Which prescription fish oil products are approved by the FDA for the treatment of hypertriglyceridemia (high triglyceride levels)?

Updated: Jul 23, 2021
  • Author: Mary Ellen T Sweeney, MD; Chief Editor: Romesh Khardori, MD, PhD, FACP  more...
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Several prescription fish oil products have been approved by the FDA for triglyceride levels exceeding 500 mg/dL. One example is Lovaza. One 1-g capsule contains approximately 465 mg of EPA and 375 mg of DHA. Like the fibrates, high-dose Lovaza and other DHA-containing prescription omega-3 products increase LDL-C levels, particularly when triglyceride levels are greater than 400 mg/dL. The impact on HDL-C levels varies; levels may modestly increase or remain unchanged. Another prescription omega-3 fatty acid product, Omtryg, was approved by the FDA in 2014 and contains EPA and DHA in the same amounts as Lovaza. [81]

A third prescription fish oil is an ultra-pure omega fatty acid that contains an ethyl ester of EPA, icosapent ethyl (Vascepa). Each 1-g icosapent capsule contains at least 96% EPA and no DHA. Past studies suggest that highly purified EPA may lower TG levels without increasing LDL cholesterol levels. [78, 79] TG-lowering therapies (eg, fibrates, fish oils containing both EPA and DHA) can substantially increase LDL cholesterol levels in patients with severe hypertriglyceridemia (≥500 mg/dL).

The Multi-center, plAcebo-controlled, Randomized, double-blINd, 12-week study with an open-label Extension [MARINE] trial randomized 229 diet-stable patients with fasting TG levels from 500-2000 mg/dL (with or without background statin therapy) to icosapent 4 g/day, icosapent 2 g/day, or placebo. Results showed that icosapent significantly reduced the TG levels and improved other lipid parameters without significantly increasing the LDL cholesterol levels. Icosapent 4 g/day reduced the placebo-corrected TG levels by 33.1% (n = 76; P< 0.0001) and icosapent 2 g/day by 19.7% (n = 73; P = 0.0051). For a baseline TG level >750 mg/dL, icosapent 4 g/day reduced the placebo-corrected TG levels by 45.4% (n = 28; P = 0.0001) and icosapent 2 g/day by 32.9% (n = 28; P = 0.0016). [82]

Vascazen, a medical food derived from fish oil, is also available. Each 1-g Vascazen capsule contains at least 900 mg of ethyl esters of omega-3 fatty acids sourced from fish oils and includes approximately 680 mg of EPA and approximately 110 mg of DHA.

Note that although fatty fish (eg, salmon, tuna, trout, mackerel, sardines) are good sources of omega-3 fatty acids, they also usually contain high concentrations of mercury and polychlorinated biphenyls (PCBs). Fish oil supplements that can be obtained without a prescription have negligible amounts of mercury. [90] The advantage of prescription fish oil is that fewer capsules are necessary to achieve a therapeutic dose, facilitating adherence. Additionally, the prescription products have been thoroughly tested in phase 3 trials to show safety and efficacy (particularly for lowering very high TGs). [82, 84] Consistency of potency is ensured with the prescription fish oil products.

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