School of Pharmacy and Health Professions, Creighton University, Omaha, NE, USA.
Medical University of South Carolina, Charleston, SC, USA.
Adv Ther. 2020 Feb;37(2):656-670. doi: 10.1007/s12325-019-01211-1. Epub 2020 Jan 9.
Currently available omega-3 (OM-3) fatty acid products in the US are either nonprescription dietary supplements (e.g., fish oils) or prescription (Rx) medications. As such, we aimed to describe critical therapeutic differences among the OM-3 fatty acids, focusing on differences between fish oil supplements and Rx OM-3s.
A narrative review of known papers salient to this topic was conducted.
Despite the multiple purported clinical benefits, the published evidence for OM-3 dietary supplements is generally insufficient, inconsistent, or negative. Rx OM-3 products are indicated as an adjunct to diet to reduce triglycerides (TG) in adults with severe hypertriglyceridemia (TG ≥ 500 mg/dl). Recently, the Rx eicosapentaenoic acid (EPA)-only OM-3, icosapent ethyl, demonstrated cardiovascular (CV) risk reduction among statin-treated patients at high risk of CV disease in a large CV outcomes trial (CVOT), and is now also indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated TG (≥ 150 mg/dL) and established CVD or diabetes mellitus and ≥ 2 additional risk factors for CVD. In contrast to the rigorous regulatory standards for safety, efficacy, and manufacturing of medications (whether Rx or over the counter), the Food and Drug Administration manages dietary supplements as food. Issues specific to OM-3 dietary supplements include variable content, labeling inconsistencies, and poor product quality/impurity. Given these issues, OM-3 dietary supplements should not be substituted for Rx OM-3 products. The efficacy of the EPA-only Rx OM-3 product in a large CVOT cannot be extrapolated to other OM-3 products.
Consumers and health care providers need to recognize critical differences between Rx and OM-3 dietary supplements to ensure appropriate use of each OM-3 product.
目前美国市场上可获得的ω-3（OM-3）脂肪酸产品要么是非处方膳食补充剂（如鱼油），要么是处方（Rx）药物。因此，我们旨在描述 OM-3 脂肪酸之间的关键治疗差异，重点关注鱼油补充剂和 Rx OM-3 之间的差异。
对与本主题相关的已知论文进行了叙述性综述。
尽管有多种据称的临床益处，但 OM-3 膳食补充剂的已发表证据通常不足、不一致或为负面。Rx OM-3 产品被指示作为饮食的辅助手段，以降低严重高甘油三酯血症（TG≥500mg/dl）成人的甘油三酯（TG）。最近，Rx 二十碳五烯酸（EPA）-仅 OM-3，二十碳五烯酸乙酯，在一项大型心血管结局试验（CVOT）中，在他汀类药物治疗的高心血管疾病风险患者中显示出心血管（CV）风险降低，现在也被指示作为最大耐受他汀类药物治疗的辅助手段，以降低升高的甘油三酯（≥150mg/dL）和已确诊的心血管疾病或糖尿病且有≥2 个心血管疾病危险因素的成年患者的心肌梗死、中风、冠状动脉血运重建和需要住院治疗的不稳定型心绞痛的风险。与药物（无论是 Rx 还是非处方）的安全性、有效性和制造的严格监管标准相比，食品和药物管理局将膳食补充剂作为食品进行管理。OM-3 膳食补充剂的具体问题包括含量变化、标签不一致和产品质量/杂质差。鉴于这些问题，OM-3 膳食补充剂不应替代 Rx OM-3 产品。大型 CVOT 中 EPA 仅 Rx OM-3 产品的疗效不能外推至其他 OM-3 产品。
消费者和医疗保健提供者需要认识到 Rx 和 OM-3 膳食补充剂之间的关键差异，以确保每种 OM-3 产品的正确使用。
