Introduction and Objectives
The Patient’s Perception of Bladder Condition (PPBC) is a validated measure of a global assessment of treatment benefits (Coyne et al. Eur Urol 2006).
We evaluated the efficacy of darifenacin (DAR) in improving perceptions of their bladder condition in pts dissatisfied with prior extended-release (ER) oxybutynin (OXY) or tolterodine (TOL) treatment.
Methods
This was an open-label study of 12 wks of once-daily DAR treatment in DAR-naïve adults (≥18yrs) with OAB symptoms for ≥6mths, dissatisfied with prior OXY-ER or TOL-ER treatment (received for ≥1wk within 12mths). Following a 2-wk screening and 1-wk baseline (BL), pts received DAR 7.5mg for 2wks, then were offered up-titration to 15mg with stable dose thereafter. The primary endpoint was the improvement in score from BL to 12wks (or last visit) in PPBC. Numbers of voids/d, urgency episodes/d and urge urinary incontinence (UUI) episodes/wk were determined from bladder diaries.
Results
500 patients enrolled, 497 were treated (mean age 60.9yrs, 84.1% women) and 437 completed the study. DAR resulted in significant improvements in PPBC scores, regardless of previous antimuscarinic treatment (Table). Changes in PPBC scores from BL to study end (from median 4.0 to 3.0; mean 4.5 to 3.1) correspond with a change in PPBC responses from “my bladder causes me some moderate/severe problems” to “my bladder causes me some minor problems”. Results were similar in pts previously treated with OXY ER and TOL ER. Significant improvements from BL to study end were also seen in daily micturition frequency, daily urgency episodes and weekly UUI episodes (median [%] reductions 2.0 [19.5], 2.8 [61.6] and 11.4 [85.7], respectively, for the total patient population), again with similar improvements for pts previously treated with OXY-ER or TOL-ER.
Table 1: Influence of DAR on PPBC in pts dissatisfied with prior treatment (*p<0.0001 for change from baseline [Wilcoxon signed-rank test]). The most common AEs were dry mouth (20.1%) and constipation (14.1%), infrequently leading to discontinuation (1.6% and 0.8%, respectively).
Conclusions
This study demonstrated that OAB pts who have had an unsatisfactory experience with OXY or TOL ER therapy for their OAB may benefit from DAR (7.5/15mg once daily) treatment.
Keywords
Antimuscarinic, darifenacin, overactive bladder, patient-reported outcomes