There is mounting evidence that prescribing high doses of purified EPA, an omega-3 fatty acid found in fish oil, can prevent heart attacks and strokes in some at-risk patients, according to U.S. regulators.
This month, an advisory panel to the U.S. Food and Drug Administration (FDA) voted unanimously to approve expanded use of the prescription drug, Vascepa, which is made from one type of omega-3 fatty acid, called eicosapentaenoic acid, or EPA.
Vascepa is already approved for use in people with very high levels of triglycerides, a type of fat in the blood which is measured in a standard cholesterol blood screening. With the FDA panel’s initial go-ahead, the drug may soon be approved for a much wider classification of U.S. adults — those who have had a heart attack or stroke, as well as those who have type 2 diabetes and an additional heart disease risk factor, including high blood pressure.
The number of Americans eligible for treatment could be in the millions because of the prevalence of diabetes and other risk factors.
Drug treatment involving large doses of prescription EPA has no relation to popular supplements marketed as “fish oils containing omega-3,” emphasizes Jonathan Fialkow, M.D. , deputy medical director, chief of cardiology and a certified lipid specialist at Miami Cardiac & Vascular Institute .
“After decades of decline, the number of deaths from cardiovascular disease has increased over the past few years,” said Dr. Fialkow. “Some believe this is due to lack of any new ‘gangbuster’ interventions. This medication , given to the right people, may be a new weapon in our arsenal to decrease cardiac events and death in the future and the FDA review supports this.”
The Lipid Management Program  at Miami Cardiac & Vascular Institute is part of a growing trend nationally to improve oversight and treatment of individuals who have not responded to initial therapies to combat their dyslipidemia, the term referring to an abnormal amount of lipids (triglycerides, cholesterol and/or fat phospholipids) in the blood.
Despite claims of improving heart health, over-the-counter dietary supplements promoted extensively as helping lower cholesterol levels are ineffective for the prevention of heart disease, many studies have found. The amount of fish oil in the daily recommended dose of Vascepa is the equivalent of eating about 8 to 10 servings of salmon a day.
The FDA panel’s approval followed published findings from a clinical trial involving Vascepa. Researchers concluded that adults treated with statins to control cholesterol levels — but still had high levels of triglycerides — had a 25 percent reduction in their relative risk of heart attacks, strokes and other cardiac events after being prescribed high doses of the purified EPA.
The study enrolled 8,179 adults and followed them, on average, for about five years. It was the first of its kind and marked an important milestone in the use of prescribed omega-3s, says Dr. Fialkow. The trial found that Vascepa, manufactured by Amarin, was safe.