (UUI) episodes and nocturnal micturitions. Urgency and severe urgency episodes were defined as those rated ≥ 3 and ≥ 4, respectively, on the five-point Urinary Sensation Scale (USS) (1 = no urgency, 5 = UUI); frequency-urgency sum (a combined measure of micturition frequency and urgency) was defined as the sum of all USS ratings.

RESULTS:

All bladder diary variables, including total and nocturnal micturitions, UUI episodes, urgency episodes, severe urgency episodes and frequency-urgency sum per 24 h, were significantly improved (all P < 0.0001) after 1 week of treatment with fesoterodine 4 mg compared to baseline. The diary-dry rate at week 1 (i.e. subjects with at least one UUI episode at baseline who subsequently reported no UUI episodes on week 1 diary) was 38%.

CONCLUSION:

In this open-label study of subjects with OAB who had been previously treated and dissatisfied with tolterodine, fesoterodine 4 mg showed a rapid onset of efficacy at 1 week.

• Authors: Howard B Goldman, Jon D Morrow, Jason Gong, Li-Jung Tseng, Tim Schneider
• Journal: BJU international (BJU Int) Vol. 107 Issue 4 Pg. 598-602 (Feb 2011) ISSN: 1464-410X [Electronic] England
• PMID: 20868387 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: © 2010 THE AUTHORS. JOURNAL COMPILATION © 2010 BJU INTERNATIONAL.

Chemical References

• Benzhydryl Compounds
• Muscarinic Antagonists
• fesoterodine

Topics

• Adult
• Aged
• Aged, 80 and over
• Benzhydryl Compounds (administration & dosage, therapeutic use)
• Dose-Response Relationship, Drug
• Epidemiologic Methods
• Female
• Humans
• Male
• Middle Aged
• Muscarinic Antagonists (administration & dosage, therapeutic use)
• Patient Satisfaction
• Treatment Outcome
• Urinary Bladder, Overactive (drug therapy)
• Young Adult