From the Guidelines
Vascepa (icosapent ethyl) is indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of cardiovascular events in adults with elevated triglyceride levels (≥150 mg/dL) and either established cardiovascular disease or diabetes mellitus plus two or more additional risk factors for cardiovascular disease. The medication's effectiveness was demonstrated in the REDUCE-IT trial, which showed significant reduction in cardiovascular events including heart attacks, strokes, and cardiovascular death 1. Key points to consider when prescribing Vascepa include:
- Typical dosage is 4 grams daily, taken as two 2-gram capsules twice daily with food
- Vascepa works through its active ingredient, icosapent ethyl, which is a highly purified form of the omega-3 fatty acid EPA (eicosapentaenoic acid)
- Unlike other omega-3 products, Vascepa contains only EPA without DHA, which may help explain its cardiovascular benefits without raising LDL cholesterol
- Common side effects include joint pain, peripheral edema, constipation, and atrial fibrillation, and it may increase bleeding risk, so caution is advised in patients on anticoagulants
- The 2021 ACC expert consensus decision pathway on the management of ASCVD risk reduction in patients with persistent hypertriglyceridemia also supports the use of icosapent ethyl for ASCVD risk reduction in specific patients 1
- Additionally, the 2022 standards of medical care in diabetes recommend considering the addition of icosapent ethyl to reduce cardiovascular risk in patients with atherosclerotic cardiovascular disease or other cardiovascular risk factors on a statin with controlled LDL cholesterol but elevated triglycerides (135–499 mg/dL) 1.
From the FDA Drug Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 35916-1738-1 Icosapent Ethyl Capsules 0.5 gram 240 capsules Rx only NDC 35916-1592-1 Icosapent Ethyl Capsules 1 gram 240 capsules Rx only The FDA drug label does not answer the question.
From the Research
Vascepa Indication
- Vascepa (icosapent ethyl) is indicated for the treatment of severe hypertriglyceridemia (triglyceride levels ≥ 500 mg/dL) in adults 2, 3, 4.
- It is also approved as an adjunct to a maximally tolerated statin to reduce the risk of cardiovascular events in adults with triglyceride levels > 150 mg/dL and established cardiovascular disease or diabetes with two or more additional cardiovascular risk factors 5.
- In patients with mild-to-moderate hypertriglyceridemia (triglyceride levels ≥ 150 mg/dL and < 500 mg/dL), icosapent ethyl may be considered for added treatment to further reduce cardiovascular disease risk in those with prior cardiovascular disease or diabetes mellitus and at least two additional cardiovascular disease risk factors, who are already on maximally tolerated statin therapy 6.
Key Benefits
- Vascepa has been shown to significantly decrease triglyceride levels without increasing low-density lipoprotein cholesterol (LDL-C) levels 2, 4.
- It has a favorable effects on other lipid parameters and a tolerability profile similar to that of placebo 2.
- Vascepa may provide a new alternative with potential benefits over currently available treatments for dyslipidemia 4.
Patient Population
- Adults with severe hypertriglyceridemia (triglyceride levels ≥ 500 mg/dL) 2, 3, 4.
- Adults with established cardiovascular disease or diabetes with two or more additional cardiovascular risk factors and triglyceride levels > 150 mg/dL 5.
- Patients with mild-to-moderate hypertriglyceridemia (triglyceride levels ≥ 150 mg/dL and < 500 mg/dL) who are already on maximally tolerated statin therapy 6.