24 Dec New treatment available for heart disease
The Food and Drug Administration (FDA) has recently approved a drug derived from fish oil as an additional therapy for people at risk of experiencing cardiovascular events.
According to the Centers for Disease Control and Prevention (CDC), heart disease is the leading cause of death among adults in the United States. In fact, every 37 seconds, one person dies due to a cardiovascular event in the U.S.
For this reason, it is important to try to prevent poor cardiovascular outcomes in people at risk. Elevated triglyceride levels, which are a marker of blood lipids (fats), are one key risk factor to look out for.
Last week, the FDA issued a statement explaining that they had approved the use of a new drug as an additional therapy to help prevent cardiovascular disease in adults with triglyceride levels of 150 milligrams per deciliter or higher, which count as elevated levels.
The drug, Vascepa, comes in capsule form. Its main active ingredient is eicosapentaenoic acid. This is an omega-3 fatty acid extracted from fish oil.
As per the FDA recommendations, doctors should only prescribe Vascepa to those with abnormally high triglyceride levels and as an additional therapy to the maximum tolerated dosage of statins. These are the drugs that people usually take to keep their cholesterol levels in check and minimize cardiovascular risk.
“The FDA recognizes that there is a need for additional medical treatments for cardiovascular disease,” says 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.
“This approval will give [people] 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.”
According to its manufacturers, Vascepa can lower blood triglyceride levels by around 33%.
The researchers who conducted the clinical trial did, however, note that the drug was sometimes associated with an increased risk of heart problems — specifically atrial fibrillation or atrial flutter — that called for hospitalization. However, this risk was more pronounced in people who already had a history of these two conditions.
Another potential side effect is a higher risk of bleeding — though, again, this is more likely to occur in people already taking other drugs associated with a higher risk of bleeding events, such as aspirin, clopidogrel, or warfarin.
Finally, they warn that people with known allergies to fish or shellfish may experience allergic reactions to this drug and that they should only take it as advised by their doctor and discontinue the treatment if they do experience any symptoms of an allergic reaction.