The National Lipid Association has issued a position statement recommending the use of icosapent ethyl for treating patients with atherosclerotic CVD (ASCVD) or type 2 diabetes, rooting its endorsement in the positive results of the REDUCE-IT study.
REDUCE-IT studied the role of icosapent ethyl—sold by Amarin commercially as Vascepa—in reducing major adverse cardiovascular events (MACE) in patients with diabetes and ASCVD and was first presented at ACC.18. The trial revealed a 25% reduction in MACE with the drug, which was first developed to lower cardiovascular risk in patients who remained at a high risk for heart disease despite taking a statin.
The NLA’s latest recommendation was issued as a Class I, Level B-R recommendation—the highest possible. And it’s not alone in its certainty, joining the American Diabetes Association in promoting icosapent ethyl as a CVD risk reduction tool for patients with both diabetes and ASCVD. In March of this year, the ADA issued updates to its Standard of Medical Care in Diabetes guidelines recommending the drug for patients whose triglyceride levels persisted between 135 mg/dL and 499 mg/dL despite statin therapy.
Specifically, the NLA is recommending icosapent ethyl for ASCVD risk reduction in high- and very-high-risk patients who are either 45 years old and up with clinical ASCVD or 50 years old and up with type 2 diabetes, fasting triglycerides between 135-499 mg/dL and at least one additional risk factor. In patients with type 2 diabetes, the medication is recommended only if the patient is already taking a maximally tolerated statin, with or without ezetimibe.
“The NLA has a long history in the atherosclerotic cardiovascular disease risk and triglyceride space,” Antonio M. Gotto, Jr., MD, DPhil, said in a statement issued by Amarin. “REDUCE-IT is an important contribution to our understanding of the use of omega-3 fatty acids in ASCVD risk reduction. The NLA has reviewed the existing data between ASCVD, hypertriglyceridemic patients and high-dose omega-3 fatty acids and recommends the use of icosapent ethyl in appropriate high- and very-high-risk patients.”
Icosapent ethyl is currently approved by the FDA as Vascepa, indicated as an adjunct to diet to reduce triglyceride levels in adults with severe (500 mg/dL and up) hypertriglyceridemia. Amarin has submitted a supplemental new drug application to expand the drug’s label based on the REDUCE-IT results, and the FDA is expected to act on that request by Dec. 28.
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