What is Vascepa (icosapent ethyl) used for?

What is Vascepa Used For?

Vascepa (icosapent ethyl) is a high-purity prescription omega-3 fatty acid (eicosapentaenoic acid ethyl ester) used to reduce cardiovascular risk in patients already on statin therapy who have elevated triglycerides (≥150 mg/dL) and either established cardiovascular disease or diabetes with additional risk factors. 1

Primary FDA-Approved Indications

Cardiovascular Risk Reduction

Vascepa is indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with elevated triglycerides (≥150 mg/dL) and either established cardiovascular disease OR diabetes mellitus with two or more additional cardiovascular risk factors. 1

• The REDUCE-IT trial demonstrated a 25% relative risk reduction in major adverse cardiovascular events (cardiovascular death, nonfatal MI, nonfatal stroke, coronary revascularization, or unstable angina) when icosapent ethyl 4 g/day was added to statin therapy. 1
• The trial enrolled 8,179 patients with triglycerides 135-499 mg/dL (median 216 mg/dL) and LDL-C 41-100 mg/dL on statin therapy, with 71% having established ASCVD and 29% having diabetes with multiple risk factors. 1
• Cardiovascular death was reduced by 20% (P = 0.03) in the icosapent ethyl group. 1

Severe Hypertriglyceridemia

Vascepa was initially approved at 4 g/day as an adjunct to diet to reduce triglyceride levels ≥500 mg/dL in adult patients with severe hypertriglyceridemia. 2, 3

• In the MARINE trial, icosapent ethyl reduced triglycerides by approximately 33% in patients with very high baseline triglycerides (≥500 mg/dL). 2, 3
• Unlike omega-3 formulations containing both EPA and DHA, icosapent ethyl does not increase LDL-C levels. 2, 3, 4

Specific Clinical Scenarios for Use

Stroke Prevention

In patients with ischemic stroke or TIA, with fasting triglycerides 135-499 mg/dL and LDL-C 41-100 mg/dL on moderate- or high-intensity statin therapy, with HbA1c <10% and no history of pancreatitis, atrial fibrillation, or severe heart failure, icosapent ethyl 2 g twice daily is reasonable to reduce risk of recurrent stroke. 1

• The REDUCE-IT trial showed the same 25% reduction in nonfatal stroke and TIA as in the overall MACE endpoint. 1
• No difference occurred in hemorrhagic stroke rates. 1

Diabetes with Cardiovascular Risk Factors

In patients with diabetes and ASCVD or other cardiovascular risk factors on a statin with controlled LDL cholesterol but elevated triglycerides (135-499 mg/dL), icosapent ethyl should be considered to reduce cardiovascular risk. 1

• Almost 60% of the REDUCE-IT trial cohort had type 2 diabetes. 1
• Benefits were similar across baseline triglyceride levels and unrelated to triglyceride levels attained, suggesting mechanisms beyond triglyceride lowering. 1

Dosing and Administration

The standard dose is 2 g twice daily (4 g/day total) taken with food. 1, 2

• Icosapent ethyl produces dose-dependent increases in EPA concentrations in plasma and red blood cells, which correlate with triglyceride-lowering effects. 4
• At 4 g/day, end-of-treatment plasma EPA concentrations exceed 170 μg/mL and RBC EPA concentrations exceed 70 μg/mL. 4

Important Safety Considerations

Atrial Fibrillation Risk

Monitor for increased risk of atrial fibrillation, which occurred in 5.3% of icosapent ethyl-treated patients versus 3.9% of controls in REDUCE-IT. 1, 5

Contraindications and Precautions

• Icosapent ethyl is contraindicated in patients with known hypersensitivity to icosapent ethyl or any component of the formulation. 2
• Use with caution in patients with known hypersensitivity to fish and/or shellfish. 2
• The formulation should not be confused with dietary fish oil supplements, which are not equivalent to prescription formulations. 1, 3

Key Distinctions from Other Omega-3 Products

Icosapent ethyl is the only omega-3 fatty acid product with proven cardiovascular outcomes benefit when added to statin therapy. 1, 5

• Unlike mixed EPA/DHA formulations, icosapent ethyl does not increase LDL-C levels. 2, 3
• The STRENGTH trial with a different omega-3 carboxylic acid formulation (EPA + DHA) failed to show cardiovascular benefit, highlighting that results with icosapent ethyl should not be extrapolated to other omega-3 products. 1, 6
• Over-the-counter fish oil supplements are not equivalent to prescription icosapent ethyl and should not be substituted. 1, 5