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J Clin Endocrinol Metab. 2019 Nov 1;104(11):5253-5262. doi: 10.1210/jc.2018-02703.

Efficacy and Safety of Alirocumab 300 mg Every 4 Weeks in Individuals With Type 2 Diabetes on Maximally Tolerated Statin.

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Department of Medicine I, University Hospital, RWTH Aachen University, Aachen, Germany.
Department of Medicine and Genetics, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennysylvania.
Department of Internal Medicine, Division of Clinical Pharmacology, University of Kansas Medical Center, Kansas City, Kansas.
Clinique des Maladies Lipidiques, Department of Medicine, Centre Hospitalier Universitaire de Québec - Université Laval, Québec, Canada.
Lipid Clinic, Oslo University Hospital, Oslo, Norway.
Imperial Centre for Cardiovascular Disease Prevention, Imperial College London, London, United Kingdom.
Regeneron Pharmaceuticals, Inc., Tarrytown, New York.
Sanofi, Paris, France.
The Sterling Research Group and University of Cincinnati, Cincinnati, Ohio.



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.


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 ≥70 mg/dL or ≥ 100 mg/dL, depending on cardiovascular risk, or if LDL-C reduction was <30% from baseline. Efficacy end points included percentage change from baseline to W24 for lipids, and time-averaged LDL-C over W21 to W24.


In individuals with T2DM, LDL-C reductions from baseline to W24 and the average of W21 to W24 were significantly greater with alirocumab (-61.6% and -68.8%, respectively) vs placebo. At W24, alirocumab significantly reduced levels of non-high-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-HDL-C <100 mg/dL and LDL-C <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.


In individuals with T2DM, alirocumab 300 mg Q4W was generally well tolerated and efficacious in reducing atherogenic lipoproteins.

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