Author + information
- Peter P. Toth,
- Maciej Banach,
- Constantine Djedjos,
- Xiaoyun Yang,
- Mary Elliott,
- Mike Davis,
- Ransi Somaratne,
- Seth Martin and
- Steven Jones
Serum levels of low-density lipoprotein particles (LDL-P) are more highly correlated with risk for cardiovascular (CV) events than LDL-cholesterol (LDL-C). In this post hoc analysis we evaluated the impact of evolocumab therapy on serum levels of LDL-P in patients on diet alone, atorvastatin (ATV) monotherapy, or a combination of ATV/ezetimibe (EZE).
The DESCARTES trial was a 52-week placebo-controlled investigation of patients with hyperlipidemia who were stratified by risk to diet alone, ATV 10 mg/day, ATV 80 mg/day, or ATV 80 mg/day plus EZE 10 mg/day and then randomized 1:2 to placebo or evolocumab 420 mg monthly. We examined samples from 619 patients; samples were analyzed for lipoprotein particle concentrations and size using nuclear magnetic resonance. For lipid results (LDL, HDL [high-density lipoprotein cholesterol], triglycerides, and total cholesterol), baseline levels were calculated by taking the average of screening and day 1 values if available.
Overall, 56% (placebo) and 49% (evolocumab) were female; 83% and 78% were white, and 15% and 18% had coronary artery disease. LDL particle number, LDL-C, and total cholesterol all decreased significantly more with the addition of evolocumab than with placebo (Table). Changes in triglycerides and HDL-C were also observed.
Evolocumab therapy in patients already on ATV or ATV/EZE provides on average a 44% incremental reduction in LDL-P, a significant marker of risk for CV events.
|Placebo||Evolocumab 420 QM|
|n||Mean (SD)||Mean (SD)|
|LDL-P, day 1, nmol/L||269||1077.1 (274.5)||1100.2 (286)|
|LDL-P, week 52, nmol/L||236||1111.3 (326.1)||294||604.2 (322.2)|
|n||Mean (95% CI, or SE)||n||Mean (95% CI, or SE)|
|LDL-P, % change from baseline to week 52||236||6.4 (2.9, 9.9)||294||−44.1 (−47.2,-40.9)|
|LDL-C, % change from baseline to week 52||250||7.0 (1.8)||309||−53.0 (1.7)|
|HDL-C, % change from baseline to week 52||255||0.3 (0.9)||313||5.7 (0.9)|
|Triglycerides, % change from baseline to week 52||255||8.5 (2.6)||313||−3.3 (2.2)|
|TC, % change from baseline to week 52||255||4.7 (1.2)||313||−29.3 (1.0)|
LDL-P, low-density lipoprotein particle; LDL-C, low-density lipoprotein cholesterol; HDL-C, high-density lipoprotein cholesterol; TC, total cholesterol; QM, once every month; CI, confidence interval; SD, standard deviation; SE, standard error Sponsor: Amgen Inc.
Poster Area, South Hall A1
Saturday, April 02, 2016, 3:45 p.m.-4:30 p.m.
Session Title: Role of Biomarkers and Therapeutic Lifestyle in Preventive Cardiology
Abstract Category: 33. Prevention: Clinical
Presentation Number: 1156-368
- 2016 American College of Cardiology Foundation