VYTAL 试验中依折麦布/辛伐他汀与阿托伐他汀在 2 型糖尿病患者中的脂蛋白和载脂蛋白比值比较。

Lipoprotein and apolipoprotein ratios in the VYTAL trial of ezetimibe/simvastatin compared with atorvastatin in type 2 diabetes.

机构信息

Department of Medicine, Division of Endocrinology, Metabolism and Nutrition, Box 3510, Duke University, Durham, NC 27710, USA.

出版信息

J Clin Lipidol. 2008 Feb;2(1):19-24. doi: 10.1016/j.jacl.2007.12.004. Epub 2008 Jan 6.

DOI:10.1016/j.jacl.2007.12.004

PMID:21291711

Abstract

BACKGROUND

Type 2 diabetes mellitus (T2DM) is associated with a high risk for coronary heart disease (CHD). A variety of lipoprotein and apolipoprotein (Apo) ratios have been proposed that may reflect the balance of cholesterol delivery and removal at the arterial wall and provide an assessment of CHD risk that is supplemental to low-density lipoprotein cholesterol (LDL-C), the primary guide for cholesterol-lowering therapy in patients at risk.

OBJECTIVE

To examine changes in lipoprotein and apolipoprotein ratios in the VYTAL trial of hypercholesterolemic patients with T2DM.

METHODS

Changes in the ratios LDL-C/high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC)/HDL-C, non-HDL-C/HDL-C, and ApoB/ApoA-I were assessed in this randomized, double-blind, parallel-group study that enrolled T2DM patients with LDL-C ≥100 mg/dL for 6-week treatments with either the usual daily starting doses of atorvastatin (ATORVA) 10 or 20 mg or ezetimibe/simvastatin (EZE/SIMVA) 10/20 mg, or the next highest doses (ATORVA 40 mg, EZE/SIMVA 10/40 mg). Changes in lipoprotein and apolipoprotein ratios, prespecified exploratory endpoints, were analyzed using analysis of variance.

RESULTS

Efficacy results were based on 1198 patients with sufficient data among 1229 randomized patients. Baseline lipoproteins, apolipoproteins, and ratios were comparable among treatment groups. EZE/SIMVA produced significantly greater reductions compared with ATORVA in each lipoprotein or apolipoprotein ratio at each dose comparison (P < 0.001). For example, reductions from baseline in TC/HDL-C were ATORVA 10 mg, -30.2%; ATORVA 20 mg -34.9%; EZE/SIMVA 10/20 mg, -41.6%; ATORVA 40 mg, -37.9%; and EZE/SIMVA 10/40 mg, -43.5%. Tolerability of the two treatments was similar.

CONCLUSION

For the doses assessed, EZE/SIMVA was more effective compared with ATORVA in lowering the lipoprotein and apolipoprotein ratios that might be considered secondary measures of CHD risk.

摘要

背景

2 型糖尿病（T2DM）与冠心病（CHD）风险增加有关。已经提出了多种脂蛋白和载脂蛋白（Apo）比值，这些比值可能反映了胆固醇在动脉壁中的输送和清除之间的平衡，并提供了对 CHD 风险的评估，该评估是对有风险的患者的低密度脂蛋白胆固醇（LDL-C）降低治疗的补充，LDL-C 是胆固醇降低治疗的主要指南。

目的

在 T2DM 高胆固醇血症患者的 VYTAL 试验中检查脂蛋白和载脂蛋白比值的变化。

方法

在这项随机、双盲、平行组研究中，评估了 LDL-C/高密度脂蛋白胆固醇（HDL-C）、总胆固醇（TC）/HDL-C、非 HDL-C/HDL-C 和 ApoB/ApoA-I 比值的变化。该研究纳入了 LDL-C≥100mg/dL 的 T2DM 患者，进行为期 6 周的治疗，分别接受阿托伐他汀（ATORVA）10 或 20mg 或依折麦布/辛伐他汀（EZE/SIMVA）10/20mg 的常规起始剂量或更高剂量（ATORVA 40mg，EZE/SIMVA 10/40mg）。使用方差分析对脂蛋白和载脂蛋白比值的变化进行了分析，这些变化是预先指定的探索性终点。

结果

疗效结果基于 1229 名随机患者中 1198 名有足够数据的患者。在每个治疗组中，基线脂蛋白、载脂蛋白和比值均具有可比性。与 ATORVA 相比，EZE/SIMVA 在每个剂量比较中，每个脂蛋白或载脂蛋白比值的降低幅度均显著更大（P<0.001）。例如，TC/HDL-C 从基线的降低幅度为 ATORVA 10mg，-30.2%；ATORVA 20mg，-34.9%；EZE/SIMVA 10/20mg，-41.6%；ATORVA 40mg，-37.9%；EZE/SIMVA 10/40mg，-43.5%。两种治疗的耐受性相似。