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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.

Author information

1
Department of Medicine I, University Hospital, RWTH Aachen University, Aachen, Germany.
2
Department of Medicine and Genetics, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennysylvania.
3
Department of Internal Medicine, Division of Clinical Pharmacology, University of Kansas Medical Center, Kansas City, Kansas.
4
Clinique des Maladies Lipidiques, Department of Medicine, Centre Hospitalier Universitaire de Québec - Université Laval, Québec, Canada.
5
Lipid Clinic, Oslo University Hospital, Oslo, Norway.
6
Imperial Centre for Cardiovascular Disease Prevention, Imperial College London, London, United Kingdom.
7
Regeneron Pharmaceuticals, Inc., Tarrytown, New York.
8
Sanofi, Paris, France.
9
The Sterling Research Group and University of Cincinnati, Cincinnati, Ohio.

Abstract

CONTEXT:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSION:

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

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