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Comparison of fesoterodine and tolterodine in patients with overactive bladder.
BJU Int. 2008 Nov; 102(9):1128-32.BI

Abstract

OBJECTIVE

To compare, in a post hoc analysis of a phase III trial, the maximum recommended doses of fesoterodine (8 mg) and tolterodine (4 mg) for improving overactive bladder (OAB) symptoms and health-related quality of life (HRQoL), as fesoterodine effectively reduces OAB symptoms vs placebo.

PATIENTS AND METHODS

Eligible patients with frequency (> or =eight voids/24 h) and either urgency (> or =six episodes over 3 days) or urgency urinary incontinence (UUI; > or =three episodes over 3 days) were randomized to placebo, fesoterodine 4 or 8 mg, or tolterodine extended-release (ER) 4 mg for 12 weeks; fesoterodine 4 mg data were published elsewhere. Patients completed a 3-day bladder diary in which they recorded the time of each void, voided volume (VV), and the severity of urgency. A post hoc inferential analysis was conducted on the primary endpoint (voids/24 h), the two co-primary endpoints (UUI episodes/24 h and treatment response), several secondary endpoints (severe urgency plus UUI per 24 h, mean VV (MVV)/void, and continent days/week), HRQoL, using the King's Health Questionnaire (KHQ) and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and self-reported bladder-related problems. A subanalysis also assessed all endpoints for patients who were incontinent at baseline. Tolerability and safety were assessed by evaluating adverse events, residual urine volume, laboratory variables and treatment withdrawals.

RESULTS

By week 12, patients with OAB in both active-treatment groups showed significant improvements in most bladder diary variables and treatment response rates compared with placebo. Fesoterodine 8 mg was statistically significantly better than tolterodine ER 4 mg for improving UUI episodes, severe urgency plus UUI, mean VV, and number of continent days/week. In addition, the fesoterodine and tolterodine ER groups showed significantly greater improvements in HRQoL than the placebo group, with positive changes in most domains of the KHQ and an improvement in ICIQ-SF score. The fesoterodine 8-mg group had statistically significant improvements over placebo in eight of nine KHQ domains. A major improvement in the severity of bladder-related problems was reported by 39% of the fesoterodine 8 mg and 34% of the tolterodine ER groups vs 25% of those on placebo (P < or = 0.01). Results for the subgroup of incontinent patients at baseline were similar to the overall results. Adverse events reported most commonly with active treatment included dry mouth, constipation, dry eye, dry throat, and nausea.

CONCLUSIONS

Both fesoterodine and tolterodine ER significantly improved OAB symptoms and HRQoL, with statistically significant advantages for fesoterodine 8 mg compared with tolterodine ER on several important endpoints.

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 available

Pub Type(s)

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

Language

eng

PubMed ID

18647298

Citation

Chapple, Christopher R., et al. "Comparison of Fesoterodine and Tolterodine in Patients With Overactive Bladder." BJU International, vol. 102, no. 9, 2008, pp. 1128-32.
Chapple CR, Van Kerrebroeck PE, Jünemann KP, et al. Comparison of fesoterodine and tolterodine in patients with overactive bladder. BJU Int. 2008;102(9):1128-32.
Chapple, C. R., Van Kerrebroeck, P. E., Jünemann, K. P., Wang, J. T., & Brodsky, M. (2008). Comparison of fesoterodine and tolterodine in patients with overactive bladder. BJU International, 102(9), 1128-32. https://doi.org/10.1111/j.1464-410X.2008.07907.x
Chapple CR, et al. Comparison of Fesoterodine and Tolterodine in Patients With Overactive Bladder. BJU Int. 2008;102(9):1128-32. PubMed PMID: 18647298.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of fesoterodine and tolterodine in patients with overactive bladder. AU - Chapple,Christopher R, AU - Van Kerrebroeck,Philip E, AU - Jünemann,Klaus-Peter, AU - Wang,Joseph T, AU - Brodsky,Marina, Y1 - 2008/07/21/ PY - 2008/7/24/pubmed PY - 2009/1/1/medline PY - 2008/7/24/entrez SP - 1128 EP - 32 JF - BJU international JO - BJU Int. VL - 102 IS - 9 N2 - OBJECTIVE: To compare, in a post hoc analysis of a phase III trial, the maximum recommended doses of fesoterodine (8 mg) and tolterodine (4 mg) for improving overactive bladder (OAB) symptoms and health-related quality of life (HRQoL), as fesoterodine effectively reduces OAB symptoms vs placebo. PATIENTS AND METHODS: Eligible patients with frequency (> or =eight voids/24 h) and either urgency (> or =six episodes over 3 days) or urgency urinary incontinence (UUI; > or =three episodes over 3 days) were randomized to placebo, fesoterodine 4 or 8 mg, or tolterodine extended-release (ER) 4 mg for 12 weeks; fesoterodine 4 mg data were published elsewhere. Patients completed a 3-day bladder diary in which they recorded the time of each void, voided volume (VV), and the severity of urgency. A post hoc inferential analysis was conducted on the primary endpoint (voids/24 h), the two co-primary endpoints (UUI episodes/24 h and treatment response), several secondary endpoints (severe urgency plus UUI per 24 h, mean VV (MVV)/void, and continent days/week), HRQoL, using the King's Health Questionnaire (KHQ) and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and self-reported bladder-related problems. A subanalysis also assessed all endpoints for patients who were incontinent at baseline. Tolerability and safety were assessed by evaluating adverse events, residual urine volume, laboratory variables and treatment withdrawals. RESULTS: By week 12, patients with OAB in both active-treatment groups showed significant improvements in most bladder diary variables and treatment response rates compared with placebo. Fesoterodine 8 mg was statistically significantly better than tolterodine ER 4 mg for improving UUI episodes, severe urgency plus UUI, mean VV, and number of continent days/week. In addition, the fesoterodine and tolterodine ER groups showed significantly greater improvements in HRQoL than the placebo group, with positive changes in most domains of the KHQ and an improvement in ICIQ-SF score. The fesoterodine 8-mg group had statistically significant improvements over placebo in eight of nine KHQ domains. A major improvement in the severity of bladder-related problems was reported by 39% of the fesoterodine 8 mg and 34% of the tolterodine ER groups vs 25% of those on placebo (P < or = 0.01). Results for the subgroup of incontinent patients at baseline were similar to the overall results. Adverse events reported most commonly with active treatment included dry mouth, constipation, dry eye, dry throat, and nausea. CONCLUSIONS: Both fesoterodine and tolterodine ER significantly improved OAB symptoms and HRQoL, with statistically significant advantages for fesoterodine 8 mg compared with tolterodine ER on several important endpoints. SN - 1464-410X UR - https://www.unboundmedicine.com/medline/citation/18647298/Comparison_of_fesoterodine_and_tolterodine_in_patients_with_overactive_bladder_ L2 - https://doi.org/10.1111/j.1464-410X.2008.07907.x DB - PRIME DP - Unbound Medicine ER -