Primary composite first and total major adverse cardiovascular event (MACE) reductions of 23% each shown with VASCEPA in prespecified tertiary and post hoc exploratory analyses of the subgroup of people with diabetes

Key secondary composite first and total MACE reductions of 30% and 29%, respectively, shown with VASCEPA in prespecified tertiary and post hoc exploratory subgroup analyses

Reductions also observed in post hoc exploratory analyses of other composite endpoints, in people with diabetes, and in people with established cardiovascular disease with or without diabetes at baseline

DUBLIN, Ireland and BRIDGEWATER, N.J., June 15, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that data from the REDUCE-IT® study presented during the 80th Scientific Sessions of the American Diabetes Association by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s Hospital Heart & Vascular Center and Harvard Medical School, showed that administration of 4 g/day of VASCEPA® (icosapent ethyl) resulted in significant 23% reductions in both first and total primary composite major adverse cardiovascular events (5-point MACE) in people with diabetes. Reductions of 30% and 29% were observed in both first and total hard (3-point) MACE, the key secondary composite endpoint, respectively. The late-breaking presentation, titled “Substantial Cardiovascular Benefit from Icosapent Ethyl in Patients with Diabetes: REDUCE-IT DIABETES” was heard on June 13, 2020 at 10:00 am CST. 

The leading cause of morbidity and mortality in type 2 diabetes mellitus continues to be cardiovascular disease, especially in those patients who already have established atherosclerotic cardiovascular disease (ASCVD).1  Above normal blood levels of triglycerides (TG) are common in patients with diabetes,2,3 and have been associated with increased ASCVD (30% and 23% higher risk for non-fatal myocardial infarction (MI) and stroke, respectively) in this patient population, despite statin therapy.4

Many of the world’s leading diabetes and cardiovascular disease professional societies, including the American Diabetes Association (ADA) and the American Heart Association (AHA), are working to educate patients and clinicians on the urgent need to identify and manage risk with appropriate therapies. The AHA Scientific Statement on Clinical Management of Stable Coronary Artery Disease in Patients with Type 2 Diabetes Mellitus, published in April of this year, states that “icosapent ethyl is the first non–LDL (low-density lipoprotein)-focused lipid therapy to demonstrate cardiovascular benefit and should be considered first-line therapy for patients with T2DM (type 2 diabetes mellitus) and CAD (coronary artery disease) whose triglycerides remain elevated (>135 mg/dL) despite maximally tolerated statin and lifestyle changes.”1  

“People with diabetes are at markedly increased risk of cardiovascular disease, and that intersection has become a target for research and a focus for clinical care,” commented Dr. Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital Heart & Vascular Center and Professor of Medicine at Harvard Medical School, and senior author of the REDUCE-IT DIABETES analyses. “In these analyses, we see the substantial impact that icosapent ethyl could have on reducing cardiovascular risks and complications from diabetes.” 

The prespecified tertiary and post hoc exploratory analyses from the REDUCE-IT study showed that, for the primary composite endpoint of 5-point MACE, time to first event was significantly reduced with VASCEPA versus placebo by 23% (p