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Fesoterodine in patients with overactive bladder syndrome: can the severity of baseline urgency urinary incontinence predict dosing requirement?
BJU Int. 2010 Sep; 106(6):816-21.BI

Abstract

OBJECTIVES

To determine whether baseline urgency urinary incontinence (UUI) episodes predict the need for increased doses of fesoterodine in patients with overactive bladder (OAB), as clinicians would benefit from data that help to predict which patients require higher doses of antimuscarinics to manage UUI episodes.

PATIENTS AND METHODS

In this pooled analysis of data from two double-blind, placebo-controlled trials, patients were randomized to placebo or fesoterodine 4 or 8 mg for 12 weeks and stratified into tertiles (>0-<2, 2-<4, or > or =4) according to the number of UUI episodes/24 h as recorded in 3-day bladder diaries at baseline. The change in mean UUI episodes/24 h from baseline to end of study was assessed using analysis of covariance.

RESULTS

In a post hoc analysis of data from two clinical trials, there were significant reductions from baseline in UUI episodes for fesoterodine 4 and 8 mg vs placebo in patients (n) with >0-<2 (422), 2-<4 (424) and > or =4 (481) UUI episodes at baseline (all P < 0.01). In patients with 2-<4 and > or =4 UUI episodes at baseline, fesoterodine 8 mg gave significantly greater mean reductions (-1.92 and -4.17, respectively) vs fesoterodine 4 mg (-1.43 and -3.31) (P < 0.05). The most common adverse events were dry mouth (placebo, 8%; fesoterodine 4 mg, 19%; and 8 mg, 35%) and constipation (placebo, 2%; fesoterodine 4 mg, 5%; and 8 mg, 6%).

CONCLUSION

Fesoterodine 4 and 8 mg significantly reduced UUI episodes vs placebo; this effect appeared to be greater with fesoterodine 8 mg in patients with > or =2 UUI episodes/24 h at baseline. Fesoterodine was well tolerated, although higher doses increased the incidence of adverse events. These findings might aid the clinical identification of patients with OAB who would most benefit from increasing the dose of fesoterodine from 4 to 8 mg.

Authors+Show Affiliations

King's College Hospital, Imperial College, London, UK. lcardozo@compuserve.comNo 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

20151972

Citation

Cardozo, Linda, et al. "Fesoterodine in Patients With Overactive Bladder Syndrome: Can the Severity of Baseline Urgency Urinary Incontinence Predict Dosing Requirement?" BJU International, vol. 106, no. 6, 2010, pp. 816-21.
Cardozo L, Khullar V, Wang JT, et al. Fesoterodine in patients with overactive bladder syndrome: can the severity of baseline urgency urinary incontinence predict dosing requirement? BJU Int. 2010;106(6):816-21.
Cardozo, L., Khullar, V., Wang, J. T., Guan, Z., & Sand, P. K. (2010). Fesoterodine in patients with overactive bladder syndrome: can the severity of baseline urgency urinary incontinence predict dosing requirement? BJU International, 106(6), 816-21. https://doi.org/10.1111/j.1464-410X.2010.09202.x
Cardozo L, et al. Fesoterodine in Patients With Overactive Bladder Syndrome: Can the Severity of Baseline Urgency Urinary Incontinence Predict Dosing Requirement. BJU Int. 2010;106(6):816-21. PubMed PMID: 20151972.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Fesoterodine in patients with overactive bladder syndrome: can the severity of baseline urgency urinary incontinence predict dosing requirement? AU - Cardozo,Linda, AU - Khullar,Vik, AU - Wang,Joseph T, AU - Guan,Zhonghong, AU - Sand,Peter K, Y1 - 2010/02/11/ PY - 2010/2/16/entrez PY - 2010/2/16/pubmed PY - 2010/10/12/medline SP - 816 EP - 21 JF - BJU international JO - BJU Int VL - 106 IS - 6 N2 - OBJECTIVES: To determine whether baseline urgency urinary incontinence (UUI) episodes predict the need for increased doses of fesoterodine in patients with overactive bladder (OAB), as clinicians would benefit from data that help to predict which patients require higher doses of antimuscarinics to manage UUI episodes. PATIENTS AND METHODS: In this pooled analysis of data from two double-blind, placebo-controlled trials, patients were randomized to placebo or fesoterodine 4 or 8 mg for 12 weeks and stratified into tertiles (>0-<2, 2-<4, or > or =4) according to the number of UUI episodes/24 h as recorded in 3-day bladder diaries at baseline. The change in mean UUI episodes/24 h from baseline to end of study was assessed using analysis of covariance. RESULTS: In a post hoc analysis of data from two clinical trials, there were significant reductions from baseline in UUI episodes for fesoterodine 4 and 8 mg vs placebo in patients (n) with >0-<2 (422), 2-<4 (424) and > or =4 (481) UUI episodes at baseline (all P < 0.01). In patients with 2-<4 and > or =4 UUI episodes at baseline, fesoterodine 8 mg gave significantly greater mean reductions (-1.92 and -4.17, respectively) vs fesoterodine 4 mg (-1.43 and -3.31) (P < 0.05). The most common adverse events were dry mouth (placebo, 8%; fesoterodine 4 mg, 19%; and 8 mg, 35%) and constipation (placebo, 2%; fesoterodine 4 mg, 5%; and 8 mg, 6%). CONCLUSION: Fesoterodine 4 and 8 mg significantly reduced UUI episodes vs placebo; this effect appeared to be greater with fesoterodine 8 mg in patients with > or =2 UUI episodes/24 h at baseline. Fesoterodine was well tolerated, although higher doses increased the incidence of adverse events. These findings might aid the clinical identification of patients with OAB who would most benefit from increasing the dose of fesoterodine from 4 to 8 mg. SN - 1464-410X UR - https://www.unboundmedicine.com/medline/citation/20151972/Fesoterodine_in_patients_with_overactive_bladder_syndrome:_can_the_severity_of_baseline_urgency_urinary_incontinence_predict_dosing_requirement L2 - https://doi.org/10.1111/j.1464-410X.2010.09202.x DB - PRIME DP - Unbound Medicine ER -