Icosapent ethyl: drug profile and evidence of reduced residual cardiovascular risk in patients with statin-managed LDL-C cholesterol

ABSTRACT

Introduction:

Icosapent ethyl (IPE) is a highly purified (>96%) form of eicosapentanoic acid, a marine-derived omega-3 fatty acid known to reduce serum triglyceride (TG) levels. In the Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial (REDUCE-IT), the addition of 4 g IPE daily resulted in a 25% reduction in cardiovascular events beyond statins and other standard of care therapies. IPE is now the only therapy currently approved by the Food and Drug Administration to treat patients with elevated TGs (150–499 mg/dL) with cardiovascular disease (CVD) or Type 2 diabetes mellitus and two or more CVD risk factors.

Areas covered

• IPE is a highly purified form of eicosapentanoic acid for patients with elevated TGs as monotherapy or combined with statins and/or other lipid lowering therapies.

• The REDUCE-IT Study demonstrated a 25% reduction in the primary outcome measure and 30% reduction in total CVD events in high-risk patients with elevated TGs (135–499 mg/dL) assigned to IPE (4 g daily).

• Side effects included a statistically significant increased risk of atrial fibrillation and bleeding, although the risk of stroke was reduced and there were no cases of fatal bleeding.

• The FDA recently approved IPE for treatment of patients with TG levels of 150–499 mg/dL and preexisting CVD or Type 2 diabetes mellitus with two or more risk factors.

Expert opinion

IPE has proven to be superior to other forms of omega 3 fatty acid in reducing CVD risk in patients with elevated TG. This could be attributed to multiple factors including the use of highly purified eicosapentaenoic acid ethyl esters without docosahexaenoic acid (DHA), thus preventing the increase in low-density lipoprotein cholesterol associated with DHA especially at high TG levels, reduction in atherogenic TG-rich particles, antioxidant and anti-inflammatory properties, improvement in endothelial function, and stabilization of atherosclerotic plaque.

KEYWORDS:

• Triglycerides
• omega 3 fatty acids
• icosapent ethyl
• eicosapentanoic acid
• clinical trials
• REDUCE-IT
• cardiovascular disease

Declaration of interest

M Miller is a scientific advisor for Amarin and Steering Committee Member of the REDUCE-IT trial. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.