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根据欧洲心脏病学会/欧洲动脉粥样硬化学会指南,不符合他汀类药物治疗条件的高甘油三酯血症患者的初级预防未满足需求:一项当代基于人群的研究。

Unmet need for primary prevention in individuals with hypertriglyceridaemia not eligible for statin therapy according to European Society of Cardiology/European Atherosclerosis Society guidelines: a contemporary population-based study.

机构信息

Department of Clinical Biochemistry, Herlev and Gentofte Hospital, Copenhagen University Hospital, Herlev Ringvej 75, 2730 Herlev, Denmark.

The Copenhagen General Population Study, Herlev and Gentofte Hospital, Copenhagen University Hospital, Denmark.

出版信息

Eur Heart J. 2018 Feb 14;39(7):610-619. doi: 10.1093/eurheartj/ehx659.

Abstract

AIMS

To identify individuals at high risk of atherosclerotic cardiovascular disease (ASCVD), who are not definite statin eligible according to the 2016 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) guidelines, based on high concentrations of plasma triglycerides.

METHODS AND RESULTS

From the Copenhagen General Population Study (2003-2015) 58 547 individuals aged 40-65 and free of ASCVD, diabetes, and statin use at baseline were included. Of these, 14% were definite statin eligible, 7% were not eligible and had triglycerides ≥3.0 mmol/L (264 mg/dL), and 79% were not statin eligible and had triglycerides <3.0 mmol/L (264 mg/dL). During 456 057 person-years of follow-up, 1770 individuals experienced a major adverse cardiovascular event (MACE) and 734 experienced a myocardial infarction (MI). The cumulative incidences of MACE at age 70 were 8.1% (95% confidence interval 7.3-8.9%) and 14.6% (12.6-16.8%) in statin non-eligible individuals with triglycerides <3.0 mmol/L (264 mg/dL) and ≥3.0 mmol/L (264 mg/dL), and 16.5% (14.0-19.3%) in statin eligible individuals. Corresponding cumulative incidences of MI were 3.0% (2.7-3.3%), 7.8% (6.4-9.5%), and 7.1% (5.9-8.4%), respectively. The estimated 10-year risks of MACE were 2.8% (2.6-3.0%) and 5.7% (4.9-6.6%) in statin non-eligible individuals with triglycerides <3.0 mmol/L (264 mg/dL) and ≥3.0 mmol/L (264 mg/dL), and 7.6% (6.9-8.3%) in statin eligible individuals; the median age in these three groups were 51, 51, and 60 years, respectively. Corresponding risks of MI were 1.0% (0.9-1.1%), 3.0% (2.4-3.7%), and 3.3% (2.8-3.7%), respectively.

CONCLUSION

Statin non-eligible individuals with triglycerides ≥3.0 mmol/L (264 mg/dL) had risk of ASCVD similar to statin eligible individuals, defined according to the 2016 ESC/EAS guidelines. This illustrates an unmet need for primary prevention, calling for expansion of guidelines on statin eligibility, and the potential for placebo-controlled randomized clinical trials in individuals with hypertriglyceridaemia.

摘要

目的

根据 2016 年欧洲心脏病学会/欧洲动脉粥样硬化学会(ESC/EAS)指南,确定不符合他汀类药物适应证但血浆甘油三酯浓度较高的动脉粥样硬化性心血管疾病(ASCVD)高危人群。

方法和结果

本研究纳入了来自哥本哈根普通人群研究(2003-2015 年)的 58547 名年龄在 40-65 岁之间、基线时无 ASCVD、糖尿病和他汀类药物使用史的个体。其中,14%为明确的他汀类药物适应证患者,7%为不符合适应证但甘油三酯≥3.0mmol/L(264mg/dL)的患者,79%为不符合他汀类药物适应证且甘油三酯<3.0mmol/L(264mg/dL)的患者。在 456057 人年的随访期间,1770 名患者发生了主要不良心血管事件(MACE),734 名患者发生了心肌梗死(MI)。70 岁时 MACE 的累积发生率在甘油三酯<3.0mmol/L(264mg/dL)和≥3.0mmol/L(264mg/dL)的他汀类药物非适应证患者中分别为 8.1%(95%置信区间 7.3-8.9%)和 14.6%(12.6-16.8%),在他汀类药物适应证患者中为 16.5%(14.0-19.3%)。相应的 MI 累积发生率分别为 3.0%(2.7-3.3%)、7.8%(6.4-9.5%)和 7.1%(5.9-8.4%)。在甘油三酯<3.0mmol/L(264mg/dL)和≥3.0mmol/L(264mg/dL)的他汀类药物非适应证患者中,估计的 10 年 MACE 风险分别为 2.8%(2.6-3.0%)和 5.7%(4.9-6.6%),在他汀类药物适应证患者中为 7.6%(6.9-8.3%);这三组患者的中位年龄分别为 51、51 和 60 岁。相应的 MI 风险分别为 1.0%(0.9-1.1%)、3.0%(2.4-3.7%)和 3.3%(2.8-3.7%)。

结论

根据 2016 年 ESC/EAS 指南,甘油三酯≥3.0mmol/L(264mg/dL)的他汀类药物非适应证患者发生 ASCVD 的风险与他汀类药物适应证患者相似。这表明初级预防存在未满足的需求,需要扩大他汀类药物适应证指南,并有可能在高甘油三酯血症患者中进行安慰剂对照随机临床试验。

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