Icosapent Ethyl for the Prevention of Cardiovascular Events

Icosapent ethyl is now listed on the Pharmaceutical Benefits Scheme (PBS) for patients with established atherosclerotic cardiovascular disease with hypertriglyceridaemia. To be eligible for PBS-subsidy, treatment must be in conjunction with lifestyle modification and a statin (unless contraindicated or not tolerated).

Icosapent ethyl is a stable and highly purified ester of the omega-3 fatty acid, eicosapentaenoic acid (EPA). Following oral administration, icosapent ethyl is de-esterified to release EPA, the active metabolite. While the mechanism of action is not completely understood, icosapent ethyl produces reduced triglyceride levels, antiplatelet effects, anti-inflammatory effects, reduced blood pressure, and stabilisation of atherosclerotic plaques.

The effectiveness of icosapent ethyl was evaluated in the REDUCE-IT trial. This trial included over 8,000 statin-treated patients who had established cardiovascular disease or diabetes and other risk factors. Patients were randomly assigned to receive icosapent ethyl (2g twice daily) or placebo. The primary endpoint (a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularisation, or unstable angina) occurred in 17.2% of the icosapent ethyl group compared to 22.0% of placebo.

Overall, the rates of adverse events did not differ significantly between the two groups. However, the rate of atrial fibrillation was higher in the icosapent ethyl group (5.3% vs 3.9%). The manufacturer recommends monitoring for clinical evidence of atrial fibrillation or flutter. Caution is required in patients with a known hypersensitivity to fish or shellfish, as icosapent ethyl is derived from fish oil.