{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T06:06:45Z","timestamp":1791526005054,"version":"4.3.4"},"reference-count":34,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2019,9,30]],"date-time":"2019-09-30T00:00:00Z","timestamp":1569801600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100007705","name":"Astellas Pharma Global Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007705","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["LUTS"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>This analysis was conducted to investigate the cardiovascular (CV) safety outcomes from the MILAI II study. MILAI II was conducted to evaluate the long\u2010term safety and efficacy of antimuscarinic add\u2010on therapy to mirabegron over 52\u2009weeks in patients with overactive bladder (OAB) symptoms.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>MILAI II consisted of a 2\u2010week screening period (patients received mirabegron 50\u2009mg once daily) plus a 52\u2010week treatment period (patients were randomized to receive a combination of mirabegron 50\u2009mg\/d plus solifenacin 5 mg\/d, propiverine 20\u2009mg\/d, imidafenacin 0.2 mg\/d, or tolterodine 4 mg\/d). CV safety was assessed using treatment\u2010emergent adverse events (TEAEs), vital signs, and 12\u2010lead electrocardiograms (ECGs). Vital signs and ECG data were evaluated for each patient using worst post\u2010baseline values reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 647 patients, 570 (88.1%) were female with a mean age of 65\u2009years. CV history at baseline and CV\u2010related concomitant medication use throughout the study were balanced between groups. The incidences of overall and drug\u2010related CV TEAEs were \u22648.1% and \u22646.2%, respectively, for all groups. The most common TEAEs were ECG T wave amplitude decreased, ECG QT prolonged, and ventricular extrasystoles. Overall, 36 TEAEs of interest related to the CV system that were possibly\/probably related to treatment were reported with similar incidences for each group. For the worst post\u2010baseline vital signs and ECGs, no relationships were noted in terms of either timing or treatment group.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>A favorable CV safety profile was observed following long\u2010term combination treatment with mirabegron and an antimuscarinic in patients with OAB symptoms.<\/jats:p><\/jats:sec>","DOI":"10.1111\/luts.12286","type":"journal-article","created":{"date-parts":[[2019,10,1]],"date-time":"2019-10-01T05:47:19Z","timestamp":1569908839000},"page":"68-80","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Cardiovascular safety of antimuscarinic add\u2010on therapy in patients with overactive bladder who had a suboptimal response to mirabegron monotherapy: A post hoc analysis from the Japanese MILAI II study"],"prefix":"10.1111","volume":"12","author":[{"given":"Takao","family":"Katoh","sequence":"first","affiliation":[{"name":"Cardiovascular Center, Mita Hospital International University of Health and Welfare  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuhiko","family":"Igawa","sequence":"additional","affiliation":[{"name":"Department of Continence Medicine The University of Tokyo Graduate School of Medicine  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Osamu","family":"Yamaguchi","sequence":"additional","affiliation":[{"name":"Department of Chemical Biology and Applied Chemistry Nihon University School of Engineering  Koriyama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daisuke","family":"Kato","sequence":"additional","affiliation":[{"name":"Astellas Pharma Inc.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takuya","family":"Hamada","sequence":"additional","affiliation":[{"name":"Astellas Pharma Inc.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kentaro","family":"Kuroishi","sequence":"additional","affiliation":[{"name":"Astellas Pharma Inc.  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