{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,27]],"date-time":"2025-11-27T02:55:07Z","timestamp":1764212107541,"version":"3.37.3"},"reference-count":36,"publisher":"The Endocrine Society","issue":"11","license":[{"start":{"date-parts":[[2019,6,5]],"date-time":"2019-06-05T00:00:00Z","timestamp":1559692800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009857","name":"Regeneron Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009857","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,11,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Context<\/jats:title>\n                  <jats:p>In the ODYSSEY CHOICE I trial, alirocumab 300 mg every 4 weeks (Q4W) was assessed in patients with hypercholesterolemia. Alirocumab efficacy and safety were evaluated in a patient subgroup with type 2 diabetes mellitus (T2DM) and who were receiving maximally tolerated statins with or without other lipid-lowering therapies.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Participants received either alirocumab 300 mg Q4W (n = 458, including 96 with T2DM) or placebo (n = 230, including 50 with T2DM) for 48 weeks, with alirocumab dose adjustment to 150 mg every 2 weeks at Week (W) 12 if W8 low-density lipoprotein cholesterol (LDL-C) levels were \u226570 mg\/dL or \u2265 100 mg\/dL, depending on cardiovascular risk, or if LDL-C reduction was &lt;30% from baseline. Efficacy end points included percentage change from baseline to W24 for lipids, and time-averaged LDL-C over W21 to W24.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In individuals with T2DM, LDL-C reductions from baseline to W24 and the average of W21 to W24 were significantly greater with alirocumab (\u221261.6% and \u221268.8%, respectively) vs placebo. At W24, alirocumab significantly reduced levels of non\u2013high-density lipoprotein cholesterol (HDL-C) and other lipids. At W24, 85.9% and 12.5% of individuals in the alirocumab and placebo groups, respectively, reached both non\u2013HDL-C &lt;100 mg\/dL and LDL-C &lt;70 mg\/dL. At W12, In total, 18% of alirocumab-treated participants received dose adjustment. The most common treatment-emergent adverse events were upper respiratory tract infection and injection-site reaction. No clinically significant changes in fasting plasma glucose and glycated hemoglobin were observed.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>In individuals with T2DM, alirocumab 300 mg Q4W was generally well tolerated and efficacious in reducing atherogenic lipoproteins.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1210\/jc.2018-02703","type":"journal-article","created":{"date-parts":[[2019,6,5]],"date-time":"2019-06-05T09:05:23Z","timestamp":1559725523000},"page":"5253-5262","source":"Crossref","is-referenced-by-count":6,"title":["Efficacy and Safety of Alirocumab 300 mg Every 4 Weeks in Individuals With Type 2 Diabetes on Maximally Tolerated Statin"],"prefix":"10.1210","volume":"104","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8807-6442","authenticated-orcid":false,"given":"Dirk","family":"M\u00fcller-Wieland","sequence":"first","affiliation":[{"name":"Department of Medicine I, University Hospital, RWTH Aachen University, Aachen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel J","family":"Rader","sequence":"additional","affiliation":[{"name":"Department of Medicine and Genetics, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennysylvania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patrick M","family":"Moriarty","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Division of Clinical Pharmacology, University of Kansas Medical Center, Kansas City, Kansas"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean","family":"Bergeron","sequence":"additional","affiliation":[{"name":"Clinique des Maladies Lipidiques, Department of Medicine, Centre Hospitalier Universitaire de Qu\u00e9bec \u2013 Universit\u00e9 Laval, Qu\u00e9bec, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gisle","family":"Langslet","sequence":"additional","affiliation":[{"name":"Lipid Clinic, Oslo University Hospital, Oslo, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kausik K","family":"Ray","sequence":"additional","affiliation":[{"name":"Imperial Centre for Cardiovascular Disease Prevention, Imperial College London, London, United Kingdom"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Garen","family":"Manvelian","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc., Tarrytown, New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Desmond","family":"Thompson","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc., Tarrytown, New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maja","family":"Bujas-Bobanovic","sequence":"additional","affiliation":[{"name":"Sanofi, Paris, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eli M","family":"Roth","sequence":"additional","affiliation":[{"name":"The Sterling Research Group and University of Cincinnati, Cincinnati, Ohio"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"80","published-online":{"date-parts":[[2019,6,5]]},"reference":[{"key":"2019092615514299100_bib1","doi-asserted-by":"crossref","first-page":"S1","DOI":"10.1016\/j.jacl.2015.09.002","article-title":"National Lipid Association recommendations for patient-centered management of dyslipidemia: part 2. 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