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Alirocumab therapy in individuals with type 2 diabetes mellitus and atherosclerotic cardiovascular disease: Analysis of the ODYSSEY DM-DYSLIPIDEMIA and DM-INSULIN studies

Cardiovascular Diabetology Nov 20, 2019

Ray KK, Del Prato S, Müller-Wieland D, et al. - Among participants of ODYSSEY DM-DYSLIPIDEMIA and DM-INSULIN studies, researchers determined whether alirocumab (a proprotein convertase subtilisin/kexin type 9 inhibitor) would display efficacy and safety as a treatment option in people with type 2 diabetes (T2DM), high low-density lipoprotein cholesterol (LDL-C) or non-high-density lipoprotein cholesterol (non-HDL-C), and established atherosclerotic cardiovascular disease (ASCVD) taking maximally tolerated statin. Randomization of people with T2DM and mixed dyslipidemia (non-HDL-C ≥ 100 mg/dL; n = 413) to open-label alirocumab 75 mg every 2 weeks (Q2W) or usual care (UC) for 24 weeks was done in DM-DYSLIPIDEMIA, with UC options chosen prior to stratified randomization. In a double-blind fashion, randomization of insulin-treated people with T2DM (LDL-C ≥ 70 mg/dL; n = 441) to alirocumab 75 mg Q2W or placebo for 24 weeks was done in DM-INSULIN. Findings revealed a significant decrease in atherogenic cholesterol and LDL particle number in relation to alirocumab treatment in people with T2DM and ASCVD with high non-HDL-C/LDL-C levels despite maximally tolerated statin vs control. The general good tolerability of alirocumab was also evident in this analysis.
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