- The drug Vascepa has been approved by the Food and Drug Administration.
- It aims to prevent cardiovascular events.
- Vascepa is fish oil based and designed to help people with high triglyceride levels.
The Food and Drug Administration (FDA) approved use of a fish oil based drug called Vascepa to help prevent cardiovascular events like heart attacks, strokes, and death in at-risk patients.
Vascepa, which is produced by the drug manufacturer Amarin Pharma Inc., is the first drug of its kind to help cut cardiovascular risk in people with already high triglyceride levels, or elevated amounts of fat in the blood.
Though the drug was previously approved to treat severe hypertriglyceridemia, or high triglycerides, the FDA is now expanding its use to lower cardiovascular risk as well.
It’s designed to be used in conjunction with statins — a commonly used type of lipid lowering drugs — to further reduce one’s overall cardiovascular risk.
The active ingredient in Vascepa is eicosapentaenoic acid, an omega-3 fatty acid derived from fish oil — but the mechanisms behind Vascepa are not entirely understood.
In clinical trials, Vascepa significantly lowered people’s cardiovascular risk and triglyceride levels.
“The FDA recognizes there is a need for additional medical treatments for cardiovascular disease,” Dr. John Sharretts, the acting deputy director of the division of metabolism and endocrinology products in the FDA’s Center for Drug Evaluation and Research, stated in the FDA’s announcement. “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.”
The safety and efficacy of Vascepa was evaluated in a clinical study of 8,179 people age 45 and older.
All participants had a history of coronary artery, cerebrovascular, carotid artery, and peripheral artery disease — or they were at least 50 years old and had diabetes or other risk factors for heart disease.
The researchers found that those who took Vascepa were much less likely (by about 25 percent) to experience a cardiovascular event such as a stroke or heart attack.
Additionally, people’s triglyceride levels dropped by nearly 18 percent.
There were a couple adverse side effects that took place. Some had a higher risk of atrial fibrillation, or an irregular heartbeat, requiring them to be hospitalized.
Others had a higher risk of bleeding events — especially people who were taking medications (like aspirin or warfarin) that increase their risk of bleeding.
Most commonly, however, people experienced musculoskeletal pain, swelling of legs and hands, and arthralgia, or joint pain.
Though the mechanism of Vascepa isn’t well understood, some health experts suspect it may have to do with the drug’s anti-inflammatory effects.
“One mechanism of action may be the anti-inflammatory effects of the icosapent ethyl (Vascepa). Slowing the progression of cholesterol buildup in the arteries may be another mechanism,” Dr. Guy Mintz, the director of cardiovascular health and lipidology of cardiology at Northwell Health’s Sandra Atlas Bass Heart Hospital in New York.
It may also have to do with the how omega-3 fatty acids interact with the liver.
“Fish oil has omega-3 fatty acids that are beneficial fats and help reduce liver production of triglycerides,” Dr. Sanjiv Patel, a cardiologist at MemorialCare Heart & Vascular Institute at Orange Coast Medical Center in California.
Though Vascepa is fish oil based, it’s worth noting that over-the-counter (OTC) fish oil supplements do not share these same benefits.
“Drugs like Vacepa and Lovaza have higher concentrations of fish oil as opposed to those commonly available and sold at vitamin stores,” Patel said.
Most of the OTC supplements we see in stores have not been clinically proven and offer no known health benefit.
It’s estimated that about
Elevated triglyceride levels cause plaque to build up in the arteries, which increases the risk for a heart attack, stroke, and cardiovascular death.
A healthy triglyceride range is 150 milligrams per deciliter or less, but 25.1 percent of U.S. adults ages 20 and older have 150 mg/dL or more.
Typically, people with a high cardiovascular risk take statins, a drug that can greatly reduce one’s risk of heart attacks. But statins don’t always do the trick.
“Notice the risk reduction with statin therapy is not 100 percent. There are other contributing factors that cause cardiovascular events which cardiologists refer to as residual risk. Triglycerides may be one of them,” Mintz said.
Vascepa is an important addition to the cardiologist’s toolbox, Mintz said, as it can help significantly reduce cardiovascular events in many people.
The FDA approved use of a fish oil based drug, Vascepa, to help prevent cardiovascular events like heart attacks, strokes, and death in at-risk patients.
Vascepa is the first drug of its kind to help cut cardiovascular risk in people with already high triglyceride levels. It is designed to be used in conjunction with statins.
As millions of Americans have heart disease, the leading cause of death in the United States, health experts are optimistic about the new, expanded approval for Vascepa.