The U.S. Food and Drug Administration has approved an omega-3 fatty acid treatment as an add-on treatment to statin therapy to reduce the risk of cardiovascular disease in adults with elevated triglyceride levels.
It is the first treatment approved as add-on therapy for this condition.
Icosapent ethyl (Vascepa, Amarin Pharma) is designed to lower high triglycerides levels in adults without raising bad cholesterol (LDL-C), which over-the-counter fish oil supplements can do.
In order to receive icosapent ethyl, adults must have an LDL-C of at least 150 milligrams per deciliter, either established cardiovascular disease or diabetes, and two or more additional risk factors for cardiovascular disease. Patients are advised to continue physical activity and maintain a healthy diet.
Icosapent ethyl was approved in 2012 by the FDA as an adjunct treatment to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia of at least 500 mg/dL. The new indication announced in December is based on REDUCE-IT, a study of 8,179 adults with a history of coronary artery, cerebrovascular, carotid artery and peripheral artery disease, or diabetes with cardiovascular disease risk factors.
REDUCE-IT found that icosapent ethyl reduced total primary endpoint events (61 vs. 89 per 1,000 patient-years for icosapent ethyl versus placebo, respectively; rate ratio: 0.70; 95% confidence interval: 0.62 to 0.78; p < 0.0001). And, the treatment reduced totals for each component of the primary composite endpoint, as well as the total key secondary endpoint events (32 vs. 44 per 1,000 patient-years for icosapent ethyl versus placebo, respectively; rate ratio: 0.72; 95% confidence interval: 0.63 to 0.82; p < 0.0001).
“Ultimately, among statin-treated patients with elevated triglycerides and cardiovascular disease or diabetes, multiple statistical models demonstrate that icosapent ethyl substantially reduces the burden of first, subsequent, and total ischemic events,” wrote the authors of a REDUCE-IT study published in June in the Journal of the American College of Cardiology.
The treatment was found to be associated with an increased risk of atrial fibrillation, atrial flutter, and increased risk of bleeding events. The most common side effects included musculoskeletal pain, peripheral edema, atrial fibrillation and arthralgia.
Both the American Heart Association and American Society for Preventive Cardiology have recognized icosapent ethyl in combination with statins to reduce residual atherosclerotic cardiovascular disease (ASCVD), as among one of the most important advances in preventive cardiology of the decade.
“While many prior trials of fish oil therapy have failed to show benefit, the recent Reduction of Cardiovascular Events With EPA - Intervention Trial (REDUCE-IT) testing the efficacy of icosapent ethyl has shown dramatic benefit in further addressing residual atherosclerotic cardiovascular disease (ASCVD) risk beyond statin therapy not only in those with known ASCVD, but also in diabetic patients with multiple risk factors,” wrote Nathan D. Wong, M.D., of the University of California, Irvine. Dr. Wong and colleagues addressed these and other key cardiovascular disease findings of the past decade in the December 6 issue of Trends in Cardiovascular Medicine.