Get access

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

Authors


  • Dirk De Ridder led the peer-review process as the Associate Editor responsible for the paper.

  • Conflict of interest: Dana Creanga is an employee of SmithHanley Consulting, who were paid contractors to Pfizer in the development of this manuscript and statistical analysis plan for the pooled statistical analysis of the two studies. Catherine DuBeau has no conflicts to declare. Stephen Kraus serves as a consultant for Pfizer, Allergan, Merck and as Course Director/Faculty for Laborie Medical. Jon D. Morrow was an employee of Pfizer Inc when this study was conducted. Tamara Bavendam is an employee of Pfizer Inc.

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. Neurourol. Urodynam. 31:1258–1265, 2012. © 2012 Wiley Periodicals, Inc.

Ancillary