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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Two years ago I suffered a heart attack as a result of two blocked arteries that required stents. In addition to the routine heart medication I was placed on a high dose statin 80mg. With the statin, I felt like I was in a fog and had this persistent muscle ache in my arms and legs. My Cardiologist said my symptoms were common side effects and tested for the muscle wasting syndrome that can happen with statins. My tests came back negative and the goal was a change in lifestyle to reduce the size of the statin dose. My doctor suggested I add COQ-10 and fish oil. After checking with consumer reports I found many of the affordable (inexpensive) brands had contaminants. I tried Plusepa then Krill oil to lower my triglycerides and ease the muscle pain I have by taking atorvastatin. I also tried OTC Niacin at 750mg and COQ-10 and all I was able to gain was a case of reflux. I stopped taking all the supplements and the reflux went away but not the dull ache from the statin. During this time I was able to get the dose of the statin down to 20 mg through diet and my goal was to keep my LDL under 79 and my triglycerides under 90. I was not able to exercise which was my next goal because of the ache from the statins. Then I heard about Vascepa. After educating my cardiologist he gave me a prescription for 2g and I started this drug in June 2013. Within 3 weeks I was virtually ache free and could lift weights and I am now working out 3 days and sometimes 5 days per week. Pain free and my entire cholesterol profile is down on average 9% since my last test and down compared to a year's worth of tests. My Cardiologist let me know that if my test results remain the same on my next visit, he will lower my statin dose to the lowest level. It has taken over 2 years to get there and adding Vascepa did the trick. To add, I have not experienced any side effects, bloating, reflux or any pain or discomfort from taking Vascepa.

Mark Zarcone
Columbia, MD
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