• Open Access

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

Authors


  • Disclosures
    Norman Zinner has acted as a consultant and/or speaker or conducted research for Allergan, Astellas, Eli Lilly, Esprit, GlaxoSmithKline, Indevus, Novartis, Pfizer and Watson. Kathleen C. Kobashi has acted as a consultant and/or speaker or conducted research for Novartis, Astellas and Coloplast. Ursula Ebinger and Andrea Viegas are employees of, and own shares in, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Mathias Egermark and Erhard Quebe-Fehling are employees of, and own shares in, Novartis Pharma AG, Basel, Switzerland. Pat Koochaki is an employee of Procter and Gamble Pharmaceuticals Corporation, Cincinnati, OH, USA.

  • Study registered at:
    http://www.clinicaltrials.gov (reference NCT00366002).

  • Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation.

Dr N. Zinner,
Western Clinical Research, 23441 Madison Street, Suite 140, Torrance, CA 90505, USA
Tel.: + 1 310 373 9452
Fax: + 1 310 378 0342
Email: wewedoc@aol.com

Summary

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.

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