Vascepa is a prescription omega-3 medicine made from a purified form of one fish oil fatty acid, EPA. It is used for two different reasons: to bring very high triglycerides down, and, in people already taking a statin, to lower the risk of heart attack and stroke. It is not the same as a fish oil supplement, it has its own side effects, including a higher risk of an irregular heartbeat and bleeding, and it does not suit everyone. This guide explains what Vascepa is, who it is for, what the trials showed, its side effects, how it differs from fish oil and Lovaza, and what to do if your triglycerides stay high.
Triglycerides still 450 or higher?
A study is testing an investigational medicine for adults with triglycerides between 450 and 2,000 mg/dL, alongside the medicines they already take.
What is Vascepa?
Vascepa is the brand name for icosapent ethyl, a highly purified ethyl ester of eicosapentaenoic acid (EPA), one of the omega-3 fatty acids found in fish. It comes as capsules, and the usual dose is 4 grams a day, taken as 2 grams twice a day with food. Generic icosapent ethyl is also available. It is a prescription medicine, approved and regulated by the FDA, unlike over-the-counter fish oil.
What is Vascepa used for?
Vascepa is approved for two uses:
- Lowering the risk of heart attack and stroke. Since December 2019, it has been approved alongside the highest statin dose a person can tolerate, to reduce the risk of heart attack, stroke, procedures to open the heart arteries, and hospital stays for unstable angina, in adults with triglycerides of 150 mg/dL or higher who also have heart or blood vessel disease, or diabetes plus at least two other risk factors.
- Lowering very high triglycerides. Together with diet, it is approved to lower triglycerides in adults with levels of 500 mg/dL or higher. The prescribing information notes that its effect on the risk of pancreatitis, the main danger of very high triglycerides, has not been determined.
What the REDUCE-IT trial showed
The heart approval was based on the REDUCE-IT trial, in which people with raised triglycerides who were already on a statin and at high cardiovascular risk took either Vascepa or a placebo. Those on Vascepa had a 25 percent lower risk of major cardiovascular events. The reduction was larger than its modest effect on triglycerides alone would suggest, and researchers are still debating exactly how it works; part of the discussion has been about the mineral oil used as the placebo in that trial.
Vascepa side effects
In the cardiovascular outcomes trial, the side effects reported in at least 3 percent of people and more often than with placebo were:
- muscle and joint pain
- swelling of the legs, ankles, or hands (peripheral edema)
- constipation
- gout
- atrial fibrillation, a type of irregular heartbeat
In the trials of people with very high triglycerides, joint pain and sore throat were reported more often than with placebo.
Warnings: heart rhythm and bleeding
Irregular heartbeat. Vascepa is linked to a higher risk of atrial fibrillation or atrial flutter that needed hospital care, and the risk is greater in people who have had these rhythm problems before. Tell your doctor about palpitations, a racing or irregular heartbeat, dizziness, or new breathlessness.
Bleeding. Bleeding events, including serious ones, were more common with Vascepa, and the risk is higher in people who also take blood thinners or antiplatelet medicines such as aspirin or clopidogrel. Report unusual bruising, blood in the urine or stool, or bleeding that is hard to stop.
Fish or shellfish allergy. Because Vascepa comes from fish oil, people with a fish or shellfish allergy should discuss it with their doctor before starting.
Vascepa vs fish oil and Lovaza
Over-the-counter fish oil supplements are not approved by the FDA as medicines contain much lower and variable amounts of omega-3s, and have not been shown to deliver the cardiovascular benefit seen with Vascepa in REDUCE-IT, so they are not a substitute for it. Lovaza (omega-3 acid ethyl esters) is another prescription omega-3, but it contains both EPA and DHA, and it is approved only for very high triglycerides, not for lowering cardiovascular risk. Vascepa contains EPA alone.
Vascepa vs fenofibrate
Both are used for high triglycerides, but they work differently and have different side effects. Fenofibrate lowers triglycerides strongly but has not been shown to reduce heart attacks and strokes when added to a statin; Vascepa has a cardiovascular approval based on REDUCE-IT, though its effect on triglycerides is more modest. Some people take one, some both, depending on their levels and risk.
Our guide covers fenofibrate side effects.
When triglycerides stay very high
If your triglycerides remain very high despite treatment, doctors usually look again at what drives them: blood sugar in type 2 diabetes, alcohol, weight, thyroid function, and other medicines. Several newer treatments for very high triglycerides have arrived in recent years, and more are being tested in clinical trials.
After a heart attack, triglycerides are one part of the remaining risk; our guide explains why standard prevention is not always enough.
A study of an investigational medicine called MAR001 is enrolling adults whose triglycerides are between 450 and 2,000 mg/dL. Participants can keep taking their current cholesterol and triglyceride medicines, including Vascepa, which may be adjusted at the start, and receive an injection of MAR001 or a placebo every four weeks for 24 weeks. People with a recent episode of pancreatitis, or who already take one of the newest triglyceride-lowering injections, are not eligible. Sites are open in several US states and in Canada. Our guide explains how placebo-controlled trials work, and nothing is decided until you have gone through informed consent.
Common questions
What is Vascepa used for? To lower the risk of heart attack and stroke in adults on a statin with triglycerides of 150 mg/dL or higher and heart disease or diabetes with other risk factors, and to lower triglycerides of 500 mg/dL or higher together with diet.
What are the most common side effects of Vascepa? Muscle and joint pain, swelling of the legs or hands, constipation, gout, and atrial fibrillation. In people with very high triglycerides, joint pain and sore throat were also reported.
Does Vascepa cause bleeding? It can increase the risk of bleeding, especially with blood thinners or antiplatelet medicines. Tell your doctor about all the medicines you take.
Is Vascepa the same as fish oil? No. It is a purified prescription form of EPA, regulated by the FDA, and it showed a cardiovascular benefit in the REDUCE-IT trial. Fish oil supplements are not a substitute.
Is there a generic Vascepa? Yes, generic icosapent ethyl is available.
What is the difference between Vascepa and Lovaza? Vascepa contains EPA only and is approved both for very high triglycerides and for lowering cardiovascular risk. Lovaza contains EPA and DHA and is approved only for very high triglycerides.
Do triglyceride trial participants get paid? Some studies offer compensation for time and travel, and study related care is typically provided at no cost to participants. Compensation varies by trial and is always described during the informed consent process before you agree to anything.