Hilleman Daniel, Smer Aiman
Manag Care. 2016 Jan;25(1):46-52.
To provide an overview of prescription and dietary supplement omega-3 fatty acid (OM3-FA) products and considerations for clinical use.
Narrative review.
The PubMed database was searched for cardiovascular-related investigations focused on eicosapentaenoic acid (EPA) and/or docosahexaenoic acid (DHA) (limit: English-only articles). Additional regulatory information on prescription and dietary supplements was obtained from United States Food and Drug Administration online sources.
Prescription QM3-FA products are supported by robust clinical development and safety monitoring programs, whereas dietary supplements are not required to demonstrate safety or efficacy prior to marketing. There are no over-the-counter OM3-FA products available in the United States. Investigations of OM3-FA dietary supplements show that quantities of EPA and DHA are highly variable within and between brands. Dietary supplements also may contain potentially harmful components, including oxidized OM3-FA, other lipids, cholesterol, and toxins. Prescription OM3-FA products may contain DHA and EPA or EPA alone. All prescription OM3-FA products have demonstrated statistically significant triglyceride reduction as monotherapy or in combination with statins in patients with hypertriglyceridemia. Differential effects between products containing EPA and DHA compared with a high-purity EPA product (icosapent ethyl) have clinical implications: Increases in low-density lipoprotein cholesterol associated with DHA have the potential to confound strategies for managing patients with dyslipidemia. Cardiovascular outcomes studies of prescription CM3-FA products are ongoing.
OM3-FA dietary supplements should not be substituted for prescription products, and prescription OM3-FA products that contain DHA are not equivalent to or interchangeable with high-purity EPA (icosapent ethyl) and should not be substituted for it.
概述处方和膳食补充剂ω-3脂肪酸（OM3-FA）产品以及临床使用的注意事项。
叙述性综述。
在PubMed数据库中检索聚焦于二十碳五烯酸（EPA）和/或二十二碳六烯酸（DHA）的心血管相关研究（限制条件：仅英文文章）。关于处方和膳食补充剂的其他监管信息从美国食品药品监督管理局在线资源获取。
处方OM3-FA产品有强大的临床研发和安全监测项目支持，而膳食补充剂在上市前无需证明安全性或有效性。在美国没有非处方OM3-FA产品。对OM3-FA膳食补充剂的研究表明，不同品牌内部和之间的EPA和DHA含量差异很大。膳食补充剂还可能含有潜在有害成分，包括氧化的OM3-FA、其他脂质、胆固醇和毒素。处方OM3-FA产品可能含有DHA和EPA或仅含EPA。所有处方OM3-FA产品在高甘油三酯血症患者中作为单一疗法或与他汀类药物联合使用时均已证明有统计学显著的甘油三酯降低效果。含EPA和DHA的产品与高纯度EPA产品（二十碳五烯酸乙酯）之间的差异效应具有临床意义：与DHA相关的低密度脂蛋白胆固醇升高可能会混淆血脂异常患者的管理策略。处方CM3-FA产品的心血管结局研究正在进行中。
OM3-FA膳食补充剂不应替代处方产品，且含DHA的处方OM3-FA产品与高纯度EPA（二十碳五烯酸乙酯）不等同或不可互换，不应被其替代。
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