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 an academic center based clinician who specializes in nutrition and treatment of obesity related complications. With the current epidemic of obesity in the US, CVD remains the top cause mortality in the US. Although statins have had an important impact in lowering cholesterol levels and improving CV health, an important clinical problem that persists is the elevated triglyceride levels in patients that already been optimally treated with statins. Moreover, many patients in our clinical practice do not tolerate statins well due to number of its well known adverse effects.

For those patients with continued elevations of triglycerides and at high risk for CVD with multiple pre-existing risk factors, lowering their triglyceride level is an important component of managing their CVD risk and is recommended by most major medical societies. It is the standard of care in most physicians' practice to lower elevated triglycerides in high risk patients that have persistent elevations in triglycerides. Based on the published data, vascepa has excellent efficacy and safety profile to be used safely and effectively to lower triglyceride level. Given the overwhelming data indicating a correlation between elevated triglyceride and increased risk of CVD and the current standard of care recommendations to lower triglyceride levels in high risk patients, a drug such as vascepa that lowers triglyceride without increasing LDL cholesterol and excellent safety profile would be an important adjunct to statins in managing cardiovascular risk.

Delaying the approval of vascepa until outcome study would deny this important adjunctive therapy to those patients at greatest risk to develop CVD complications. In essence, FDA would be publicly advocating against the treatment of elevated triglycerides in patients with high risk of developing CVD. This would certainly be counter to current guidelines and recommended standard of care. Given the current medical recommendations and standard of care practice, I ask that you approve vascepa for this important class of patients to treat high levels of triglycerides. A decision against vascepa approval for lowering elevated triglycerides would be counter to current medical recommendations and would deprive this high risk population of important potentially life saving therapeutic agent.

Michael Henderson
Southampton, Pennsylvania
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