caa a22 4500 606178570 CHVBK 20210128100757.0 cr unu---uuuuu 210128e20150701xx s 000 0 eng 10.1007/s11136-014-0904-4 doi (NATIONALLICENCE)springer-10.1007/s11136-014-0904-4 The effect of mirabegron on patient-related outcomes in patients with overactive bladder: the results of post hoc correlation and responder analyses using pooled data from three randomized Phase III trials [Elektronische Daten] [D. Castro-Diaz, C. Chapple, Z. Hakimi, M. Blauwet, L. Delgado-Herrera, W. Lau, S. Mujais] Purpose: To understand how improvements in the symptoms of overactive bladder (OAB) seen with the β3-adrenoceptor agonist mirabegron 50mg, correlate with patient experience as measured by validated and standard patient-reported outcomes (PROs), and to identify whether there is overall directional consistency in the responsiveness of PROs to treatment effect. Methods: In a post hoc analysis of pooled data from three randomized, double-blind, placebo-controlled, 12-week Phase III trials of mirabegron 50 mg once daily, responder rates for incontinence frequency (≥50% reduction in incontinence episodes/24 h from baseline to final visit), micturition frequency (≤8 micturitions/24 h at final visit), and PROs [minimally important differences in patient perception of bladder condition (PPBC) and subsets of the overactive bladder questionnaire (OAB-q) measuring total health-related quality of life (HRQoL), and symptom bother] were evaluated individually and in combination. Results: Mirabegron 50mg demonstrated greater improvement from baseline to final visit than placebo for each of the responder analyses, whether for individual objective and subjective outcomes or combinations thereof. These improvements versus placebo were statistically significant for all double and triple responder analyses and for all single responder analyses except PPBC. PRO measurements showed directional consistency and significant correlations, and there were also significant correlations between objective and subjective measures of efficacy. Conclusions: The improvements in objective measures seen with mirabegron 50mg translate into a meaningful clinical benefit as evident by the directional consistency seen in HRQoL measures of benefit. The Author(s), 2015 Mirabegron nationallicence Overactive bladder nationallicence Patient-reported outcomes nationallicence Quality of life nationallicence Correlation nationallicence Castro-Diaz D. Department of Urology, University Hospital of the Canary Islands, Ofra s/n. La Cuesta-38320-La Laguna, Santa Cruz de Tenerife, Spain aut Chapple C. Department of Urology, Royal Hallamshire Hospital, Sheffield, UK aut Hakimi Z. Astellas Pharma Global Development, Leiden, The Netherlands aut Blauwet M. Astellas Pharma Global Development, Northbrook, IL, USA aut Delgado-Herrera L. Astellas Pharma Global Development, Northbrook, IL, USA aut Lau W. Astellas Pharma Global Development, Northbrook, IL, USA aut Mujais S. Astellas Pharma Global Development, Northbrook, IL, USA aut Quality of Life Research Springer International Publishing 24/7(2015-07-01), 1719-1727 0962-9343 24:7<1719 2015 24 11136 https://doi.org/10.1007/s11136-014-0904-4 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s11136-014-0904-4 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Castro-Diaz D. Department of Urology, University Hospital of the Canary Islands, Ofra s/n. La Cuesta-38320-La Laguna, Santa Cruz de Tenerife, Spain aut NATIONALLICENCE 700 1- Chapple C. Department of Urology, Royal Hallamshire Hospital, Sheffield, UK aut NATIONALLICENCE 700 1- Hakimi Z. Astellas Pharma Global Development, Leiden, The Netherlands aut NATIONALLICENCE 700 1- Blauwet M. Astellas Pharma Global Development, Northbrook, IL, USA aut NATIONALLICENCE 700 1- Delgado-Herrera L. Astellas Pharma Global Development, Northbrook, IL, USA aut NATIONALLICENCE 700 1- Lau W. Astellas Pharma Global Development, Northbrook, IL, USA aut NATIONALLICENCE 700 1- Mujais S. Astellas Pharma Global Development, Northbrook, IL, USA aut NATIONALLICENCE 773 0- Quality of Life Research Springer International Publishing 24/7(2015-07-01), 1719-1727 0962-9343 24:7<1719 2015 24 11136