Is Vaksepa (Icosapent ethyl) a suitable treatment option for this patient?

From the Guidelines

Icosapent ethyl (Vascepa) may be a suitable treatment option for patients with established cardiovascular disease or diabetes plus additional risk factors who have triglyceride levels ≥150 mg/dL while on statin therapy, as it has been shown to reduce cardiovascular events in specific high-risk populations 1. To determine if icosapent ethyl is appropriate for this patient, we need to consider the following factors:

• The patient's lipid profile, including triglyceride levels
• The presence of established cardiovascular disease or diabetes plus additional risk factors
• The patient's current medication regimen, including statin therapy
• The patient's medical history and potential contraindications, such as fish or shellfish allergies Icosapent ethyl works by reducing triglyceride levels, which can help decrease the risk of cardiovascular events in high-risk populations. The standard dose is 2 grams twice daily with food. According to the most recent guidelines, the addition of icosapent ethyl can be considered to reduce cardiovascular risk in individuals with ASCVD or other cardiovascular risk factors on a statin with managed LDL cholesterol but elevated triglycerides (150–499 mg/dL) 1. Some key points to consider when evaluating the use of icosapent ethyl include:
• Hypertriglyceridemia should be addressed with nutritional and lifestyle changes, including weight loss and abstinence from alcohol
• Severe hypertriglyceridemia may warrant pharmacologic therapy to reduce the risk of acute pancreatitis
• Moderate- or high-intensity statin therapy should also be used as indicated to reduce risk of cardiovascular events Overall, icosapent ethyl may be a valuable treatment option for patients with hypertriglyceridemia and cardiovascular disease or diabetes, but its use should be carefully considered on a case-by-case basis, taking into account the patient's individual risk factors and medical history 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

Vaksepa (Icosapent Ethyl) as a Treatment Option

• Vaksepa, also known as icosapent ethyl, is a prescription formulation approved in the US for the treatment of adults with severe hypertriglyceridemia 2, 3.
• It is a high-purity ethyl ester of eicosapentaenoic acid (EPA) that is de-esterified to EPA following oral administration, and it does not contain docosahexaenoic acid (DHA) 3.
• Icosapent ethyl has been shown to significantly decrease triglyceride levels, with a pivotal phase III trial demonstrating a 33.1% reduction in placebo-corrected median triglyceride levels 3.

Efficacy and Safety

• Vaksepa has been found to be effective in reducing triglyceride levels and has a favorable safety profile, with the most common adverse events being gastrointestinal 2, 3.
• It has also been shown to have a lack of drug-drug interactions with other lipid-lowering drugs, such as statins and fibrates 2.
• A study found that switching from omega-3-acid ethyl esters to icosapent ethyl resulted in beneficial and substantial changes in the lipid profile, with a notable reduction in triglyceride levels and additional reductions in LDL-C levels 4.

Cardiovascular Risk Reduction

• Icosapent ethyl has been approved by the US FDA as an adjunct to a maximally tolerated statin to reduce the risk of cardiovascular disease events in adults with serum triglycerides > 150 mg/dL and established cardiovascular disease or diabetes and two or more additional cardiovascular risk factors 5.
• The REDUCE-IT trial demonstrated significant cardiovascular benefit with the use of icosapent ethyl in patients with atherosclerotic cardiovascular disease or diabetes with elevated risk on maximally tolerated statin 6.
• Current guidelines and expert consensus documents endorse therapeutic lifestyle interventions as the first-line therapy for treatment of hypertriglyceridemia, with icosapent ethyl considered for further cardiovascular risk reduction in patients with residual mild to moderate hypertriglyceridemia on maximally tolerated statin and elevated cardiovascular risk 6.