Department of Pharmacotherapy & Outcomes Science, Virginia Commonwealth University School of Pharmacy, Richmond, Va.
Am J Med. 2020 Jul;133(7):802-804. doi: 10.1016/j.amjmed.2020.03.006. Epub 2020 Mar 31.
For decades, omega-3 fatty acids (O3FA) have been used for their cardioprotective effects. Although several prescription products are available, icosapent ethyl (IPE) is the lone pure, eicosapentaenoic acid (EPA)-only, O3FA product. Initially approved by the Food and Drug Administration (FDA) to reduce triglyceride (TG) levels in patients with TG levels ≥500 mg/dL, the Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial (REDUCE-IT) demonstrated that IPE reduces cardiovascular events in patients with either established atherosclerotic cardiovascular disease (ASCVD) or diabetes plus ≥2 ASCVD risk factors, a TG level between 135 mg/dL and 499 mg/dL, and who were taking a statin. IPE is generally well tolerated, but caution is advised if used in patients taking antiplatelet or anticoagulant therapies because of an increased risk of bleeding. Based on the REDUCE-IT trial, the Food and Drug Administration granted IPE an indication for ASCVD risk reduction, making it the first O3FA product to receive such an indication. IPE is a cost-effective approach to reducing residual cardiovascular risk in high risk patients treated with statins.
几十年来,ω-3 脂肪酸(O3FA)一直因其对心脏的保护作用而被使用。尽管有几种处方产品,但只有埃克萨帕坦乙酯(IPE)是一种纯二十碳五烯酸(EPA)、O3FA 产品。IPE 最初被美国食品和药物管理局(FDA)批准用于降低甘油三酯(TG)水平在 TG 水平≥500mg/dL 的患者中,心血管事件减少与埃克萨帕坦乙酯干预试验(REDUCE-IT)表明,IPE 降低了患有明确动脉粥样硬化性心血管疾病(ASCVD)或糖尿病加≥2 个 ASCVD 风险因素、TG 水平在 135mg/dL 和 499mg/dL 之间且正在服用他汀类药物的患者的心血管事件。IPE 通常耐受性良好,但如果在正在服用抗血小板或抗凝治疗的患者中使用,应谨慎,因为出血风险增加。基于 REDUCE-IT 试验,美国食品和药物管理局批准 IPE 用于降低 ASCVD 风险,使其成为第一个获得此类适应症的 O3FA 产品。IPE 是降低用他汀类药物治疗的高危患者剩余心血管风险的一种具有成本效益的方法。