The Food and Drug Administration (FDA) have recently approved a drug derived from fish oil as an adjuvant therapy for people at risk of experiencing cardiovascular events.
According to the Centers for Disease Control and Prevention (CDC), heart disease is
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
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 [recognize 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.”
Dr. John Sharretts
When triglyceride levels in the blood become too high, it can contribute to the thickening and stiffening of the artery walls. This increases a person’s risk of experiencing a cardiovascular event, such as a stroke or heart attack.
Vascepa can safely lower triglyceride levels, thus also helping reduce cardiovascular risk. However, the mechanisms through which the drug achieves this remain unclear.
Nevertheless, a clinical trial involving 8,179 participants has demonstrated the drug’s effectiveness and safety, ultimately leading to its approval by the FDA.
The participants were all aged 45 or older with a history of various heart, vascular, or metabolic conditions. These included coronary artery disease, cerebrovascular disease, carotid artery disease, peripheral artery disease, or diabetes. They also had additional risk factors for cardiovascular disease.
The trial showed that people who took Vascepa had a lower risk of experiencing a cardiovascular event than those who did not take the drug.
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.
The makers of Vascepa advise that people who receive a prescription for the drug take two 1-gram capsules or four 0.5-gram capsules twice per day with food.
However, 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.