Patient-Reported Outcomes With the b3-Adrenoceptor Agonist Mirabegron in a Phase III Trial in Patients With Overactive Bladder
Methods: Data from a randomised, double-blind, controlled phase III trial in 1,987 patients aged !18 years with OAB symptoms for !3 months were analysed. Patients received placebo, mirabegron 50 or 100 mg/day, or tolterodine extended release (ER) 4mg orally once daily for 12 weeks after a 2-week placebo run-in. Prespecified analysis of PROs (changes in OAB Questionnaire [OAB-q], Patient Perception of Bladder Condition [PPBC],
and Work Productivity and Activity Impairment: Specific Health Problem [WPAI-SHP] instrument) in patients treated with mirabegron 50 mg/day, tolterodine ER 4 mg/day or placebo is reported. Post-hoc analyses of OAB-q, PPBC and the Treatment Satisfaction-Visual Analogue Scale (TS-VAS) in patients who were incontinent at baseline are also reported.
Results: Significant improvements over placebo in OAB-q coping and concern from baseline to final visit were observed with mirabegron 50 mg/day. No significant improvements in these parameters were observed with tolterodine ER 4 mg/ day. Mirabegron 50 mg/day significantly increased the proportion of patients showing a PPBC improvement over placebo. Mirabegron 50 mg/day also produced greater improvements in WPAI-SHP presenteeism and greater reductions in absenteeism and overall work impairment than placebo or tolterodine ER 4 mg/day. The impact of mirabegron 50 mg/day treatment on PROs in the incontinent population appears to be greater than that in the overall OAB population.
Conclusions: At the approved dose of 50 mg/day, mirabegron significantly improvesOABpatients’ perception of disease and quality of life, independent of whether they are incontinent at baseline. Neurourol. Urodynam. 35:987–994, 2016.
# 2015 The Authors. Neurourology and Urodynamics published by Wiley Periodicals, Inc.
Authors: Vik Khullar, Gerard Amarenco, Javier C. Angulo, Mary Beth Blauwet, Jameel Nazir, Isaac A. Odeyemi, and Zalmai Hakimi
Urogynaecology Department, St Mary’s Hospital, Imperial College, London, United Kingdom
Department of Neuro-Urology, Sorbonne Universit!es, GREEN Group of Clinical Research in Neuro-Urology, H^opital Tenon,
Assistance Publique-H^opitaux de Paris, Paris, France
Department of Urology, Hospital Universitario de Getafe, Universidad Europea de Madrid, Madrid, Spain
Astellas Pharma Global Development, Inc, Biostatistics, Northbrook, Illinois
Astellas Pharma Europe Ltd, Chertsey, United Kingdom
Astellas Pharma Global Development EU, Leiden, the Netherlands