{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T11:28:41Z","timestamp":1790162921538,"version":"4.1.0"},"reference-count":37,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2018,3,23]],"date-time":"2018-03-23T00:00:00Z","timestamp":1521763200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Sanofi and Regeneron Pharmaceuticals, Inc"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2018,6]]},"abstract":"<jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To compare alirocumab, a proprotein convertase subtilisin\u2010kexin type 9 inhibitor, with usual care (UC) in individuals with type 2 diabetes (T2DM) and mixed dyslipidaemia not optimally managed by maximally tolerated statins in the ODYSSEY DM\u2010DYSLIPIDEMIA trial (NCT02642159).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>The UC options (no additional lipid\u2010lowering therapy; fenofibrate; ezetimibe; omega\u20103 fatty acid; nicotinic acid) were selected prior to stratified randomization to open\u2010label alirocumab 75\u2009mg every 2\u2009weeks (with increase to 150\u2009mg every 2\u2009weeks at week 12 if week 8 non\u2010HDL cholesterol concentration was \u22652.59\u2009mmol\/L [100\u2009mg\/dL]) or UC for 24\u2009weeks. The primary efficacy endpoint was percentage change in non\u2010HDL cholesterol from baseline to week 24.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The randomized population comprised 413 individuals (intention\u2010to\u2010treat population,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009409; safety population,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009412). At week 24, the mean non\u2010HDL cholesterol reductions were superior with alirocumab (\u221232.5% difference vs UC, 97.5% confidence interval \u221238.1 to \u221227.0;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u2009.0001). Overall, 63.6% of alirocumab\u2010treated individuals were maintained on 75\u2009mg every 2\u2009weeks. Alirocumab also reduced LDL cholesterol (\u221243.0%), apolipoprotein B (\u221232.3%), total cholesterol (\u221224.6%) and LDL particle number (\u221237.8%) at week 24 vs UC (all\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u2009.0001). Consistent with the overall trial comparison, alirocumab reduced non\u2010HDL cholesterol to a greater degree within each UC stratum at week 24. The incidence of treatment\u2010emergent adverse events was 68.4% (alirocumab) and 66.4% (UC). No clinically meaningful effect on glycated haemoglobin, or change in number of glucose\u2010lowering agents, was seen.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In individuals with T2DM and mixed dyslipidaemia on maximally tolerated statin, alirocumab showed superiority to UC in non\u2010HDL cholesterol reduction and was generally well tolerated.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.13257","type":"journal-article","created":{"date-parts":[[2018,2,13]],"date-time":"2018-02-13T06:42:44Z","timestamp":1518504164000},"page":"1479-1489","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":93,"title":["Alirocumab vs usual lipid\u2010lowering care as add\u2010on to statin therapy in individuals with type 2 diabetes and mixed dyslipidaemia: The ODYSSEY DM\u2010DYSLIPIDEMIA randomized trial"],"prefix":"10.1111","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7166-060X","authenticated-orcid":false,"given":"Kausik K.","family":"Ray","sequence":"first","affiliation":[{"name":"Department of Primary Care and Public Health, Imperial Centre for Cardiovascular Disease Prevention Imperial College  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1040-6229","authenticated-orcid":false,"given":"Lawrence A.","family":"Leiter","sequence":"additional","affiliation":[{"name":"Li Ka Shing Knowledge Institute, St. Michael's Hospital University of Toronto  Toronto Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dirk","family":"M\u00fcller\u2010Wieland","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine I University Hospital Aachen  Aachen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bertrand","family":"Cariou","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, l'institut du thorax, CHU Nantes, Nantes, INSERM, CNRS UNIV Nantes  Nantes France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helen M.","family":"Colhoun","sequence":"additional","affiliation":[{"name":"University of Edinburgh  Edinburgh UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4821-0117","authenticated-orcid":false,"given":"Robert R.","family":"Henry","sequence":"additional","affiliation":[{"name":"University of California San Diego School of Medicine and Center for Metabolic Research, Veterans Affairs, San Diego Healthcare System  San Diego California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francisco J.","family":"Tinahones","sequence":"additional","affiliation":[{"name":"Department of Clinical Endocrinology and Nutrition (IBIMA), Hospital Virgen de la Victoria University of M\u00e1laga, CIBER Fisiopatolog\u00eda de la Obesidad y Nutrici\u00f3n (CIBERobn), Instituto de Salud Carlos III  M\u00e1laga Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maja","family":"Bujas\u2010Bobanovic","sequence":"additional","affiliation":[{"name":"Sanofi  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Domenger","sequence":"additional","affiliation":[{"name":"Sanofi  Gentilly France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexia","family":"Letierce","sequence":"additional","affiliation":[{"name":"Biostatistics and Programming Department Sanofi  Chilly\u2010Mazarin France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita","family":"Samuel","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc.  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