What is the use of Vascepa (Icosapent ethyl)?

From the Guidelines

Vascepa (icosapent ethyl) should be considered for patients with atherosclerotic cardiovascular disease or other cardiovascular risk factors on a statin with managed LDL cholesterol but elevated triglycerides (150–499 mg/dL) to reduce cardiovascular risk, as evidenced by the Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (REDUCE-IT) 1.

Key Points

• The standard dose of Vascepa is 2 grams (two 1-gram capsules) taken twice daily with food.
• Vascepa contains a purified form of eicosapentaenoic acid (EPA), an omega-3 fatty acid derived from fish oil.
• It works by reducing inflammation, improving endothelial function, and stabilizing atherosclerotic plaques, which helps prevent heart attacks, strokes, and other cardiovascular events.
• Unlike over-the-counter fish oil supplements, Vascepa is highly purified and contains only EPA without docosahexaenoic acid (DHA).
• Common side effects include joint pain, muscle pain, and swelling.
• Patients taking blood thinners should use Vascepa cautiously due to increased bleeding risk.
• For maximum benefit, Vascepa should be taken consistently as prescribed alongside other heart-healthy measures like diet, exercise, and other medications recommended by your healthcare provider.

Benefits and Risks

• The REDUCE-IT trial demonstrated a 25% relative risk reduction (P < 0.001) for the primary end point composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina 1.
• The composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was reduced by 26% (P < 0.001) 1.
• Additional ischemic end points were significantly lower in the icosapent ethyl group than in the placebo group, including cardiovascular death, which was reduced by 20% (P = 0.03) 1.
• The proportions of patients experiencing adverse events and serious adverse events were similar between the active and placebo treatment groups 1.

From the FDA Drug Label

Icosapent ethyl capsules are an ethyl ester of eicosapentaenoic acid (EPA) indicated: as an adjunct to diet to reduce TG levels in adultpatients with severe (≥ 500 mg/dL) hypertriglyceridemia. The main use of Vascepa is to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (≥ 500 mg/dL) as an adjunct to diet 2. Key points about Vascepa include:

• It is used to reduce TG levels in adults with severe hypertriglyceridemia
• It is an adjunct to diet, not a replacement for dietary changes
• The effect of Vascepa on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined 2 2.

From the Research

Vascepa Overview

• Vascepa, also known as icosapent ethyl, is a high-purity ethyl ester of eicosapentaenoic acid (EPA) used to lower triglyceride levels in adults with severe hypertriglyceridemia 3, 4.
• It is de-esterified to EPA following oral administration and contains ≥96 % of the EPA ethyl ester, without docosahexaenoic acid (DHA) 3.

Efficacy and Safety

• Vascepa has been shown to significantly decrease triglyceride levels, with a 33.1 % reduction in placebo-corrected median triglyceride levels in a pivotal phase III trial 3.
• It has a favorable effects on other lipid parameters and a tolerability profile similar to that of placebo 3, 4.
• Vascepa has been associated with a reduced risk of cardiovascular events, including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke 5.

Indications and Usage

• Vascepa is approved in the USA for use as an adjunct to diet to lower triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia 3, 4.
• It is also approved as an adjunct to a maximally tolerated statin to reduce the risk of cardiovascular events in adults with serum triglycerides > 150 mg/dL and established cardiovascular disease or diabetes and two or more additional cardiovascular disease risk factors 6, 7.

Clinical Trials

• The REDUCE-IT trial demonstrated that Vascepa significantly reduced the risk of ischemic events, including cardiovascular death, in patients with elevated triglyceride levels despite statin therapy 5.
• Other clinical trials, such as MARINE and ANCHOR, have also shown the efficacy and safety of Vascepa in reducing triglyceride levels and cardiovascular risk 4.