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 ≥ 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.
Highlights
Drug treatments for overactive bladder (OAB) may fail because of non-adherence or discontinuation
Patients The study population consisted of men and women (‡ 18 years of age) with OAB symptoms [an average of ‡ 8 micturitions ⁄ 24 h and ‡ 1 urgency episode ⁄ 24 h, with or without urgency urinary incontinence (UUI) episodes] for at least 6 months prior to randomisation, and with a baseline score of ‡ 2 on the Patient Perception of Bladder Condition (PPBC) questionnaire at screening
The main reasons for discontinuation were Adverse events (AEs) (4.4%), withdrawal of consent (2.6%), protocol deviation (1.8%) and unsatisfactory therapeutic effect (1.8%), and were comparable between patients previously treated with oxybutynin ER or tolterodine ER except for the number of protocol deviations
Summary
Drug treatments for overactive bladder (OAB) may fail because of non-adherence or discontinuation. These issues are frequently observed in clinical practice and were exemplified in a recent evaluation of both the extended-release (ER) and immediaterelease formulations of the most commonly used antimuscarinic agents for OAB, oxybutynin and tolterodine, in a regional managed healthcare plan. The patient’s perception of effectiveness and tolerability may be a useful tool to predict whether patients stay on treatment or not. Darifenacin has been identified as having high in vitro selectivity for the M3 muscarinic receptor subtype thought to be responsible for detrusor contraction [2,3]. The efficacy, tolerability and safety of darifenacin in the treatment of OAB are wellestablished
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