Long-term benefits of darifenacin treatment for patient quality of life: results from a 2-year extension study.
Author(s): Dwyer P, Kelleher C, Young J, Haab F, Lheritier K, Ariely R, Ebinger U
Affiliation(s): Urogynaecology Department, Mercy Hospital for Women, 163 Studley Road, Heidelberg, Victoria 3084, Australia. email@example.com
Publication date & source: 2008, Neurourol Urodyn., 27(6):540-7.
Publication type: Clinical Trial, Phase II; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
BACKGROUND AND AIMS: Overactive bladder (OAB), a chronic condition requiring long-term management, is associated with substantial impact on health-related quality of life (HRQoL). The short-term benefits of antimuscarinic drug treatment are well known. Here we investigate the impact on HRQoL of long-term treatment with the M(3)-selective muscarinic receptor antagonist darifenacin over 2 years. METHODS: HRQoL was assessed using the King's Health Questionnaire (KHQ) for patients with 'wet' OAB treated with darifenacin (7.5/15 mg once daily [o.d.]) in an open-label 2-year extension of two double-blind feeder studies. Data were also analyzed for the subset of patients who continued darifenacin 7.5/15 mg o.d. directly into the extension study from the feeder studies (the 'darifenacin continuation' group), and also older patients (>or=65 years) and men within this group. RESULTS: The total study population comprised 716 patients, of whom 303 patients formed the 'darifenacin continuation' group (including 85 patients >or=65 years and 41 men). Substantial impairment of HRQoL was noted in baseline KHQ assessments. KHQ scores improved significantly from feeder-study baseline to extension study end/last visit in eight of the nine domains, with more than 50% of patients reporting improvements in seven of the nine domains. Despite fewer patients, significant improvements in KHQ scores were also observed in the subsets of older patients (>or=65 years) and men. Almost two-thirds of the 'darifenacin continuation' group were either satisfied or extremely satisfied with treatment. CONCLUSIONS: Long-term darifenacin treatment was associated with significant and clinically meaningful improvements in HRQoL for patients with 'wet' OAB over 2 years. (c) 2008 Wiley-Liss, Inc.