Journal of the American Heart Association · 2017
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.
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Bays Harold E, Leiter Lawrence A, Colhoun Helen M, Thompson Desmond, Bessac Laurence, Pordy Robert, Toth Peter P
Аннотация
BACKGROUND: Non-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 RESULTS: This 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 <100 or <130 mg/dL for patients at very high and high cardiovascular risk, respectively; European Society of Cardiology/European Atherosclerosis Society guidelines: apoB <80 mg/dL for patients at very-high cardiovascular risk). Data were grouped according to comparator, alirocumab starting dose, and concomitant statin use. Compared with controls, alirocumab produced significantly greater reductions in non-HDL-C and apoB at Week 24 (P<0.0001), an effect extending up to 78 weeks. More alirocumab-treated patients achieved levels of non-HDL-C <100 mg/dL and apoB <80 mg/dL (P≤0.0001 versus control). By Week 24, >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.
CONCLUSIONS: Alirocumab 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.
METHODS AND RESULTS: This 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 <100 or <130 mg/dL for patients at very high and high cardiovascular risk, respectively; European Society of Cardiology/European Atherosclerosis Society guidelines: apoB <80 mg/dL for patients at very-high cardiovascular risk). Data were grouped according to comparator, alirocumab starting dose, and concomitant statin use. Compared with controls, alirocumab produced significantly greater reductions in non-HDL-C and apoB at Week 24 (P<0.0001), an effect extending up to 78 weeks. More alirocumab-treated patients achieved levels of non-HDL-C <100 mg/dL and apoB <80 mg/dL (P≤0.0001 versus control). By Week 24, >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.
CONCLUSIONS: Alirocumab 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.