Efficacy and safety of alirocumab in individuals with type 2 diabetes mellitus with or without mixed dyslipidaemia : Analysis of the ODYSSEY LONG TERM trial

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Taskinen , M-R , Del Prato , S , Bujas-Bobanovic , M , Louie , M J , Letierce , A , Thompson , D & Colhoun , H M 2018 , ' Efficacy and safety of alirocumab in individuals with type 2 diabetes mellitus with or without mixed dyslipidaemia : Analysis of the ODYSSEY LONG TERM trial ' , Atherosclerosis , vol. 276 , pp. 124-130 . https://doi.org/10.1016/j.atherosclerosis.2018.07.017

Title: Efficacy and safety of alirocumab in individuals with type 2 diabetes mellitus with or without mixed dyslipidaemia : Analysis of the ODYSSEY LONG TERM trial
Author: Taskinen, Marja-Riitta; Del Prato, Stefano; Bujas-Bobanovic, Maja; Louie, Michael J.; Letierce, Alexia; Thompson, Desmond; Colhoun, Helen M.
Contributor: University of Helsinki, Clinicum
Date: 2018-09
Language: eng
Number of pages: 7
Belongs to series: Atherosclerosis
ISSN: 0021-9150
URI: http://hdl.handle.net/10138/243767
Abstract: Background and aims: Alirocumab, a monoclonal antibody to proprotein convertase subtilisin/kexin type 9, significantly reduces low-density lipoprotein cholesterol (LDL-C). We evaluated the efficacy and safety of alirocumab in individuals with type 2 diabetes mellitus (T2DM) with versus without mixed dyslipidaemia (MDL, defined as baseline LDL-C >= 70 mg/dL [1.8 mmol/L] and triglycerides >= 150mg/dL [1.7 mmol/L]). Methods: Data from 812 individuals with T2DM, from the placebo-controlled, 78-week, Phase 3 ODYSSEY LONG TERM trial of alirocumab 150mg every 2 weeks (Q2W), on a background of maximally tolerated statins +/- other lipid-lowering therapies, were pooled according to MDL status. Efficacy endpoints included percentage change from baseline to Week 24 in calculated LDL-C and other lipids/lipoproteins. Results: In individuals with T2DM who received alirocumab 150mg Q2W, mean LDL-C changes from baseline to Week 24 were -62.6% (vs. -6.0% with placebo) in those with MDL and -56.1% (vs. 5.6%) in those without MDL, with no significant between-group difference (p-interaction = 0.0842). Risk-based LDL-C goals ( Conclusions: Reductions in LDL-C and other lipids with alirocumab, as well as safety and tolerability, were comparable between individuals with T2DM and with versus without MDL. (c) 2018 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Subject: Alirocumab
Type 2 diabetes mellitus
Cardiovascular risk
Cholesterol-lowering drugs
Low-density lipoprotein cholesterol
Proprotein convertase subtilisin/kexin type 9
DENSITY-LIPOPROTEIN CHOLESTEROL
HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
ATHEROSCLEROTIC CARDIOVASCULAR-DISEASE
PCSK9 INHIBITOR EVOLOCUMAB
AMERICAN-COLLEGE
POOLED ANALYSIS
RISK PATIENTS
CLINICAL ENDOCRINOLOGISTS
MONOCLONAL-ANTIBODY
ATHEROGENIC LIPIDS
3121 General medicine, internal medicine and other clinical medicine
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