Effects of aggressive versus conventional lipid-lowering therapy by simvastatin on human atherosclerotic lesions - A prospective, randomized, double-blind trial with high-resolution magnetic resonance imaging
Effects of aggressive versus conventional lipid-lowering therapy by simvastatin on human atherosclerotic lesions - A prospective, randomized, double-blind trial with high-resolution magnetic resonance imaging
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DOI：
10.1016/j.jacc.2005.03.054
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发表时间：
2005-07-05
影响因子：
24
通讯作者：
Badimon, JJ
中科院分区：
文献类型：
--
作者：
Corti, R;Fuster, V;Badimon, JJ
本研究旨在使用连续非侵入性磁共振成像（MRI）比较两种不同剂量的相同他汀类药物对早期人类动脉粥样硬化病变的积极和常规降脂作用。将新诊断的患有无症状主动脉和/或颈动脉粥样硬化斑块的高胆固醇血症患者（n = 51）随机分配至20 mg/天（n = 29）或80 mg/天（n = 22）辛伐他汀组。平均随访18.1个月。共检测到93个主动脉斑块和57个颈动脉斑块，并在开始降脂治疗后每6个月进行MRI随访。主要的MRI终点是血管壁面积（VWA）的变化作为动脉粥样硬化burner. Results的替代品，两种剂量的他汀类药物均显著降低总胆固醇（TC）和低密度脂蛋白胆固醇（LDL-C）与基线相比（p < 0.001）。常规（20 mg）辛伐他汀组与积极（80 mg）辛伐他汀组的总胆固醇分别降低26%和33%，LDL-C分别降低36%和46%。尽管辛伐他汀80 mg组的基线TC和LDL-C水平显着较高，但两组在治疗后达到了相似的绝对值。12个月时已经观察到VWA显著降低。在随机化剂量之间未检测到血管效应差异。事后分析显示，达到平均治疗中LDL-C的患者
OBJECTIVES This study sought to compare the effects of aggressive and conventional lipid lowering by two different dosages of the same statin on early human atherosclerotic lesions using serial noninvasive magnetic resonance imaging (MRI).BACKGROUND Regression of atherosclerotic lesions by lipid-lowering therapy has been reported.METHODS Using a double-blind design, newly diagnosed hypercholesterolemic patients (n = 51) with asymptomatic aortic and/or carotid atherosclerotic plaques were randomized to 20 mg/day (n = 29) or 80 mg/day (n = 22) simvastatin. Mean follow-up was 18.1 months. A total of 93 aortic and 57 carotid plaques were detected and sequentially followed up by MRI every six months after lipid-lowering initiation. The primary MRI end point was change in vessel wall area (VWA) as a surrogate for atherosclerotic burden.RESULTS Both statin doses reduced significantly total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) versus baseline (p < 0.001). Total cholesterol decreased by 26% versus 33% and LDL-C by 36% versus 46% in the conventional (20 mg) versus aggressive (80 mg) simvastatin groups, respectively. Although the simvastatin 80-mg group had significantly higher baseline TC and LDL-C levels, both groups reached similar absolute values after treatment. A significant reduction in VWA was already observed by 12 months. No difference on vascular effects was detected between the randomized doses. Post-hoc analysis showed that patients reaching mean on-treatment LDL-C