Alirocumab Treatment and Achievement of Non‐High‐Density Lipoprotein Cholesterol and Apolipoprotein B Goals in Patients With Hypercholesterolemia: Pooled Results From 10 Phase 3 ODYSSEY Trials

Abstract

BackgroundNon‐high‐density lipoprotein cholesterol (non‐HDL‐C) and apolipoprotein (apo) B are better predictors of atherosclerotic cardiovascular disease risk than low‐density lipoprotein cholesterol alone. US and European lipid management guidelines support non‐HDL‐C and apoB as targets for lipid‐lowering therapy. Methods and ResultsThis analysis evaluated the efficacy of alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, on non‐HDL‐C and apoB. Data were derived from 4983 patients enrolled in 10 randomized, placebo‐ or ezetimibe‐controlled Phase 3 ODYSSEY trials. Primary end point for this pooled analysis was percent reduction in non‐HDL‐C and apoB at Week 24; secondary end points included the percentage of patients achieving guideline‐directed treatment goals (National Lipid Association guidelines: non‐HDL‐C 70% of alirocumab‐treated patients on background statin achieved non‐HDL‐C <100 or <130 mg/dL, and apoB <80 mg/dL. Safety was comparable across pooled groups and in line with previous reports. ConclusionsAlirocumab produced significant, sustained reductions in non‐HDL‐C and apoB, allowing more patients to achieve lipid goals compared with placebo or ezetimibe and irrespective of maximally tolerated statin use.

Keywords

• alirocumab
• apolipoprotein B
• cholesterol‐lowering
• hypercholesterolemia
• non‐high‐density lipoprotein cholesterol
• PCSK9