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Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder.
Eur Urol. 2007 Oct; 52(4):1204-12.EU

Abstract

OBJECTIVE

To determine the efficacy, tolerability, and safety of fesoterodine in subjects with overactive bladder (OAB).

METHODS

This was a multicentre, randomised, double-blind, placebo- and active-controlled trial with tolterodine extended release (ER) to assess the efficacy and safety of fesoterodine. Eligible subjects (> or =18 yr) with increased micturition frequency and urgency and/or urgency urinary incontinence (UUI) were randomised to placebo, fesoterodine 4 mg, fesoterodine 8 mg, or tolterodine ER 4 mg for 12 wk. The primary efficacy variable was a change from baseline to week 12 in micturitions per 24 h. Co-primary end points included change from baseline to week 12 in UUI episodes per 24 h and Treatment Response ("yes" or "no," based on four-point treatment benefit scale). Secondary efficacy variables included mean volume voided per micturition, continent days per week, and number of urgency episodes.

RESULTS

At the end of treatment, subjects taking fesoterodine 4 and 8 mg had significant (p<0.05) and clinically relevant improvements versus placebo in the primary, co-primary, and most secondary efficacy variables. Tolterodine ER (active control) also provided significantly greater improvement than placebo for most efficacy variables, confirming the sensitivity of the study design. A more pronounced effect was observed with fesoterodine 8 mg at most end points.

CONCLUSIONS

Both doses of fesoterodine were significantly better than placebo in improving the symptoms of OAB and produced a significantly greater Treatment Response versus placebo. Efficacy was more pronounced with fesoterodine 8 mg compared with the other treatments. Active treatments were well tolerated.

Authors+Show Affiliations

The Royal Hallamshire Hospital, Sheffield, UK. c.r.chapple@shef.ac.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17651893

Citation

Chapple, Christopher, et al. "Clinical Efficacy, Safety, and Tolerability of Once-daily Fesoterodine in Subjects With Overactive Bladder." European Urology, vol. 52, no. 4, 2007, pp. 1204-12.
Chapple C, Van Kerrebroeck P, Tubaro A, et al. Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder. Eur Urol. 2007;52(4):1204-12.
Chapple, C., Van Kerrebroeck, P., Tubaro, A., Haag-Molkenteller, C., Forst, H. T., Massow, U., Wang, J., & Brodsky, M. (2007). Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder. European Urology, 52(4), 1204-12.
Chapple C, et al. Clinical Efficacy, Safety, and Tolerability of Once-daily Fesoterodine in Subjects With Overactive Bladder. Eur Urol. 2007;52(4):1204-12. PubMed PMID: 17651893.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder. AU - Chapple,Christopher, AU - Van Kerrebroeck,Philip, AU - Tubaro,Andrea, AU - Haag-Molkenteller,Cornelia, AU - Forst,Hans-Theo, AU - Massow,Ute, AU - Wang,Joseph, AU - Brodsky,Marina, Y1 - 2007/07/17/ PY - 2007/04/19/received PY - 2007/07/06/accepted PY - 2007/7/27/pubmed PY - 2008/2/27/medline PY - 2007/7/27/entrez SP - 1204 EP - 12 JF - European urology JO - Eur. Urol. VL - 52 IS - 4 N2 - OBJECTIVE: To determine the efficacy, tolerability, and safety of fesoterodine in subjects with overactive bladder (OAB). METHODS: This was a multicentre, randomised, double-blind, placebo- and active-controlled trial with tolterodine extended release (ER) to assess the efficacy and safety of fesoterodine. Eligible subjects (> or =18 yr) with increased micturition frequency and urgency and/or urgency urinary incontinence (UUI) were randomised to placebo, fesoterodine 4 mg, fesoterodine 8 mg, or tolterodine ER 4 mg for 12 wk. The primary efficacy variable was a change from baseline to week 12 in micturitions per 24 h. Co-primary end points included change from baseline to week 12 in UUI episodes per 24 h and Treatment Response ("yes" or "no," based on four-point treatment benefit scale). Secondary efficacy variables included mean volume voided per micturition, continent days per week, and number of urgency episodes. RESULTS: At the end of treatment, subjects taking fesoterodine 4 and 8 mg had significant (p<0.05) and clinically relevant improvements versus placebo in the primary, co-primary, and most secondary efficacy variables. Tolterodine ER (active control) also provided significantly greater improvement than placebo for most efficacy variables, confirming the sensitivity of the study design. A more pronounced effect was observed with fesoterodine 8 mg at most end points. CONCLUSIONS: Both doses of fesoterodine were significantly better than placebo in improving the symptoms of OAB and produced a significantly greater Treatment Response versus placebo. Efficacy was more pronounced with fesoterodine 8 mg compared with the other treatments. Active treatments were well tolerated. SN - 0302-2838 UR - https://www.unboundmedicine.com/medline/citation/17651893/Clinical_efficacy_safety_and_tolerability_of_once_daily_fesoterodine_in_subjects_with_overactive_bladder_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0302-2838(07)00915-3 DB - PRIME DP - Unbound Medicine ER -