Prescribed, Pure Omega-3 Fish Oil to Help More Adults with Heart Attack, Stroke Risks

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. However, these prescribed large doses of EPA are not associated with the popular supplements marketed as “fish oils containing omega-3″ — and everyone should check with their doctor before taking any supplements.

In November, 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, which contains “icosapent ethyl,” a highly purified type of omega-3 fatty acid, 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. The FDA panel’s go-ahead allows the drug to 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.

Now, new findings from a landmark clinical study has found that icosapent ethyl (Vascepa) significantly reduced first and subsequent revascularizations (surgical procedures to restore blood flow), compared with placebo, in statin-treated patients with elevated triglycerides and increased cardiovascular risk.

A lead author of the study’s findings, Benjamin Peterson, M.D, interventional cardiology fellow at Brigham and Women’s Hospital Heart & Vascular Center and Harvard Medical School, said: “Overall, there was a 34 percent reduction in first revascularization events, and even higher reductions in subsequent revascularization events among statin-stabilized patients treated with icosapent ethyl (Vascepa) versus placebo. There was also a significant 32 percent reduction in stenting and a 39 percent reduction in the need for coronary artery bypass grafting (CABG) …”

The number of Americans eligible for prescribed high doses of purified EPA 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.