From the Guidelines
Vascepa (icosapent ethyl) is FDA-approved for two main indications: as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (≥500 mg/dL) at a dose of 2 grams twice daily, and to reduce cardiovascular risk in adults with elevated triglycerides (≥150 mg/dL) who have established cardiovascular disease or diabetes plus two additional risk factors at a dose of 2 grams twice daily. The lower dose of 1 gram twice daily is not proven effective for cardiovascular risk reduction. The cardiovascular benefit was demonstrated in the REDUCE-IT trial, which specifically used the 4 gram daily dose (2 grams twice daily) and showed significant reduction in major adverse cardiovascular events, as reported in the 2023 standards of care in diabetes 1. Patients should take Vascepa with food and continue statin therapy as prescribed. The medication works through multiple mechanisms including anti-inflammatory effects, improved endothelial function, and antithrombotic properties, not just through triglyceride lowering. Common side effects include arthralgia, peripheral edema, and atrial fibrillation. For optimal cardiovascular benefit, patients should adhere to the full 4 gram daily dose as lower doses have not demonstrated the same cardiovascular protection in clinical trials, as also supported by the 2020 standards of medical care in diabetes 1 and the 2021 ACC expert consensus decision pathway on the management of ASCVD risk reduction in patients with persistent hypertriglyceridemia 1. Key points to consider in the management of hypertriglyceridemia include:
- Evaluating for secondary causes of hypertriglyceridemia and considering medical therapy to reduce the risk of pancreatitis in patients with fasting triglyceride levels ≥500 mg/dL 1
- Addressing and treating lifestyle factors, secondary factors, and medications that raise triglycerides in adults with moderate hypertriglyceridemia (fasting or non-fasting triglycerides 175–499 mg/dL) 1
- 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 Indications
- Vascepa (icosapent ethyl) is indicated for the treatment of severe hypertriglyceridemia (triglyceride levels ≥ 500 mg/dL) in adult patients 2, 3.
- It is also indicated for the reduction of risk of cardiovascular events in patients with established cardiovascular disease or diabetes and other risk factors, who have triglyceride levels ≥ 150 mg/dL and are on statin therapy 4, 5.
Lower Dose for Cardio Benefit
- The standard dose of Vascepa for cardiovascular benefits is 4 g/day, given as 2 g twice daily 5.
- There is no established lower dose of Vascepa that has been shown to be effective for cardiovascular benefits in patients with hypertriglyceridemia.
- However, studies have shown that Vascepa at a dose of 4 g/day can significantly reduce triglyceride levels and cardiovascular events in patients with hypertriglyceridemia and established cardiovascular disease or diabetes 5, 6.
Key Benefits
- Vascepa has been shown to lower triglyceride levels, non-high-density lipoprotein cholesterol, and other atherogenic lipoproteins without increasing low-density lipoprotein cholesterol levels 2, 3.
- It has also been shown to reduce the risk of cardiovascular events, including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and unstable angina 5.