What You Need to Know About Vascepa (Icosapent Ethyl)

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If your triglyceride levels are elevated, your healthcare provide may decide to try and lower your levels through changing up your lifestyle. This includes making your diet healthier, losing weight, or addressing medical conditions - such as uncontrolled diabetes - that could be causing your triglyceride levels to be too high. If these changes don't work - or if your triglycerides are extremely elevated - your healthcare provider may decide to add medication.

This is when medications like Vascepa may be prescribed to you.

Vascepa (icosapent ethyl) is a modified form of the omega-3 fatty acid, eicosapentaenoic acid (EPA), and is taken by people who have been diagnosed with severe hypertriglyceridemia, which consists of triglyceride levels greater than or equal to 500 mg/dL. If you have been prescribed this medication to take, you should also be following a diet to lower your triglyceride levels. Vascepa was approved for use in the United States by the Food and Drug Administration (FDA) in July 2012.

There a few studies that have examined the safety and effectiveness of Vascepa in lowering triglycerides. The pivotal study, the MARINE trial, compared the triglyceride-lowering ability of Vascepa to placebo in people with triglyceride levels between 500 and 2000 mg/dL over a 12 week period. Compared to placebo, triglyceride levels were lowered by roughly 33% in those taking 4 grams of Vascepa daily.

Additionally, VLDL was lowered by 28.6%. LDL and HDL were slightly lowered, however, this reduction was not statistically significant. No significant differences in vital signs, blood sugar levels, and liver enzymes were noted in people taking Vascepa versus those taking a placebo.

How Does Vascepa Work?

Vascepa works by reducing the amount of triglycerides made in the liver.

Additionally, Vascepa increases the removal of triglycerides from VLDL particles that are circulating in your blood. The exact manner by which Vascepa does this is not known, although there have been several mechanisms proposed.

How Should You Take This Medication?

You should take Vascepa as prescribed by your healthcare provider. A typical dose of Vascepa consists of taking two capsules twice a day (totaling 4 grams). The capsules should be taken with food and should not be crushed, chewed, or cut in half. You should also be following a healthy lifestyle - such as getting moderate exercise and following a healthy diet - before and while taking Vascepa.

What Side Effects Should I Expect While Taking Vascepa?

In studies, the most common side effects reported were diarrhea and nausea, although many people taking the placebo also experienced these side effects. You also might experience joint pain and sore throat, since these side effects were also noted in people taking Vascepa.

You should let your healthcare provider know what types of side effects you are experiencing while taking Vascepa - especially if they become bothersome or interfere with your daily activities.

 

Who Should Not Take This Medication?

You shouldn't take Vascepa if you have ever had a severe allergic reaction to Vascepa or any of its ingredients. Because the modified EPA has been obtained from oils derived from fish, Vascepa should be used with caution if you have an allergy to fish or shellfish. Vascepa has not been studied in people who have a fish or shellfish allergy.

Vascepa has also not been extensively studied in people with kidney or liver disease. If you have liver or renal disease or impairment, you should let your healthcare provider know. He or she will decide whether or not Vascepa is appropriate for you and monitor your condition while you are on the medication.

This product has also not been studied in pregnant or breastfeeding women. Therefore, Vascepa should be taken only if clearly needed.

Will This Medication Interact with Other Drugs that I Am Taking?

There does not appear to be many interactions between Vascepa and other medications. Although Vascepa did not appear interact with anticoagulant medications or to have a significant effect on bleeding, other studies have shown that high doses of omega-3 fatty acids may decrease the ability of your blood to clot. Therefore, if you are taking any type of medication that affects your blood’s ability to clot, your healthcare provider will assess your anticoagulation status periodically. You should also let your healthcare provider know of you are taking any other medications, herbal supplements, or over-the-counter products before starting Vascepa.

Bottom Line

Studies have shown that Vascepa can lower triglyceride levels in people who have been diagnosed with very high triglyceride levels at or above 500 mg/dL. In addition to taking Vascepa, other factors that could increase triglyceride levels - such as diet, physical activity, other medications, or certain diseases, such hypothyroidism or diabetes - should also be addressed. Persistently elevated triglyceride levels have shown to lead to the development of cardiovascular disease and acute inflammation of the pancreas, or pancreatitis. Vascepa has not been studied in preventing cardiovascular disease long-term or pancreatitis, although there appears to be a study underway examining the Vascepa’s ability to prevent the first cardiovascular event in people with very high triglycerides.

Sources:

Ballantyne CM, Bays HE, Kastelein JJ et al. Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin treated patients with persistent high triglycerdies (from the ANCHOR study). Am J Cardiol 2012;110:982-992.

Bays HE, Braeckman RA, Ballantyne CM, et al. Icosapent ethyl, a pure EPA omega-3 fatty acid: effects on lipoprotein particle concentration and size in patients with very high triglyceride levels (the MARINE study). J Clin Lipidol 2012;6:565-572.

Nelson SD, Munger MA. Icosapent ethyl for treatment of elevated triglyceride levels. Ann Pharmacother 2013;27:1517-1523.

Vascepa® (icosapent ethyl) Package Insert. Amarin Pharmaceuticals. June 2015.

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