%0 Journal Article
%A Leiter, Lawrence A
%A Cariou, Bertrand
%A Müller-Wieland, Dirk
%A Colhoun, Helen M
%A Del Prato, Stefano
%A Tinahones, Francisco J
%A Ray, Kausik K
%A Bujas-Bobanovic, Maja
%A Domenger, Catherine
%A Mandel, Jonas
%A Samuel, Rita
%A Henry, Robert R
%T Efficacy and safety of alirocumab in insulin-treated individuals with type 1 or type 2 diabetes and high cardiovascular risk: The ODYSSEY DM-INSULIN randomized trial.
%D 2017
%U http://hdl.handle.net/10668/11579
%X To investigate the efficacy and safety of alirocumab in participants with type 2 (T2D) or type 1 diabetes (T1D) treated with insulin who have elevated LDL cholesterol levels despite maximally tolerated statin therapy. Participants at high cardiovascular risk with T2D (n = 441) or T1D (n = 76) and LDL cholesterol levels ≥1.8 mmol/L (≥70 mg/dL) were randomized 2:1 to alirocumab:placebo administered subcutaneously every 2 weeks, for 24 weeks' double-blind treatment. Alirocumab-treated participants received 75 mg every 2 weeks, with blinded dose increase to 150 mg every 2 weeks at week 12 if week 8 LDL cholesterol levels were ≥1.8 mmol/L. Primary endpoints were percentage change in calculated LDL cholesterol from baseline to week 24, and safety assessments. Alirocumab reduced LDL cholesterol from baseline to week 24 by a mean ± standard error of 49.0% ± 2.7% and 47.8% ± 6.5% vs placebo (both P  Alirocumab produced significant LDL cholesterol reductions in participants with insulin-treated diabetes regardless of diabetes type, and was generally well tolerated. Concomitant administration of alirocumab and insulin did not raise any safety concerns (NCT02585778).
%K cardiovascular disease
%K clinical trial
%K lipid-lowering therapy
%K type 1 diabetes
%K type 2 diabetes
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