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Efficacy and tolerability of fesoterodine versus tolterodine in older and younger subjects with overactive bladder: a post hoc, pooled analysis from two placebo-controlled trials.
Neurourol Urodyn. 2012 Nov; 31(8):1258-65.NU

Abstract

AIMS

To assess the efficacy and tolerability of fesoterodine 8 mg versus tolterodine extended release (ER) 4 mg in subjects with overactive bladder (OAB) stratified by age (<65, 65-74, and ≥75 years).

METHODS

This was a post hoc analysis of data from two double-blind trials. Subjects reporting ≥1 urgency urinary incontinence (UUI) episode and ≥8 micturitions/24 hr at baseline were randomized to fesoterodine (4 mg for 1 week, 8 mg for 11 weeks), tolterodine ER 4 mg, or placebo. Subjects completed 3-day bladder diaries, Urgency Perception Scale (UPS), Patient Perception of Bladder Condition (PPBC), and OAB questionnaire (OAB-q) at baseline and week 12. The primary endpoint in both studies was change from baseline to week 12 in UUI episodes.

RESULTS

Among subjects <65 years (n = 2,670), improvements in UUI episodes, micturitions, urgency episodes, severe urgency episodes, frequency-urgency sum, UPS, PPBC, and all OAB-q scales and domains were significantly greater with fesoterodine versus tolterodine ER, and diary-dry rates were significantly higher. Among subjects 65-74 years (n = 990), improvements in mean voided volume per void, PPBC, and OAB-q Symptom Bother and Coping were significantly greater with fesoterodine versus tolterodine ER. Among subjects aged ≥75 years (n = 448), improvements in urgency episodes, severe urgency episodes, frequency-urgency sum, UPS, and OAB-q Symptom Bother were significantly greater with fesoterodine versus tolterodine ER. Both active treatments produced significant improvements in most outcomes versus placebo across age groups. Adverse event rates were similar among age groups.

CONCLUSIONS

Fesoterodine 8 mg consistently improved several OAB-related variables versus tolterodine ER 4 mg in subjects aged <65, 65-74, and ≥75 years, with some differences reaching statistical significance, and was generally well tolerated.

Authors+Show Affiliations

University of Massachusetts Medical School and UMassMemorial Medical Center, Worcester, Massachusetts 01605, USA. catherine.dubeau@umassmemorial.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22907761

Citation

DuBeau, Catherine E., et al. "Efficacy and Tolerability of Fesoterodine Versus Tolterodine in Older and Younger Subjects With Overactive Bladder: a Post Hoc, Pooled Analysis From Two Placebo-controlled Trials." Neurourology and Urodynamics, vol. 31, no. 8, 2012, pp. 1258-65.
DuBeau CE, Morrow JD, Kraus SR, et al. Efficacy and tolerability of fesoterodine versus tolterodine in older and younger subjects with overactive bladder: a post hoc, pooled analysis from two placebo-controlled trials. Neurourol Urodyn. 2012;31(8):1258-65.
DuBeau, C. E., Morrow, J. D., Kraus, S. R., Creanga, D., & Bavendam, T. (2012). Efficacy and tolerability of fesoterodine versus tolterodine in older and younger subjects with overactive bladder: a post hoc, pooled analysis from two placebo-controlled trials. Neurourology and Urodynamics, 31(8), 1258-65. https://doi.org/10.1002/nau.22252
DuBeau CE, et al. Efficacy and Tolerability of Fesoterodine Versus Tolterodine in Older and Younger Subjects With Overactive Bladder: a Post Hoc, Pooled Analysis From Two Placebo-controlled Trials. Neurourol Urodyn. 2012;31(8):1258-65. PubMed PMID: 22907761.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of fesoterodine versus tolterodine in older and younger subjects with overactive bladder: a post hoc, pooled analysis from two placebo-controlled trials. AU - DuBeau,Catherine E, AU - Morrow,Jon D, AU - Kraus,Stephen R, AU - Creanga,Dana, AU - Bavendam,Tamara, Y1 - 2012/08/20/ PY - 2011/11/07/received PY - 2012/03/12/accepted PY - 2012/8/22/entrez PY - 2012/8/22/pubmed PY - 2013/4/10/medline SP - 1258 EP - 65 JF - Neurourology and urodynamics JO - Neurourol. Urodyn. VL - 31 IS - 8 N2 - AIMS: To assess the efficacy and tolerability of fesoterodine 8 mg versus tolterodine extended release (ER) 4 mg in subjects with overactive bladder (OAB) stratified by age (<65, 65-74, and ≥75 years). METHODS: This was a post hoc analysis of data from two double-blind trials. Subjects reporting ≥1 urgency urinary incontinence (UUI) episode and ≥8 micturitions/24 hr at baseline were randomized to fesoterodine (4 mg for 1 week, 8 mg for 11 weeks), tolterodine ER 4 mg, or placebo. Subjects completed 3-day bladder diaries, Urgency Perception Scale (UPS), Patient Perception of Bladder Condition (PPBC), and OAB questionnaire (OAB-q) at baseline and week 12. The primary endpoint in both studies was change from baseline to week 12 in UUI episodes. RESULTS: Among subjects <65 years (n = 2,670), improvements in UUI episodes, micturitions, urgency episodes, severe urgency episodes, frequency-urgency sum, UPS, PPBC, and all OAB-q scales and domains were significantly greater with fesoterodine versus tolterodine ER, and diary-dry rates were significantly higher. Among subjects 65-74 years (n = 990), improvements in mean voided volume per void, PPBC, and OAB-q Symptom Bother and Coping were significantly greater with fesoterodine versus tolterodine ER. Among subjects aged ≥75 years (n = 448), improvements in urgency episodes, severe urgency episodes, frequency-urgency sum, UPS, and OAB-q Symptom Bother were significantly greater with fesoterodine versus tolterodine ER. Both active treatments produced significant improvements in most outcomes versus placebo across age groups. Adverse event rates were similar among age groups. CONCLUSIONS: Fesoterodine 8 mg consistently improved several OAB-related variables versus tolterodine ER 4 mg in subjects aged <65, 65-74, and ≥75 years, with some differences reaching statistical significance, and was generally well tolerated. SN - 1520-6777 UR - https://www.unboundmedicine.com/medline/citation/22907761/Efficacy_and_tolerability_of_fesoterodine_versus_tolterodine_in_older_and_younger_subjects_with_overactive_bladder:_a_post_hoc_pooled_analysis_from_two_placebo_controlled_trials_ L2 - https://doi.org/10.1002/nau.22252 DB - PRIME DP - Unbound Medicine ER -