Patient-reported outcomes with the β3-adrenoceptor agonist mirabegron in a phase III trial in patients with overactive bladder.
To assess patient-reported outcomes (PROs) in patients with overactive bladder (OAB) receiving the novel β3-adrenoceptor agonist mirabegron.



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) 4 mg 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.



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.



At the approved dose of 50 mg/day, mirabegron significantly improves OAB patients' 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.
Urogynaecology Department, St Mary's Hospital, Imperial College, London, United Kingdom. vik.khullar@imperial.ac.uk.
Vik
V
Khullar
Department of Neuro-Urology, Sorbonne Universités, GREEN Group of Clinical Research in Neuro-Urology, Hôpital Tenon, Assistance Publique-Hôpitaux de Paris, Paris, France.
Gerard
G
Amarenco
Department of Urology, Hospital Universitario de Getafe, Universidad Europea de Madrid, Madrid, Spain.
Javier C
JC
Angulo
Astellas Pharma Global Development, Inc, Biostatistics, Northbrook, Illinois.
Mary Beth
MB
Blauwet
Astellas Pharma Europe Ltd, Chertsey, United Kingdom.
Jameel
J
Nazir
Astellas Pharma Europe Ltd, Chertsey, United Kingdom.
Isaac A
IA
Odeyemi
Astellas Pharma Global Development EU, Leiden, the Netherlands.
Zalmai
Z
Hakimi
D000041:Absenteeism; D000083:Acetanilides / Q000627:therapeutic use*; D058667:Adrenergic beta-3 Receptor Agonists / Q000627:therapeutic use*; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016496:Incontinence Pads / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000627:therapeutic use; D000071066:Patient Reported Outcome Measures; D011788:Quality of Life; D013844:Thiazoles / Q000627:therapeutic use*; D000068737:Tolterodine Tartrate / Q000627:therapeutic use; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000150:complications / Q000188:drug therapy* / Q000523:psychology
D000083:Acetanilides; D058667:Adrenergic beta-3 Receptor Agonists; D018727:Muscarinic Antagonists; D013844:Thiazoles; D000068737:Tolterodine Tartrate; C520025:mirabegron
overactive bladder (OAB); patient outcome assessment; quality of life; β3-adrenoceptor agonist