Wong Nathan D, Fan Wenjun, Philip Sephy, Granowitz Craig, Toth Peter P
Heart Disease Prevention Program, Division of Cardiology, University of California, Irvine, California.
Heart Disease Prevention Program, Division of Cardiology, University of California, Irvine, California.
Am J Cardiol. 2020 Nov 1;134:62-68. doi: 10.1016/j.amjcard.2020.08.015. Epub 2020 Aug 16.
The reduction of cardiovascular events with icosapent ethyl-intervention (REDUCE-IT) trial showed in persons with prior cardiovascular disease (CVD) or diabetes mellitus (DM) that icosapent ethyl (IPE) reduced CVD events by 25%. We projected the preventable initial and total CVD events if REDUCE-IT trial eligibility criteria were applied to US adults. We identified US adults with available REDUCE-IT inclusion criteria from NHANES Surveys 1999-2016 and estimated primary (CVD death, nonfatal myocardial infarction, stroke, revascularization, or unstable angina) and secondary composite (CVD death, nonfatal MI or stroke) events using REDUCE-IT published event rates in the IPE and placebo groups, the difference being the number of preventable events. From 11,445 adults aged ≥45 years (representing 111.1 million [M]), a total of 319 persons (3.0 M) fit key REDUCE-IT eligibility criteria: triglycerides of 135 to 499 mg/dL, HbA1c <10%, blood pressure <200/100 mm Hg, and on a statin with LDL-C of 40 to 99 mg/dL. 63% had prior CVD and 37% had DM + ≥1 risk factor (primary prevention cohort). If these persons are given IPE for the REDUCE-IT median trial period of 4.9 years, we estimated preventing a total 349,817 (71,391/year) primary CVD outcomes of which 146,011 (29,798/year) were initial events. Most (24,151) preventable events were from the secondary prevention cohort. Using FDA eligibility criteria, an estimated 4.6 million persons would be eligible for IPE, with 60,544 preventable primary CVD outcomes annually from REDUCE-IT USA event rates. In conclusion, many CVD events in US adults with known CVD or DM and well-controlled LDL-C on statin therapy can be prevented with IPE.
二十碳五烯酸乙酯干预降低心血管事件（REDUCE-IT）试验表明，在既往有心血管疾病（CVD）或糖尿病（DM）的人群中，二十碳五烯酸乙酯（IPE）可使心血管疾病事件减少25%。我们预计了如果将REDUCE-IT试验纳入标准应用于美国成年人时可预防的初始和总的心血管疾病事件。我们从1999 - 2016年美国国家健康与营养检查调查（NHANES）中确定了具有可用REDUCE-IT纳入标准的美国成年人，并使用REDUCE-IT公布的IPE组和安慰剂组的事件发生率来估计主要（心血管疾病死亡、非致命性心肌梗死、中风、血运重建或不稳定型心绞痛）和次要复合（心血管疾病死亡、非致命性心肌梗死或中风）事件，两者的差异即为可预防事件的数量。在11445名年龄≥45岁的成年人（代表1.111亿人）中，共有319人（300万人）符合REDUCE-IT的关键纳入标准：甘油三酯为135至499mg/dL，糖化血红蛋白<10%，血压<200/100mmHg，且正在服用他汀类药物，低密度脂蛋白胆固醇为40至99mg/dL。63%的人既往有心血管疾病，37%的人患有糖尿病且有≥1个危险因素（一级预防队列）。如果这些人按照REDUCE-IT试验的中位时间4.9年给予IPE治疗，我们估计总共可预防349817例（每年71391例）主要心血管疾病结局，其中146011例（每年29798例）为初始事件。大多数（24151例）可预防事件来自二级预防队列。按照美国食品药品监督管理局（FDA）的纳入标准，估计有460万人符合使用IPE的条件，根据REDUCE-IT美国事件发生率，每年可预防60544例主要心血管疾病结局。总之，对于已知患有心血管疾病或糖尿病且在他汀类药物治疗下低密度脂蛋白胆固醇得到良好控制的美国成年人，IPE可预防许多心血管疾病事件。
