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Neurourol Urodyn. 2016 Nov;35(8):987-994. doi: 10.1002/nau.22844. Epub 2015 Aug 19.

Patient-reported outcomes with the β3 -adrenoceptor agonist mirabegron in a phase III trial in patients with overactive bladder.

Author information

1
Urogynaecology Department, St Mary's Hospital, Imperial College, London, United Kingdom. vik.khullar@imperial.ac.uk.
2
Department of Neuro-Urology, Sorbonne Universités, GREEN Group of Clinical Research in Neuro-Urology, Hôpital Tenon, Assistance Publique-Hôpitaux de Paris, Paris, France.
3
Department of Urology, Hospital Universitario de Getafe, Universidad Europea de Madrid, Madrid, Spain.
4
Astellas Pharma Global Development, Inc, Biostatistics, Northbrook, Illinois.
5
Astellas Pharma Europe Ltd, Chertsey, United Kingdom.
6
Astellas Pharma Global Development EU, Leiden, the Netherlands.

Abstract

AIMS:

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

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) 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.

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 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.

KEYWORDS:

overactive bladder (OAB); patient outcome assessment; quality of life; β3-adrenoceptor agonist

PMID:
26288118
DOI:
10.1002/nau.22844
[Indexed for MEDLINE]
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