Impact of solifenacin on quality of life, medical care use, work productivity, and health utility in the elderly: an exploratory subgroup analysis.
BACKGROUND
Overactive bladder (OAB) is a common problem among the elderly and a financial burden to society. The prevalence of OAB increases with age and affects > or = 25% of people aged > or = 65 years.


OBJECTIVE
The goal of this exploratory subgroup analysis of the VESIcare Efficacy and Research Study US (VERSUS) was to assess changes in health-related quality of life (HRQoL), medical care resource utilization, work and activity impairment, and health utility among elderly patients with OAB who continued to have urgency symptoms with tolterodine and were willing to try solifenacin.


METHODS
This was a 12-week, multicenter, prospective, open-label, noncomparative, flexible-dosing study designed to assess the efficacy and tolerability of solifenacin. Patients who received tolterodine 4 mg/d for > or = 4 weeks but continued to experience urgency symptoms (> or = 3 urgency episodes/24 hours) were enrolled. This exploratory analysis describes results from 2 elderly cohorts (patients 65 to 74 years and > or = 75 years of age). After a washout period of > or = 14 days, patients began treatment with solifenacin 5 mg/d with dosing adjustments allowed at week 4 (to 10 mg/d) and at week 8 (back to 5 mg/d for patients whose dose was increased to 10 mg/d at week 4). Outcomes were assessed using the OAB-q (a questionnaire specific to OAB and HRQoL), the Work Productivity and Activity Impairment-Specific Health Problem index, the Medical Care Use Index, and the Health Utilities Index Mark 2 and Mark 3 (HUI2/3), administered at the prewashout and week-12 visits.


RESULTS
The subgroup analysis included 108 patients 65 to 74 years of age and 86 patients > or = 75 years of age. Patients in both age groups experienced significant improvement in HRQoL (P < 0.001), as well as significant reductions in nonprotocol-related office visits (P < 0.001) and activity impairment (P < 0.025). A significant reduction in the use of pads/diapers was reported for patients 65 to 74 years of age (P < 0.018), and patients in this age group who were working reported significantly less impairment related to OAB while working during solifenacin treatment than during tolterodine treatment (P < 0.042). No significant differences in HUI2/3 scores were observed in either of the elderly subgroups.


CONCLUSIONS
Overall, solifenacin was found to improve symptom bother, HRQoL, work productivity, activity participation, and reduced medical care resource utilization in these elderly subjects with OAB who continued to have urgency symptoms with tolterodine and were willing to try solifenacin. This was an exploratory subgroup analysis of an open-label, noncomparative study; further research is needed to confirm these results.
Zinner
Norman
N
Western Clinical Research, Inc., Torrance, California 90505, USA. wewedoc@aol.com
Noe
Les
L
Rasouliyan
Lawrence
L
Marshall
Thomas
T
Runken
M Christopher
MC
Seifeldin
Raafat
R
D000368:Aged; D004526:Efficiency / Q000187:drug effects*; D005260:Female; D006295:Health Resources / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D011812:Quinuclidines / Q000009:adverse effects / Q000627:therapeutic use*; D000069464:Solifenacin Succinate; D044005:Tetrahydroisoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D053201:Urinary Bladder, Overactive / Q000188:drug therapy* / Q000523:psychology
D011812:Quinuclidines; D044005:Tetrahydroisoquinolines; D000069464:Solifenacin Succinate