In 2019, the FDA sought the advice of an expert panel to review new data about a fish oil drug. By a vote of 16-0, the panel recommended that the FDA allow broader claims about its ability to reduce cardiovascular risks. In December 2019, the FDA acted on this recommendation by expanding the “approved use” of this fish oil drug to reducing risk of heart attack, stroke, and death in high-risk patients.1
This decision was largely based on a study published in the New England Journal of Medicine showing remarkable benefits in people taking high doses of a fish oil drug that consisted of the EPA omega-3 fraction.2
Compared with placebo, there was a 25% reduction in a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary stents/bypass surgeries, or unstable angina in the fish oil drug group.
The study observed several other benefits including:
Cardiovascular death reduced by 20%
Fatal or nonfatal heart attacks reduced by 31%
Fatal or nonfatal stroke reduced by 28%
Urgent or emergency coronary revascularization reduced by 35%
Hospitalization for unstable angina reduced by 32%
This fish oil is marketed to doctors as a drug that lowers triglycerides without raising LDL cholesterol.3 However, it is noteworthy that patients taking the EPA-only fish oil drug (Vascepa®) are unlikely to take other fish oil supplements. This ignores the critical role of the DHA component of the omega-3 family on life-sustaining processes, especially brain and eye health.
The estimated out-of-pocket cost, assuming no insurance coverage, is over $300 a month for this EPA-only fish oil drug. This is about seven times higher than what a comparable amount of EPA+DHA can be obtained for when using dietary supplements.
Is A Consensus Being Reached?
Results from recent, large studies continue to validate the need for higher-dose omega-3 intake. 1,000 mg a day of an EPA/DHA supplement (and only 2,000 IU/day of vitamin D) yields meaningful risk reduction in several subgroups including:17,21
25% reduction in cancer deaths in the vitamin D group when the first two years of follow-up were excluded,
28% reduction in heart attack risk, and 50% reduction in fatal heart attack risk, in the fish oil group, and
22% reduction in angioplasty procedures (opening a narrowed coronary blood vessel, often with a stent) in the fish oil group.
At the American Heart Association annual meeting in November 2019, a presentation on a study that administered about 3,300 mg of an EPA/DHA fish oil drug called Lovaza® revealed striking improvements in cognitive functions in older individuals.22
What made this study so compelling is that blood levels of EPA/DHA were carefully measured. The cognitive benefits occurred in those with an omega-3 index over 4%. Here is the conclusion from this presentation made at the American Heart Association meeting:22
“High dose EPA and DHA prevented cognitive decline in cognitively healthy coronary artery disease subjects, with younger subjects, nondiabetic subjects, and those achieving an omega-3 fatty acid index ≥4% having greatest benefit. These findings are especially important for coronary artery disease patients as coronary artery disease is a risk factor for dementia.”
What I continue to observe in the published data is consensus that higher-dose omega-3 intake is what induces meaningful risk-reduction benefits.
Overlooked Role of Dietary Omega-3s
No one argues with the idea that eating two to three cold-water fish meals a week reduces cardiovascular and other disease risks. This is nearly universally agreed upon and accepted, including in the medical profession and among researchers.
Yet missing from virtually all research on fish oil supplements is each study subject’s dietary intake of EPA/DHA-rich foods.
To put this into perspective, a 4-ounce can of wild salmon contains about 2,000 mg of total omega-3s providing about 1,800 mg of EPA/DHA.
So, a clinical trial using only 1,000 mg of supplemental EPA/DHA in people who regularly consume canned wild salmon might yield benefits because the total daily consumption of EPA+DHA is around 2,800 mg.
On the flip side, individuals consuming typical Western dietary patterns that are nearly devoid of omega-3s may require far higher amounts of supplemental EPA/DHA (3,300 mg to 4,000 mg) to achieve the same results.
The significance of these differences cannot be overstated, both from a public health standpoint and on huge savings on fish oil drugs and supplements. People whose diets already provide ample quantities of EPA/DHA will likely require lower potencies of fish oil drugs or supplements.
Yet a one-size-fits-all approach is the current protocol. The FDA now allows certain high-risk patients to be prescribed a 4,000 mg/day potency of an expensive EPA-only drug—but advises against the same potencies of lower-cost fish oil supplements!
How This Impacts You
The importance of achieving optimal EPA/DHA status cannot be overstated. It impacts a person’s risk of multitudes of disorders, many that are life threatening.
You should consume omega-3s in your diet by eating cold-water fish meals and/or via plant sources like walnuts, flax, and other foods.
People with stubbornly high triglyceride levels are advised to increase their fish oil intake to target a triglyceride blood level below 100 mg/dL.
Too Many Needless Heart Attacks
Growing consensus about fish oil, along with the new claims allowed by the FDA, will help enable more Americans to benefit from higher consumption of omega-3 fatty acids.
The tragedy is that it took so long for the benefits of omega-3s to be widely recognized.
Cardiovascular disease remains the leading cause of disability and death in the United States, especially in elderly population groups.
Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-use-drug-reduce-risk-cardiovascular-events-certain-adult-patient-groups. Accessed March 13, 2020.
Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019 Jan 3;380(1):11-22.
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Available at: https://ods.od.nih.gov/factsheets/Omega3FattyAcids-HealthProfessional/. Accessed March 18, 2020.
Jimenez-Gomez Y, Marin C, Peerez-Martinez P, et al. A low-fat, high-complex carbohydrate diet supplemented with long-chain (n-3) fatty acids alters the postprandial lipoprotein profile in patients with metabolic syndrome. J Nutr. 2010 Sep;140(9):1595-601.
Skulas-Ray AC, Wilson PWF, Harris WS, et al. Omega-3 Fatty Acids for the Management of Hypertriglyceridemia: A Science Advisory From the American Heart Association. Circulation. 2019 Sep 17;140(12):e673-e91.
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Siscovick DS, Barringer TA, Fretts AM, et al. Omega-3 Polyunsaturated Fatty Acid (Fish Oil) Supplementation and the Prevention of Clinical Cardiovascular Disease: A Science Advisory From the American Heart Association. Circulation. 2017 Apr 11;135(15):e867-e84.
Aung T, Halsey J, Kromhout D, et al. Associations of Omega-3 Fatty Acid Supplement Use With Cardiovascular Disease Risks: Meta-analysis of 10 Trials Involving 77917 Individuals. JAMA Cardiol. 2018 Mar 1;3(3):225-34.
Manson JE, Cook NR, Lee IM, et al. Marine n-3 Fatty Acids and Prevention of Cardiovascular Disease and Cancer. N Engl J Med. 2019 Jan 3;380(1):23-32.
Group ASC, Bowman L, Mafham M, et al. Effects of n-3 Fatty Acid Supplements in Diabetes Mellitus. N Engl J Med. 2018 Oct 18;379(16):1540-50.
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Vemuri B, Malik A, Asbeutah AAA, et al. Abstract 10723: A Plasma Phospholipid Omega-3 Fatty Acid Index > 4% Prevents Cognitive Decline in Cognitively Healthy Subjects With Coronary Artery Disease. Circulation. 2019;140(Suppl_1):A10723-A.
Adapted from: https://www.lifeextension.com/magazine/2020/8/are-we-reaching-consensus-about-fish-oil