FDA approves wider use of drug for heart patients with high cholesterol and other risks

Published: Dec. 18, 2019 at 6:23 PM CST
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The drug is called Vascepa (icosapent ethyl), and it's geared toward adults with high risk of heart attacks due to bad cholesterol and other contributors like smoking, high blood pressure, obesity, and diabetes.

A recent scientific study presented to the American Heart Association showed that over five years in tests of more than 8,000 patients with heart disease and other high risk factors, the fish-oil based Vascepa lowered their risk of heart complications by 25 percent and the risk of death by 20 percent.

"The way they determine reduced risk like that is by comparing it to a placebo group," explained Terry Barks, a pharmacy specialist with Mercy. "So over the years they look at the incidents of outcomes in the placebo group versus the treated group."

According to a release by the Food and Drug Administration, Vascepa is the first FDA-approved drug to reduce cardiovascular risk among patients with elevated triglyceride levels as an add-on to maximally tolerated statin therapy. Statins are drugs used to treat elevated cholesterol levels and reduce the risk of cardiovascular events.

“The FDA recognizes there is a need for additional medical treatments for cardiovascular disease,” said John Sharretts, M.D., acting deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval will give patients with elevated triglycerides and other important risk factors, including heart disease, stroke and diabetes, an adjunctive treatment option that can help decrease their risk of cardiovascular events.”

High levels of triglycerides can play a role in the hardening of arteries or thickening of the artery wall, which can increase the risk of a heart attack or stroke. However, the mechanisms of action that contribute to reduced cardiovascular events among patients taking Vascepa are not completely understood.

Like all drugs Vascepa does have possible side effects including joint pain and swelling of the hands and legs. But the FDA's approval for wider use is being heralded as a major step in cholesterol-related medicine where the most common drugs are statin-related like Lipitor.

"I think it's the biggest development in cardiovascular prevention since statins were introduced," said Dr. Deepak Bhatt, a cardiovascular specialist from the Brigham and Women's Hospital in Boston. "But beyond that it will spawn a whole line of scientific research trying to figure out how this drug will work."

The new drug is significant because every 43 seconds someone in the U.S. is having a heart attack and nearly 95 million Americans have high cholesterol. The average age of a heart attack victim is actually going down in recent years from 64 to 60.

Of course there are already fish-oil based products available without a prescription. So what's the difference between them and Vascepa?

"The counter products simply do not reduce the adverse outcomes of a heart attack and stroke," Barks said. "Although they do lower triglycerides."

So who should consider looking into the drug?

"If you have cardiovascular disease with elevated triglyceride levels, have at least two of the risk factors (smoking, obesity, high blood pressure, diabetes) and are on a maximum dose of a statin, you need to discuss adding Vascepa to your regime with your doctor," Barks said.