Benzinga | Nov 15, 2021 05:07PM EST

Amarin Highlights Subgroup Data From REDUCE-IT Shows Benefits Of VASCEPA/VAZKEPA In Patients With Prior Peripheral Artery Disease Presented At Oral Session Presentation For American Heart Association Scientific Sessions Nov. 13-15

VASCEPA/VAZKEPA found in prespecified and post hoc analyses to reduce total ischemic events by 32% in patients with prior PAD

DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that data adding to the growing body of knowledge on VASCEPA(r)/VAZKEPA (icosapent ethyl) in patients with prior peripheral artery disease (PAD) at risk for major adverse cardiovascular events were delivered in a Rapid Fire Oral Session Presentation at the American Heart Association (AHA) Scientific Sessions 2021, which took place virtually from November 13-15, 2021.

The presentation, titled, "Benefits of Icosapent Ethyl in Patients with Prior Peripheral Artery Disease: REDUCE-IT PAD," was presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital, Professor of Medicine at Harvard Medical School, and principal investigator of REDUCE-IT(r) and was available On-Demand beginning on November 13, 2021 at 8:00 am ET through the completion of AHA Scientific Sessions 2021.

The Rapid Fire Oral Session presentation included both prespecified and post hoc analyses of patients who had PAD prior to randomization in the REDUCE-IT study to determine if treatment with VASCEPA (icosapent ethyl) reduced further ischemic events in those subjects.

"The REDUCE-IT prior PAD analyses provide valuable data supporting a potentially effective new approach to prevent ischemic events using prescription icosapent ethyl in patients with prior PAD," commented Dr. Bhatt. "The potential benefits for patients with prior PAD are particularly important given these patients are at significantly higher risk of cardiovascular morbidity and mortality. These results strongly support the case for pure eicosapentaenoic acid (EPA) in the form of prescription icosapent ethyl as a key intervention beyond statins for meaningful risk reduction by physicians caring for their high-risk PAD patients."

The investigators concluded that, "Icosapent ethyl 4 g/day significantly reduced total (first and subsequent) primary endpoints by 32%, and trended toward a 22% reduction in first events, in patients with PAD. Icosapent ethyl provides substantial cardiovascular risk reduction in the high-risk REDUCE-IT population, with consistent benefits in patients with a history of PAD. Safety was generally consistent with the overall study. Overall tolerability and adverse events were generally similar between icosapent ethyl and placebo in patients with prior PAD. More atrial fibrillation/flutter occurred with icosapent ethyl versus placebo in patients with prior PAD (5.2% versus 2.6%, respectively; P=0.07). No differences in bleeding were observed between icosapent ethyl and placebo in patients with prior PAD, likely due to the sample size."

"Amarin is committed to serving patients at high risk of cardiovascular events and these new data add to our growing body of clinical evidence in support of its benefits to reduce that risk in patients with prior PAD," stated Steven Ketchum, Ph.D., executive vice president and president, research & development and chief scientific officer, Amarin. "For these patients, the demonstrated cardiovascular risk reduction of VASCEPA/VASKEPA could be an important, and potentially life-saving, addition to their treatment regimen."

Additional REDUCE-IT and icosapent ethyl-related topics to be presented at AHA Scientific Sessions 2021 can be found here.

Dr. Bhatt receives research funding paid to Brigham and Women's Hospital from Amarin for his role as the Chair of REDUCE-IT.