The drug Vascepa has been approved by the Food and Drug Administration.
It aims to stop cardiovascular events.
Vascepa is fish oil based and designed to greatly help individuals with high triglyceride levels.
The Food and Drug Administration (FDA) approved utilization of a fish oil based drug called Vascepa to greatly help prevent cardiovascular events like heart attacks, strokes, and death in at-risk patients.
Vascepa, which will be produced by the drug manufacturer Amarin Pharma Inc., is the very first drug of its kind to greatly help cut cardiovascular risk in individuals with already high triglyceride levels, or elevated levels of fat in the blood.
Although the drug once was approved to take care of severe hypertriglyceridemia, or high triglycerides, the FDA is now expanding its use to lessen cardiovascular risk as well.
It’s built to be properly used along with statins — a commonly used kind of lipid lowering drugs — to further reduce one’s overall cardiovascular risk.
The ingredient in Vascepa is eicosapentaenoic acid, an omega-3 fatty acid derived from fish oil — however 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 requirement 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 gives patients with elevated triglycerides and other important risk factors, including cardiovascular disease, stroke, and diabetes, an adjunctive treatment option that could help decrease their risk of cardiovascular events.”
The drug significantly lowers cardiovascular risk and triglyceride levels
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 certainly were at least 50 years of age and had diabetes and other risk factors for heart disease.
The researchers unearthed that people who took Vascepa were much not as likely (by about 25 percent) to see 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 negative effects that took place. Some had an increased risk of atrial fibrillation, or an irregular heartbeat, requiring them to be hospitalized.
Others had an increased risk of bleeding events — especially people who have been 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.
The mechanism isn’t well understood
Although 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 aftereffects 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 could also have to do with the how omega-3 fatty acids connect to 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 in place of those commonly available and sold at vitamin stores,” Patel said.
All of the OTC supplements we see in stores haven’t been clinically proven and offer no known health benefit.
High triglycerides increase risk of stroke, death
It’s estimated that about 25 percentTrusted Source of U.S. adults ages 20 and older have high triglycerides — a condition associated with heart disease.
Elevated triglyceride levels cause plaque to build up in the arteries, which increases the chance for a coronary 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, individuals with a higher cardiovascular risk take statins, a drug that could help reduce one’s risk of heart attacks. But statins don’t always do the trick.
“Notice the chance reduction with statin therapy is not 100 percent. There are other contributing factors that cause cardiovascular events which cardiologists reference as residual risk. Triglycerides may be one,” Mintz said.
Vascepa is an essential addition to the cardiologist’s toolbox, Mintz said, as it can certainly help significantly reduce cardiovascular events in lots of people.
The underside line
The FDA approved utilization of a fish oil based drug, Vascepa, to greatly help prevent cardiovascular events like heart attacks, strokes, and death in at-risk patients.
Vascepa is the very first drug of its kind to greatly help cut cardiovascular risk in individuals with already high triglyceride levels. It is made to be properly used along with statins.
As millions of Americans have cardiovascular disease, the leading reason for death in the United States, health experts are optimistic about the new, expanded approval for Vascepa.