Patient-Reported Outcomes with the B3-Adrenoceptor Agonist Mirabegron in Phase III Trial in Patients with Overactive Bladder - Commentary
Data was collected from the original multicentre, randomized, double-blind, parallel-group, placebo- and active-controlled phase III trial, SCORPIO3. The inclusion criteria were patients older than 18, and symptoms of OAB greater than 3 months. Patients who met enrollment criteria were then randomized to either oral placebo, mirabegron 50mg or 100mg/day, or tolterodine ER 4mg one daily for 12 weeks. The three PRO’s used in the study were: Treatment Satisfaction-Visual Analogue Scale (TS-VAS), Symptom Bother on the OAB Questionnaire (OAB-q), and Patient Perception of Bladder Condition (PPBC). Prespecified analysis and post-hoc analysis of changes in TS-VAS, OAB-q scores, and PPBC with mirabegron 50mg/day, tolterodine ER 4mg/day, and placebo were reported. Work productivity and activity impairment: specific health problem (WPAI-SHIP) instrument and incontinence pad use were also used to assess the effect of therapy on work productivity.
Out of the original 1,987 patients in the clinical trial, 1428 patients were included in the analysis of this study. The results of the study revealed significant improvements over placebo in OAB-q coping, concern and HRQoL total score were observed with mirabegron 50 mg/day. The PPBC analysis showed more patients significantly improved with both mirabegron 50mg/day and tolterodien ER 4mg/day relative to placebo, but no statistically significant major improvements. Mirabegron 50 mg/day produced higher reductions in absenteeism and overall work impairment, and improved presenteeism than in both placebo and tolderodine. Some limitations of the study included limited 12-week timeframe, and study was not powered for a head-to-head comparison of mirabegron and tolterodine.
In conclusion, 12 weeks of therapy with mirabegron at 50mg/day produces significant improvements in OAB-q and PPBC compared to placebo, and associated with numerical improvements in WPAI-SHIP scores and reduction in incontinence pad use at 4 weeks. These findings correlate with higher patient-reported perceptions and quality of life, whether or not they are incontinence baseline. Patients with OAB are expected to have greater benefit with mirabegron therapy compared to other treatments.
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Authors: Vik Khullar, Gerard Amarenco, Javier C. Angulo, Mary Beth Blauwet, Jameel Nazir, Isaac A. Odeyemi, and Zalmai Hakimi
Affiliations: Urogynaecology Department, St Mary’s Hospital, Imperial College, London, United Kingdom, Department of Neuro-Urology, Sorbonne Universites, GREEN Group of Clinical Research in Neuro-Urology, Hopital Tenon, Assistance Publique-Hopitaux 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
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