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Assessing Preference-Based Outcome Measures for Overactive Bladder: An Evaluation of Patient-Reported Outcome Data from the BESIDE Clinical Trial

Mike Herdman (), Jameel Nazir, Zalmai Hakimi, Emad Siddiqui, Moses Huang, Marco Pavesi, Scott MacDiarmid, Marcus J. Drake and Nancy Devlin ()
Additional contact information
Mike Herdman: The Office of Health Economics
Jameel Nazir: Astellas Pharma Europe Ltd., Astellas Medical Affairs, EMEA, HEOR
Zalmai Hakimi: Astellas Pharma Europe B.V., Astellas Medical Affairs, Global, HEOR
Emad Siddiqui: Astellas Pharma Europe Ltd., Astellas Medical Affairs, EMEA, HEOR
Moses Huang: Astellas Pharma Europe Ltd., Astellas Medical Affairs, EMEA, HEOR
Marco Pavesi: European Foundation for the study of Chronic LIver Failure (EF-CLIF)
Scott MacDiarmid: Alliance Urology Specialists
Marcus J. Drake: University of Bristol and Bristol Urological Institute

The Patient: Patient-Centered Outcomes Research, 2017, vol. 10, issue 6, 677-686

Abstract: Abstract Objectives The aim of this study was to compare outcomes using two preference-based measures of health status (EQ-5D-5L and OAB-5D) in patients with overactive bladder (OAB) treated with solifenacin plus mirabegron or solifenacin monotherapy in the BESIDE trial. Methods Patients with OAB who remained incontinent after 4 weeks’ treatment with solifenacin 5 mg were randomized 1:1:1 to combination treatment (solifenacin 5 mg plus mirabegron [25 mg for the first 4 weeks/50 mg for the last 8 weeks]), solifenacin 5 mg, or solifenacin 10 mg. EQ-5D-5L and OAB-q were administered at baseline, weeks 4, 8, 12, and end of treatment (EoT). OAB-5D scores were derived from OAB-q results. Responder analysis was carried out using several definitions of minimally important difference. Results A total of 2054 patients received one or more doses of study treatment (combination, n = 694; solifenacin 5 mg, n = 684; solifenacin 10 mg, n = 676). EQ-5D-5L Index mean score changes (from baseline to EoT) were greater with combination (0.059) than with solifenacin 5 mg (0.040) and 10 mg (0.044) monotherapy, but the differences were not statistically significant. A significantly greater improvement was observed for combination on OAB-5D (0.107 vs 0.085 for 5 mg, and 0.087 for 10 mg; p ≤ 0.01). The dimensions most improved overall were anxiety/depression, pain/discomfort, and usual activities on EQ-5D-5L, and urge, urine loss, and coping on OAB-5D. The proportion of responders was significantly greater with combination compared with monotherapy using OAB-5D only. Conclusions Improvements were observed in all study arms on both the EQ-5D-5L and OAB-5D, although only the OAB-5D showed a statistically significant benefit for combination versus solifenacin monotherapy. Combining generic and condition-specific preference-based health status measures allowed for assessment of dimensions that were particularly relevant to this patient population, while permitting comparison with outcomes from other studies, treatments, and populations via EQ-5D.

Date: 2017
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