Interest in omega-3 fatty acids have increased since publication of the results of REDUCE-IT.
Today’s prescription omega-3 fatty acid drugs effectively lower triglycerides, the American Heart Association (AHA) said today in an advisory report,1 which warned that patients should avoid treating themselves with fish oil supplements not approved by the FDA.
Prescription forms of omega-3 fatty acids can reduce triglyceride levels 20% to 30% for those who are diagnosed with high levels. Data from CDC show that about 25% of Americans have triglycerides above 150 mg/dL, which is above what is recommended;2 those with levels from 200 to 499 mg/dL are considered to have high triglycerides, and those with 500 mg/dL have very high triglycerides.
Triglycerides are fats that circulate in the bloodstream. Once triglycerides reach 200 mg/dL, patients are at risk of atherosclerosis (narrowing of the arteries), heart attacks, and strokes. Those with triglycerides above 500 mg/dL are also at risk of pancreatitis, an inflammation of the pancreas.
“From our review of the evidence from 17 randomized, controlled clinical trials on high triglyceride levels, we concluded that treatment with 4 grams daily of any of the available prescription choices is effective and can be used safely in conjunction with statin medicines that lower cholesterol,” said Ann Skulas-Ray, PhD, an author of the advisory published in AHA journal Circulation,1 said in a statement.
The advisory comes as evidence accumulates that a formulation of omega-3 fatty acid, icosapent ethyl, sold as Vascepa, offers benefits beyond lowering triglycerides. The medication, a highly purified eicosapentaenoic acid (EPA), has been shown to reduce the risk of heart attacks, strokes, and cardiovascular events by 25% among patients with elevated triglycerides when taken with a statin.3
FDA first approved Vascepa in 2012 to treat patients with high triglycerides. Amarin, which makes Vascepa, is seeking a cardiovascular indication for the medication from FDA. A decision had been expected in late September; however, FDA has now scheduled an advisory committee meeting for November 14, 2019, and a decision is not expected before December.
Highlights from today’s advisory include:
“Dietary supplements containing omega-3 fatty acids are not regulated by the FDA. They should not be used in place of prescription medication for the long-term management of high triglycerides,” said Skulas-Ray, who is an assistant professor in the Department of Nutritional Sciences at the University of Arizona in Tucson.
In an earlier advisory released in 2017, AHA said there was not enough evidence to support using omega-3 fatty acid supplements to prevent heart disease in the general population.
Interest in omega-3 fatty acids has increased with publication of results from REDUCE-IT, the study that identified Vascepa’s ability to reduce major cardiovascular events. REDUCE-IT was presented at the 2018 annual meeting of AHA, and additional results were presented at the 2019 meeting of the American College of Cardiology. The advisory notes that results from a trial involving a EPA + DHA medication are due in 2020.