在接受胆固醇酯转移蛋白抑制治疗的血脂异常患者中比较低密度脂蛋白胆固醇方程。

Comparison of low-density lipoprotein cholesterol equations in patients with dyslipidaemia receiving cholesterol ester transfer protein inhibition.

机构信息

Ciccarone Center for the Prevention of Cardiovascular Disease, Division of Cardiology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.

NewAmsterdam Pharma B.V., Naarden, 1411 DC, The Netherlands.

出版信息

Eur Heart J Cardiovasc Pharmacother. 2023 Feb 2;9(2):148-155. doi: 10.1093/ehjcvp/pvac056.

DOI:10.1093/ehjcvp/pvac056

PMID:36307922

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9892865/

Abstract

AIMS

Low-density lipoprotein (LDL-C) lowering is imperative in cardiovascular disease prevention. We aimed to compare accuracy of three clinically-implemented LDL-C equations in a clinical trial of cholesterol ester transfer protein (CETP) inhibition.

METHODS AND RESULTS

Men and women aged 18-75 years with dyslipidaemia were recruited from 17 sites in the Netherlands and Denmark. Patients were randomly assigned to one of nine groups using various combinations of the CETP inhibitor TA-8995 (obicetrapib), statin therapy, and placebo. In pooled measurements over 12 weeks, we calculated LDL-C by the Friedewald, Martin/Hopkins, and Sampson equations, and compared values with preparative ultracentrifugation (PUC) LDL-C overall and with a special interest in the low LDL-C/high triglycerides subgroup. There were 242 patients contributing 921 observations. Overall median LDL-C differences between estimates and PUC were small: Friedewald, 0.00 (25th, 75th: -0.10, 0.08) mmol/L [0 (-4, 3) mg/dL]; Martin/Hopkins, 0.02 (-0.08, 0.10) mmol/L [1 (-3, 4) mg/dL]; and Sampson, 0.05 (-0.03, 0.15) mmol/L [2 (-1, 6) mg/dL]. In the subgroup with estimated LDL-C <1.8 mmol/L (<70 mg/dL) and triglycerides 1.7-4.5 mmol/L (150-399 mg/dL), the Friedewald equation underestimated LDL-C with a median difference versus PUC of -0.25 (-0.33, -0.10) mmol/L [-10 (-13, -4) mg/dL], whereas the median difference by Martin/Hopkins was 0.00 (-0.08, 0.10) mmol/L [0 (-3, 4) mg/dL] and by Sampson was -0.06 (-0.13, 0.00) mmol/L [-2 (-5, 0) mg/dL]. In this subgroup, the proportion of LDL-C observations <1.8 mmol/L (<70 mg/dL) that were correctly classified compared with PUC was 71.4% by Friedewald vs. 100.0% by Martin/Hopkins and 93.1% by Sampson.

CONCLUSION

In European patients with dyslipidaemia receiving a CETP inhibitor, we found improved LDL-C accuracy using contemporary equations vs. the Friedewald equation, and the greatest accuracy was observed with the Martin/Hopkins equation.

REGISTRATION

ClinicalTrials.gov, NCT01970215.

摘要

目的

降低低密度脂蛋白胆固醇（LDL-C）对心血管疾病的预防至关重要。我们旨在比较三种临床实施的 LDL-C 方程在胆固醇酯转移蛋白（CETP）抑制剂试验中的准确性。

方法和结果

17 个荷兰和丹麦地点招募了年龄在 18-75 岁、血脂异常的男性和女性。患者随机分为九组之一，使用 CETP 抑制剂 TA-8995（obicetrapib）、他汀类药物治疗和安慰剂的各种组合。在 12 周的综合测量中，我们通过 Friedewald、Martin/Hopkins 和 Sampson 方程计算 LDL-C，并总体上比较了与制备超速离心（PUC）LDL-C 的数值，并特别关注 LDL-C/高甘油三酯亚组。共有 242 名患者提供了 921 次观察。估计值与 PUC 之间 LDL-C 的总体中位数差异较小：Friedewald，0.00（25%，75%：-0.10，0.08）mmol/L [0（-4，3）mg/dL]；Martin/Hopkins，0.02（-0.08，0.10）mmol/L [1（-3，4）mg/dL]；Sampson，0.05（-0.03，0.15）mmol/L [2（-1，6）mg/dL]。在估计 LDL-C<1.8mmol/L（<70mg/dL）和甘油三酯 1.7-4.5mmol/L（150-399mg/dL）的亚组中，Friedewald 方程低估了 LDL-C，与 PUC 的中位数差异为-0.25（-0.33，-0.10）mmol/L [-10（-13，-4）mg/dL]，而 Martin/Hopkins 的中位数差异为 0.00（-0.08，0.10）mmol/L [0（-3，4）mg/dL]，Sampson 的中位数差异为-0.06（-0.13，0.00）mmol/L [-2（-5，0）mg/dL]。在该亚组中，与 PUC 相比，Friedewald 方程正确分类的 LDL-C 观察值<1.8mmol/L（<70mg/dL）的比例为 71.4%，而 Martin/Hopkins 方程为 100.0%，Sampson 方程为 93.1%。