Darifenacin treatment for overactive bladder in patients who expressed dissatisfaction with prior extended-release antimuscarinic therapy

N Zinner, K C Kobashi, U Ebinger, A Viegas, M Egermark, E Quebe-Fehling, P Koochaki, N Zinner, K C Kobashi, U Ebinger, A Viegas, M Egermark, E Quebe-Fehling, P Koochaki

Abstract

Introduction and objective: Patient perception of overactive bladder (OAB) treatment outcomes can be a useful indicator of benefit and may help drive persistence on treatment, which is known to be poor in OAB. It remains unclear whether OAB patients dissatisfied with one antimuscarinic can achieve satisfaction with another and supporting data are limited. This study investigated patient-reported outcomes and clinical parameters during darifenacin treatment in OAB patients who expressed dissatisfaction with prior extended-release (ER) oxybutynin or tolterodine therapy (administered for >or= 1 week within the past year).

Methods: This open-label study was conducted in darifenacin-naïve OAB patients. Patients received 7.5 mg darifenacin once daily with the possibility of up-titrating to 15 mg after 2 weeks, for up to 12 weeks. Efficacy parameters included the Patient's Perception of Bladder Condition (PPBC), patient satisfaction with treatment, micturition frequency and number of urgency and urge urinary incontinence (UUI) episodes. Adverse events (AEs) were also recorded.

Results: In total, 497 patients were treated (84.1% women). Darifenacin treatment resulted in statistically significant improvements in PPBC scores, micturition frequency, urgency and UUI episodes from baseline at 12 weeks. The improvements were similar for patients previously treated with oxybutynin ER or tolterodine ER. More than 85% of patients expressed satisfaction with darifenacin. As noted in other studies, the most common AEs were dry mouth and constipation, but these infrequently resulted in treatment discontinuation, which was low overall.

Conclusions: In this study, PPBC score and OAB symptoms were significantly improved, and satisfaction was high during treatment with darifenacin (7.5/15 mg) in patients who were dissatisfied with the previous antimuscarinic treatment.

Trial registration: ClinicalTrials.gov NCT00366002.

Figures

Figure 1
Figure 1
Study design overview. qd, once daily; PPBC, Patient Perception of Bladder Condition; PSTB, Patient Satisfaction with Treatment Benefits
Figure 2
Figure 2
Subject disposition and flow. ER, extended-release; ITT, intent-to-treat. *Three patients were included but did not receive treatment
Figure 3
Figure 3
Efficacy of darifenacin treatment on OAB symptoms in the intent-to-treat population (LOCF analysis), seen as: (A) daily micturition frequency, (B) daily urgency episodes and (C) weekly UUI episodes. ER, extended-release; UUI, urgency urinary incontinence
Figure 4
Figure 4
Different response levels for patients with ≥ 7 UUI episodes per week at baseline after 12 weeks of darifenacin treatment, according to previous treatment received. ER, extended-release; UUI, urgency urinary incontinence

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Source: PubMed

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