US Food & Drug Administration recognises the role of EPA in cardiovascular health


Circulating triglyceride levels provide important information as a marker associated with the risk for heart disease and stroke.  Hypertriglyceridemia, a condition in which triglyceride levels are elevated,  is a risk factor for coronary artery disease.  If left untreated, coronary artery disease can lead to a heart attack; methods to safely reduce triglyceride levels are being sought.  With the role of dietary intervention gaining popularity as a safe method of restoring and maintaining health, it is encouraging that the U.S. Food and Drug Administration (FDA) has recently approved the use of ethyl-EPA as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (very high triglycerides of 500mg/dL or more).

Evidence for omega-3 in heart health

FDA approves pure EPA drug for triglyceride management in cardiovascular health

The consumption of oily fish as a protective factor against cardiovascular mortality stems from epidemiological observations of Greenland Eskimos.1 There have been numerous subsequent studies – epidemiological, observational and clinical – that have directly supported the concept that omega-3 plays a role in the prevention of coronary artery disease and cardiovascular disease.

How much omega-3 should we be consuming?

The amount of omega-3 fatty acids recommended has been determined by the government’s Scientific Advisory Committee on Nutrition which suggests eating a minimum of 450mg per day (3g per week) of long-chain omega-3 fatty acids.2 One portion of oily fish (such as herring, mackerel, trout, salmon, fresh tuna, sardines) is about 140g, and this alone can provide the minimum 3g of long-chain omega-3 fatty acids advised per week.   Information from national dietary surveys shows, however, that the national average is well below this.3     Whilst the benefits of increasing fish intake are increasingly clear, the UK population would need to maintain a considerable increase in fish consumption to achieve the recommended omega-3 levels..  It should, though, be borne in mind that such an increase may also affect dietary exposure levels to chemical contaminants, with an increased risk of exceeding those levels currently considered to be safe and acceptable; increasing fish intake may also not be a viable option for everyone.

EPA and the regulation of blood biomarkers

Certain blood biomarkers (risk factors for certain cardiovascular conditions, for example) such as c-reactive protein, cholesterol, inflammatory cytokines and triglycerides are indicators of general health status – these levels must be carefully regulated since levels which are too low or too high can have a detrimental effect on health. In terms of prevention, fish consumption is associated with healthier levels of these biomarkers, but if levels are excessively high in patients, the most effective way to regulate these blood biomarkers is via supplementation with highly concentrated and isolated EPA.  Ethyl-EPA supplements contain highly concentrated pure eicosapentaenoic acid – better known as one of the omega-3s from marine sources.

How much omega-3 is needed to treat cardiovascular disease?

It is suggested that at least 1.5 g/d long-chain omega-3 is required for demonstrable beneficial effects on cardiovascular risk factors such as platelet aggregation, plasma triacylglycerol levels, blood pressure and arrhythmias,2 and that doses of 2.5 – 3.4 long-chain omega-3 can exhibit even more pronounced cardiovascular benefits.3 Doses of 2-4g/day are required in some cases to reduce the pro-inflammatory eicosanoids and cytokines that exacerbate cardiovascular disease.4

What about generic fish oil?

EPA fish oil concentrates differ from conventional fish oils found on supermarket shelves because they contain only the active ingredient and at concentrations significantly higher than the concentration within generic brands.  Highly purified and highly concentrated, ethyl-EPA isolates offer a convenient and safe therapeutic intervention tool, both for the prevention and treatment of specific conditions that increase the risk of disease.   For example, 1.3g pure EPA can raise EPA levels in healthy individuals from 0.45% to 2.21%, with 2.7g raising levels to 3.36% in just 12 weeks.5

Is EPA is a medicine in the UK?

No, not yet.  In the UK, EPA is considered a food supplement and therefore is available in some health stores.  Whilst some food supplements and fish oils claim to be high in EPA they often do not contain the pure form of ethyl-EPA.   E-EPA 90 is the purest ethyl-EPA concentrate available without prescription.  Extracted from marine anchovy oil and ultra-purified using molecular distillation, E-EPA 90 provides 1g EPA with just two easy-to-swallow capsules daily, making it the ideal therapeutic oil for reducing cardiovascular risk factors.

References

1. Kromann, N. & Green, A. Epidemiological studies in the Upernavik district, Greenland. Incidence of some chronic diseases 1950-1974. Acta medica Scandinavica 208, 401-6 (1980).

2. SACN/COT (Scientific Advisory Committee on Nutrition/ Committee on Toxicity) (2004) Advice on Fish Consumption: Benefits and Risks. HMSO: London.

3. NDNS (National Diet and Nutrition Survey) 2012 http://www.defra.gov.uk/statistics/files/defra-stats-foodfarm-food-familyfood-2010-1112131.pdf

3. Harris, W.S. & Von Schacky, C. The Omega-3 Index: a new risk factor for death from coronary heart disease? Preventive medicine 39, 212-20 (2004).

4. Rupp, H. Omacor (prescription omega-3-acid ethyl esters 90): From severe rhythm disorders to hypertriglyceridemia. Advances in therapy 26, 675-90 (2009).

5. Mehra, M.R., Lavie, C.J., Ventura, H.O. & Milani, R.V. Fish oils produce anti-inflammatory effects and improve body weight in severe heart failure. The Journal of heart and lung transplantation: the official publication of the International Society for Heart Transplantation 25, 834-8 (2006).

6. Krul, E.S. et al. Effects of duration of treatment and dosage of eicosapentaenoic acid and stearidonic acid on red blood cell eicosapentaenoic acid content. Prostaglandins, leukotrienes, and essential fatty acids 86, 51-9 (2012).

 

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