烟酸在升高高密度脂蛋白胆固醇以降低动脉粥样硬化性心血管疾病患者心血管事件方面的作用，以及最佳治疗后的低密度脂蛋白胆固醇。 理由和研究设计。代谢综合征伴低 HDL/高甘油三酯患者中的动脉血栓形成干预：对全球健康结局的影响（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).
机构信息
Axio Research, LLC, Seattle, WA, USA.
出版信息
Am Heart J. 2011 Mar;161(3):471-477.e2. doi: 10.1016/j.ahj.2010.11.017. Epub 2011 Feb 2.
BACKGROUND
The aim of this study was to test the hypothesis that patients with atherosclerotic cardiovascular (CV) disease optimally treated on a statin but with residual atherogenic dyslipidemia (low high-density lipoprotein cholesterol [HDL-C] and high triglycerides) will benefit from addition of niacin with fewer CV events compared with placebo. Statin monotherapy trials have found 25%-35% CV risk reduction relative to placebo, leaving significant residual risk. Patients with atherogenic dyslipidemia have substantially increased CV risk.
METHODS
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 low-density lipoprotein cholesterol (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 the following: coronary heart disease death, nonfatal 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.
RESULTS
AIM-HIGH completed enrollment in April 2010. Follow-up is expected to continue through 2012.
SUMMARY
AIM-HIGH was designed to determine whether treating residual dyslipidemia with niacin further reduces cardiovascular events in patients with CV disease on a statin at target levels of low-density lipoprotein cholesterol.
背景
本研究旨在验证以下假设，即对于接受他汀类药物充分治疗但仍存在动脉粥样硬化性血脂异常（低高密度脂蛋白胆固醇[HDL-C]和高甘油三酯血症）的动脉粥样硬化性心血管（CV）疾病患者，与安慰剂相比，加用烟酸治疗将减少 CV 事件，从而获益。他汀类药物单药治疗试验发现，与安慰剂相比，CV 风险降低了 25%-35%，但仍存在显著的残余风险。存在血脂异常的动脉粥样硬化患者具有显著增加的 CV 风险。
方法
参与者为患有已确诊的 CV 疾病和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的他汀类药物剂量而异。所有参与者均接受辛伐他汀（或辛伐他汀加依折麦布）治疗，剂量足以将 LDL-C 维持在 40-80mg/dL（1.03-2.07mmol/L）。参与者被随机分配至烟酸缓释剂或匹配的安慰剂。主要终点是首次发生以下任何一种情况的时间：冠心病死亡、非致死性心肌梗死、缺血性卒、因急性冠脉综合征住院或因症状驱动进行冠脉或脑血运重建。该事件驱动的试验将有 85%的效能显示在 850 例患者发生主要终点事件后，主要终点事件的频率降低 25%。
结果
AIM-HIGH 于 2010 年 4 月完成入组。预计随访将持续到 2012 年。
总结
AIM-HIGH 旨在确定用烟酸治疗残余血脂异常是否进一步降低了接受他汀类药物治疗且 LDL-C 达到目标水平的 CV 疾病患者的 CV 事件。
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