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 personally take Vascepa off label because of it's anti-inflammatory effects as proven by the significant reduction in hs-CRP in clinical trials. The correlation between inflammation and CVD is well established the the medical literature. In my opinion, it would be a travesty to not allow Vascepa to be marketed for the ANCHOR indication of TG's >200 until after the results of the REDUCE-IT trial. Real people's lives and health are at stake here, not just numbers. Many people will benefit from this drug. Thank you.

Terence Gallagher
Haverford, Pennsylvania
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