Drug Initiative

Is the FDA ignoring heart risks from high triglycerides in the face of mounting evidence to the contrary?

The lives of millions of Americans are potentially at risk.

The EPA Drug Initiative (EPADI) urges the FDA to thoughtfully consider new and almost irrefutable proof that high triglycerides are a significant risk factor contributing to cardiovascular disease-related death and morbidity.

Recently, two independent studies were published in the prestigious New England Journal of Medicine (NEJM), both drawing the same conclusion: that reducing serum triglycerides to accepted, safe levels resulted in a 40% decrease in cardiovascular risk. These trial results are being universally hailed as groundbreaking, as they focus on people having a certain gene mutation, which elegantly eliminates all cardiovascular disease risk factors other than serum triglyceride levels. Both studies—from well-respected researchers—have caught the attention of the world, with the results being published by prominent news media including the New York Times and Forbes.

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I am a registered dietitian who is very dissapointed that Vascepa has not been approved for mixed dyslipidemia. Studies show that a lower serum EPA/AA ratio is significantly associated with an increased risk of coronary heart disease. No association was observed for DHA/AA ratio. Vascepa is an omega-3 agent containing 96% EPA. The current American diet is high in simple, highly-processed carbohydrates and omega-6 oils; consumption of omega-3 fatty acids is poor and represents only approximately 200mg per day of both EPA and DHA combined. Completed studies of Vascepa at 2 and 4 gram doses showed significant reductions in triglycerides, non-HDL-C, LDL-C, ApoB, LDL particle concentration, Lp-PLA2, hsCRP, ApoC, and cholesterol....all of which are considered risk factors in cardiac disease. The JELIS study, which observed 18,645 Japanese men and women, showed a major coronary event reduction of 19% when a drug similar to Vascepa was administered, 53% reduction in a sub-group of those with the highest risk. The mixed dyslipidema market is estimated at approximately 36 million Americans. Failure to approve Vascepa for this group would unnecessarily put many lives at risk. I humbly ask the FDA to approve Vascepa for this indication to help the fight against heart disease.

Tom Hitchcock
Endicott, NY
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