{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T22:23:30Z","timestamp":1790807010631,"version":"4.1.0"},"reference-count":47,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2019,4,14]],"date-time":"2019-04-14T00:00:00Z","timestamp":1555200000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2019,6]]},"abstract":"<jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>The aim of this study was to evaluate the efficacy and safety of evolocumab with background atorvastatin in Chinese patients with type 2 diabetes mellitus (T2DM) and hyperlipidaemia or mixed dyslipidaemia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and methods<\/jats:title>\n                    <jats:p>\n                      This is a pre\u2010specified analysis of patients in the BERSON study (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      , NCT02662569) in China. Patients initiated background atorvastatin 20\u2009mg\/d, after which they were randomized 2:2:1:1 to evolocumab 140\u2009mg every 2\u2009weeks (Q2W) or 420\u2009mg monthly (QM) or to placebo Q2W or QM. Co\u2010primary endpoints were percentage change in LDL cholesterol (LDL\u2010C) from baseline to week 12 and from baseline to the mean of weeks 10 and 12. Additional endpoints included atherogenic lipids, glycaemic measures and adverse events (AEs).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among 453 patients randomized in China, 451 received at least one dose of study drug (evolocumab or placebo). Evolocumab significantly reduced LDL\u2010C compared with placebo at week 12 (Q2W, \u221285.0%; QM, \u221274.8%) and at the mean of weeks 10 and 12 (Q2W, \u221280.4%; QM, \u221281.0%) (adjusted\n                      <jats:italic>P<\/jats:italic>\n                      &lt;\u20090.0001 for all) when administered with background atorvastatin. Non\u2010HDL\u2010C, ApoB100, total cholesterol, Lp(a), triglycerides, HDL\u2010C and VLDL\u2010C significantly improved with evolocumab vs placebo. No new safety findings were observed with evolocumab. The incidence of diabetes AEs was higher with evolocumab compared with placebo. There were no differences over time between evolocumab and placebo in measures of glycaemic control.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In patients in China with T2DM and hyperlipidaemia or mixed dyslipidaemia receiving background atorvastatin, evolocumab significantly reduced LDL\u2010C and other atherogenic lipids, was well tolerated, and had no notable impact on glycaemic measures.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.13700","type":"journal-article","created":{"date-parts":[[2019,3,9]],"date-time":"2019-03-09T07:58:22Z","timestamp":1552118302000},"page":"1464-1473","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":30,"title":["Randomized study of evolocumab in patients with type 2 diabetes and dyslipidaemia on background statin: Pre\u2010specified analysis of the Chinese population from the BERSON clinical trial"],"prefix":"10.1111","volume":"21","author":[{"given":"Yundai","family":"Chen","sequence":"first","affiliation":[{"name":"Department of Cardiology Chinese People's Liberation Army General Hospital  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zuyi","family":"Yuan","sequence":"additional","affiliation":[{"name":"First Affiliated Hospital of Xi'an Jiaotong University  Shaanxi China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juming","family":"Lu","sequence":"additional","affiliation":[{"name":"Department of Endocrinology Chinese People's Liberation Army General Hospital  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Freddy G.","family":"Eliaschewitz","sequence":"additional","affiliation":[{"name":"CPCLIN\/DASA \u2010 Centro de Pesquisas Cl\u00ednicas  S\u00e3o Paulo Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4180-2010","authenticated-orcid":false,"given":"Alberto J.","family":"Lorenzatti","sequence":"additional","affiliation":[{"name":"Clinical Research and Cardiology, Instituto Medico DAMIC \/ Fundaci\u00f3n Rusculleda  C\u00f3rdoba Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Laura","family":"Monsalvo","sequence":"additional","affiliation":[{"name":"Clinical Development, Amgen Inc.  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