IMPROVEMENTS IN HEALTH-RELATED QUALITY OF LIFE WITH FESOTERODINE- KING'S HEALTH QUESTIONNAIRE ITEM ANALYSIS
Author(s)
Jeffrey Trocio, MPH, Manager, Outcomes Research1, Vik Khullar, MD, Urogynecologist2, Con Kelleher, MD, Consultant3, Pamela Ellsworth, MD, Consultant4, Diane Martire, MD, MPH, Medical Director1, Joseph Wang, T, MS11Pfizer Inc, New York, NY, USA; 2 St Mary's Hospital, London, United Kingdom; 3 St. Thomas' Hospital, London, United Kingdom; 4 Brown University, Cranston, RI, USA
Objective: Subjects with overactive bladder (OAB) have decreased health-related quality of life (HRQL). The positive effects of fesoterodine (FESO) and tolterodine extended release (TER) have been established in subjects with OAB using patient-reported outcomes. This analysis assessed the effects of FESO and TER on individual items of the King's Health Questionnaire (KHQ). Methods: This is a post hoc analysis of data from a multicenter, double-blind, placebo (PBO)–controlled trial. Eligible subjects with frequency and urgency or urgency urinary incontinence were randomized to PBO, FESO 4 mg, FESO 8 mg, or TER 4 mg for 12 weeks. Subjects completed the KHQ at baseline and end of treatment. The KHQ includes 9 domains with 21 items and a Symptom Severity scale; lower scores indicate better HRQL. Analysis of covariance was used to assess treatment-related effects on the 21 individual items of the 9 KHQ domains, with treatment and region as factors and baseline value as a covariate. Results: By the end of the study, FESO 8 mg significantly improved responses to 13 items vs. PBO; in comparison, FESO 4 mg and TER improved responses to 9 and 8 items, respectively (all P<0.01). There were no significant differences between treatment groups. Seven items did not improve with any treatment; most of these items were part of the Personal Relationships and General Health Perception domains. In general, items that improved the most with treatment had higher baseline values (ie, worse HRQL) compared with those that did not improve. Conclusion: Both doses of FESO (4 and 8 mg) significantly improved HRQL in subjects with OAB as evidenced by significantly better scores for 9 and 13 items of the KHQ vs PBO, respectively. The domains showing improvement were those for which improvement with OAB treatment would be expected.
Conference/Value in Health Info
2008-05, ISPOR 2008, Toronto, Ontario, Canada
Value in Health, Vol. 11, No. 3 (May/June 2008)
Code
PUK20
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Urinary/Kidney Disorders