Simvastatin with or without ezetimibe in familial hypercholesterolemia
Simvastatin with or without ezetimibe in familial hypercholesterolemia
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DOI：
10.1056/nejmoa0800742
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发表时间：
2008-04-03
影响因子：
158.5
通讯作者：
de Groot, Eric
中科院分区：
文献类型：
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作者：
Kastelein, John J. P.;Akdim, Fatima;de Groot, Eric
背景：依折麦布是一种胆固醇吸收抑制剂，当与他汀类药物联合治疗时，可降低低密度脂蛋白（LDL）胆固醇水平。然而，依折麦布对动脉粥样硬化进展的影响仍然未知。方法：我们进行了一项双盲，随机，为期24个月的试验，比较每日治疗的影响与80毫克的辛伐他汀或安慰剂或10毫克的依折麦布在720例家族性高胆固醇血症。患者接受B型超声检查，以评估颈动脉和股动脉壁的内膜中层厚度。主要结果指标是平均颈动脉内膜-中层厚度的变化，其定义为左右颈总动脉、颈动脉球和颈内动脉的远壁内膜-中层厚度的平均值。主要结局，颈动脉内膜中层厚度的平均（+/-SE）变化，单用辛伐他汀组为0.0058 ± 0.0037 mm，辛伐他汀加依折麦布（联合治疗）组为0.0111 ± 0.0038 mm（P=0.29）。次要结局（包括颈动脉和股动脉内膜中层厚度的其他变量）在两组之间没有显著差异。研究结束时，辛伐他汀组的平均（+/-SD）LDL胆固醇水平为192.7+/-60.3 mg/dl（4.98+/-1.56 mmol/L），联合治疗组为141.3+/-52.6 mg/dl（3.65+/-1.36 mmol/L）（组间差异为16.5%，P
Background: Ezetimibe, a cholesterol-absorption inhibitor, reduces levels of low-density lipoprotein (LDL) cholesterol when added to statin treatment. However, the effect of ezetimibe on the progression of atherosclerosis remains unknown.Methods: We conducted a double-blind, randomized, 24-month trial comparing the effects of daily therapy with 80 mg of simvastatin either with placebo or with 10 mg of ezetimibe in 720 patients with familial hypercholesterolemia. Patients underwent B-mode ultrasonography to assess the intima-media thickness of the walls of the carotid and femoral arteries. The primary outcome measure was the change in the mean carotid-artery intima-media thickness, which was defined as the average of the means of the far-wall intima-media thickness of the right and left common carotid arteries, carotid bulbs, and internal carotid arteries.Results: The primary outcome, the mean (+/-SE) change in the carotid-artery intima-media thickness, was 0.0058+/-0.0037 mm in the simvastatin-only group and 0.0111+/-0.0038 mm in the simvastatin-plus-ezetimibe (combined-therapy) group (P=0.29). Secondary outcomes (consisting of other variables regarding the intima-media thickness of the carotid and femoral arteries) did not differ significantly between the two groups. At the end of the study, the mean (+/-SD) LDL cholesterol level was 192.7+/-60.3 mg per deciliter (4.98+/-1.56 mmol per liter) in the simvastatin group and 141.3+/-52.6 mg per deciliter (3.65+/-1.36 mmol per liter) in the combined-therapy group (a between-group difference of 16.5%, P