PARIS, FRANCE (UroToday.com) - The authors' objective was to evaluate treatment response in elderly subjects with overactive bladder (OAB) who did and did not choose to escalate from fesoterodine (FESO) 4 mg to FESO 8 mg, both before and after the dose escalation choice point.
This was a post hoc analysis of data from SOFIA, a 12-week, randomized, double-blind, placebo (PBO)-controlled, flexible-dose trial of FESO in subjects aged ≥65 y with OAB (≥3 urgency episodes and ≥8 micturitions per 24 h). Subjects in the FESO group started on FESO 4 mg with the option to escalate to 8 mg at weeks 4 and 8; those who escalated at week 4 could de-escalate at week 8 (sham escalation for PBO). Subjects completed bladder diaries, Patient Perception of Bladder Condition (PPBC), Urgency Perception Scale (UPS), and Overactive Bladder Questionnaire (OAB-q) at baseline and weeks 4 and 12 (primary endpoint: change from baseline to week 12 in urgency episodes/24 h). Changes from baseline to week 4 were assessed descriptively. Changes from baseline to week 12 for FESO vs. PBO by escalation status were analysed using ANCOVA for diary endpoints and OAB-q scores and logistic regression for PPBC and UPS scores.
Presented by Wagg A,1 Khullar V,2 Oelke M,3 Marschall-Kehre D,4 Michel MC,5 Darekar A,6 Ebel-Bitoun C,7 at the 27th Annual European Association of Urology (EAU) Congress - February 24 - 28, 2012 - Le Palais des Congrès de Paris, Paris, France
1University of Alberta, Dept. of Medicine, Edmonton, Canada, 2St. Mary's Hospital, Dept. of Surgery and Cancer, London, United Kingdom, 3Hanover School of Medicine, Dept. of Urology, Hanover, Germany, 4Private Urologic Office, Practicioner, Frankfurt, Germany, 5University of Amsterdam, Dept. of Pharmacology and Pharmacotherapy, Amsterdam, Netherlands, The, 6Pfizer, Ltd, Sandwich, United Kingdom, 7Pfizer, Paris, France