Long-term benefits of darifenacin treatment for patient quality of life: results from a 2-year extension study.
OBJECTIVE
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.
Dwyer
Peter
P
Urogynaecology Department, Mercy Hospital for Women, 163 Studley Road, Heidelberg, Victoria 3084, Australia. pdwyer@connexus.net.au
Kelleher
Con
C
Young
Jay
J
Haab
François
F
Lheritier
Karine
K
Ariely
Rinat
R
Ebinger
Ursula
U
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001315:Australia; D001572:Benzofurans / Q000627:therapeutic use*; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000627:therapeutic use*; D017060:Patient Satisfaction; D011759:Pyrrolidines / Q000627:therapeutic use*; D011788:Quality of Life; D043587:Receptor, Muscarinic M3 / Q000037:antagonists & inhibitors*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*
D001572:Benzofurans; D018727:Muscarinic Antagonists; D011759:Pyrrolidines; D043587:Receptor, Muscarinic M3; C101207:darifenacin