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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To all who are currently taking medications to reduce their risk of a heart attack.

Because of inherited lipid disorders, and a family history of heart attacks, I have been on maximum dose Statin drugs since 1985. Over the past twenty years I have also been prescribed Fibrates, Niacin and Zetia. All of these drugs have side effects... some worse than others. Now we have Vascepa. Vascepa is by far the most patient friendly, easiest drug I have ever taken to improve my lipid profile and hopefully reduce my risk of a heart attack.

Recent Clinical Outcome trial results have shown that Fibrates and Niacin may not be effective in reducing risk and I no longer take these drugs. Zetia is currently being studied in an Outcome trial and results are due late 2014. I continue to take Zetia while I await the trial results. We will not know how effective Vascepa is until we get a look at the interim trial data, possibly in late 2015, however, I believe that all those at risk should take Vascepa until we know. Earlier trials ( JELIS Study ) demonstrated benefit using a very similar drug ( Epadel ). Vascepa is a very safe drug with none of the muscle cramping of Statin drugs, the stomach upsets of the Fibrates, the flushing of Niacin or the fishy burps of Lovaza.

I strongly recommend that anyone "at risk" talk to their MD about a prescription for it.

Gary Head
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