The role of niacin in raising high-density lipoprotein cholesterol to reduce cardiovascular events in patients with atherosclerotic cardiovascular disease and optimally treated low-density lipoprotein cholesterol Rationale and study design. The Atherothrombosis Intervention in Metabolic syndrome with low HDL/high triglycerides: Impact on Global Health outcomes (AIM-HIGH).

The role of niacin in raising high-density lipoprotein cholesterol to reduce cardiovascular events in patients with atherosclerotic cardiovascular disease and optimally treated low-density lipoprotein cholesterol Rationale and study design. The Atherothrombosis Intervention in Metabolic syndrome with low HDL/high triglycerides: Impact on Global Health outcomes (AIM-HIGH).
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DOI:
10.1016/j.ahj.2010.11.017
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发表时间:
2011-03
影响因子:
4.8
通讯作者:
Padley, Robert J.
Padley, Robert J.
中科院分区:
医学2区
文献类型:
--
作者:
Brown, B. Gregory;Boden, William E.;Probstfield, Jeffrey R.;McBride, Ruth;Anderson, Todd;Chaitman, Bernard;Marcovina, Santica;Weintraub, William;Zhao, Xue-Qiao;Teo, Koon;Kaiser, Judith;Desvignes-Nickens, Patrice;Fleg, Jerome L.;McGovern, Mark E.;Stolzenbach, James C.;Padley, Robert J.

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检验以下假设:接受他汀类药物最佳治疗但存在残余致动脉粥样硬化性血脂异常(低HDL-C和高甘油三酯)的动脉粥样硬化性心血管(CV)疾病患者将从添加烟酸中获益,与安慰剂相比CV事件更少。他汀类药物单药治疗试验发现,相对于安慰剂,CV风险降低了25-40%,留下了显著的剩余风险。致动脉粥样硬化性血脂异常患者的CV风险显著增加。受试者为确诊CV疾病和致动脉粥样硬化性血脂异常的男性和女性。血脂入选标准因性别和筛选时他汀类药物剂量而异。所有受试者均接受辛伐他汀(或辛伐他汀加依折麦布),剂量足以维持LDL-C 40 - 80 mg/dL(1.03 - 2.07 mmol/L)。参与者被随机分配到缓释烟酸或匹配的安慰剂组。主要终点是发生以下事件的时间:冠心病死亡、非致死性心肌梗死、缺血性卒中、急性冠脉综合征住院治疗或脑血管病驱动的冠状动脉或脑血管重建。这项事件驱动试验将有85%的把握度显示,在850例患者发生主要结局事件后,主要事件频率降低25%。AIM-HIGH于2010年4月完成入组。后续行动预计将持续到2012年。AIM-HIGH旨在确定在LDL-C目标水平下使用他汀类药物的CVD患者中,使用烟酸治疗残余血脂异常是否进一步降低心血管事件。
To test the hypothesis that patients with atherosclerotic cardiovascular (CV) disease optimally treated on a statin but with residual atherogenic dyslipidemia (low HDL-C and high triglycerides) will benefit from addition of niacin with fewer CV events compared with placebo. Statin monotherapy trials have found 25–40% CV risk reduction relative to placebo, leaving significant residual risk. Patients with atherogenic dyslipidemia have substantially increased CV risk. Participants were men and women with established CV disease and atherogenic dyslipidemia. Lipid entry criteria varied by gender and statin dose at screening. All participants received simvastatin (or simvastatin plus ezetimibe) at a dose sufficient to maintain LDL-C 40 - 80 mg/dL (1.03 – 2.07 mmol/L). Participants were randomized to extended-release niacin or matching placebo. The primary end-point was time to occurrence of the first of: coronary heart disease death, non-fatal myocardial infarction, ischemic stroke, hospitalization for acute coronary syndrome, or symptom-driven coronary or cerebral revascularization. This event-driven trial will have 85% power to show a 25% reduction in primary event frequency after 850 patients have experienced a primary outcome event. AIM-HIGH completed enrollment in April 2010. Follow-up is expected to continue through 2012. AIM-HIGH was designed to determine whether treating residual dyslipidemia with niacin further reduces cardiovascular events in patients with CVD on a statin at target levels of LDL-C.
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