November 15, 2019 — A panel of experts unanimously recommended Thursday that the Food and Drug Administration allow wider use of a fish oil-based drug to treat people at high risk for heart attacks and strokes even when they are taking cholesterol-lowering drugs.
“There’s a definite need for additional therapeutic approaches,” said Kenneth D. Burman, chief of the endocrine section at MedStar Washington Hospital Center, who chaired the panel. Despite some side effects, he said, “this seems a very useful new agent for addition to the armamentarium for the treatment of these patients.”
The drug, a purified version of the Omega-3 fatty acid found in fish, is aimed at some of the more than 40 million people in the U.S. who take statins to control their LDL, or “bad” cholesterol, and have adopted lifestyle changes, yet remain at risk of cardiovascular problems because of elevated triglyceride levels.
Triglycerides are another type of fat in the blood. When their levels are too high, generally more than 200 milligrams per deciliter of blood, the result can be deaths, heart attacks, strokes, unstable angina or the need for cardiac surgery.
A landmark 2018 study, led by a researcher at Brigham and Women’s Hospital and sponsored by Amarin, showed that patients who took four grams of Vascepa daily fared 25 percent better in staving off those events than those given a placebo. The researchers spent more than six years following more than 8,000 middle-aged and older patients in 11 countries who had coronary artery disease or diabetes and at least one other risk factor, such as high blood pressure.