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高剂量缓释烟酸对动脉粥样硬化和血管功能的影响:一项随机、安慰剂对照的磁共振成像研究。

Effects of high-dose modified-release nicotinic acid on atherosclerosis and vascular function: a randomized, placebo-controlled, magnetic resonance imaging study.

作者信息

Lee Justin M S, Robson Matthew D, Yu Ly-Mee, Shirodaria Cheerag C, Cunnington Colin, Kylintireas Ilias, Digby Janet E, Bannister Thomas, Handa Ashok, Wiesmann Frank, Durrington Paul N, Channon Keith M, Neubauer Stefan, Choudhury Robin P

机构信息

Department of Cardiovascular Medicine, University of Oxford and Oxford Centre for Clinical Magnetic Resonance Research (OCMR), Oxford, United Kingdom.

出版信息

J Am Coll Cardiol. 2009 Nov 3;54(19):1787-94. doi: 10.1016/j.jacc.2009.06.036.

Abstract

OBJECTIVES

Our aim was to determine the effects of high-dose (2 g) nicotinic acid (NA) on progression of atherosclerosis and measures of vascular function.

BACKGROUND

NA raises high-density lipoprotein cholesterol (HDL-C) and reduces low-density lipoprotein cholesterol and is widely used as an adjunct to statin therapy in patients with coronary artery disease. Although changes in plasma lipoproteins suggest potential benefit, there is limited evidence of the effects of NA on disease progression when added to contemporary statin treatment.

METHODS

We performed a double-blind, randomized, placebo-controlled study of 2 g daily modified-release NA added to statin therapy in 71 patients with low HDL-C (<40 mg/dl) and either: 1) type 2 diabetes with coronary heart disease; or 2) carotid/peripheral atherosclerosis. The primary end point was the change in carotid artery wall area, quantified by magnetic resonance imaging, after 1 year.

RESULTS

NA increased HDL-C by 23% and decreased low-density lipoprotein cholesterol by 19%. At 12 months, NA significantly reduced carotid wall area compared with placebo (adjusted treatment difference: -1.64 mm(2) [95% confidence interval: -3.12 to -0.16]; p = 0.03). Mean change in carotid wall area was -1.1 +/- 2.6 mm(2) for NA versus +1.2 +/- 3.0 mm(2) for placebo. In both the treatment and placebo groups, larger plaques were more prone to changes in size (r = 0.4, p = 0.04 for placebo, and r = -0.5, p = 0.02 for NA).

CONCLUSIONS

In statin-treated patients with low HDL-C, high-dose modified-release NA, compared with placebo, significantly reduces carotid atherosclerosis within 12 months. (Oxford Niaspan Study: Effects of Niaspan on Atherosclerosis and Endothelial Function; NCT00232531).

摘要

目的

我们的目标是确定高剂量(2克)烟酸(NA)对动脉粥样硬化进展和血管功能指标的影响。

背景

NA可提高高密度脂蛋白胆固醇(HDL-C)并降低低密度脂蛋白胆固醇,在冠心病患者中被广泛用作他汀类药物治疗的辅助药物。尽管血浆脂蛋白的变化提示可能有益,但在当代他汀类药物治疗基础上加用NA对疾病进展影响的证据有限。

方法

我们进行了一项双盲、随机、安慰剂对照研究,将71例HDL-C低(<40mg/dl)且符合以下情况之一的患者随机分为两组:1)2型糖尿病合并冠心病;或2)颈动脉/外周动脉粥样硬化,在他汀类药物治疗基础上加用每日2克缓释NA或安慰剂。主要终点是1年后通过磁共振成像定量的颈动脉壁面积变化。

结果

NA使HDL-C升高23%,使低密度脂蛋白胆固醇降低19%。12个月时,与安慰剂相比,NA显著降低了颈动脉壁面积(调整后的治疗差异:-1.64mm²[95%置信区间:-3.12至-0.16];p=0.03)。NA组颈动脉壁面积的平均变化为-1.1±2.6mm²,安慰剂组为+1.2±3.0mm²。在治疗组和安慰剂组中,较大的斑块更容易出现大小变化(安慰剂组r=0.4,p=0.04;NA组r=-0.5,p=0.02)。

结论

在接受他汀类药物治疗的HDL-C低的患者中,与安慰剂相比,高剂量缓释NA在12个月内可显著减轻颈动脉粥样硬化。(牛津烟酸缓释片研究:烟酸缓释片对动脉粥样硬化和内皮功能的影响;NCT00232531)

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