Amarin’s Vascepa Shows Reduced Ischemic Events in Patients With Previous PAD in REDUCE-IT Subgroup Analysis

November 15, 2021—Amarin Corporation plc announced new data on Vascepa/Vazkepa (icosapent ethyl) in patients with previous peripheral artery disease (PAD) at risk for major adverse cardiovascular events.

Deepak L. Bhatt, MD, delivered “Benefits of Icosapent Ethyl in Patients with Prior Peripheral Artery Disease: REDUCE-IT PAD” in a Rapid-Fire Oral Session presentation at AHA 2021, the American Heart Association Scientific Sessions held virtually November 13-15. Dr. Bhatt, who serves as Principal Investigator of REDUCE-IT, is Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School in Boston, Massachusetts.

According to the company, the presentation included both prespecified and post hoc analyses of patients who had PAD before randomization in the REDUCE-IT study to determine if treatment with Vascepa reduced further ischemic events in those patients.

“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 in Amarin’s press release. “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 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.”

As reported in the company announcement, the investigators concluded, “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.”

The investigators continued, “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.”

They further reported, “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% vs 2.6%; P = .07). No differences in bleeding were observed between icosapent ethyl and placebo in patients with prior PAD, likely due to the sample size.”

Amarin advised that REDUCE-IT is a global cardiovascular outcomes study designed to evaluate the effect of Vascepa in adult patients with low-density lipoprotein cholesterol controlled to between 41 to 100 mg/dL (median baseline, 75 mg/dL) by statin therapy and various cardiovascular risk factors, including persistent elevated triglycerides between 135 to 499 mg/dL (median baseline, 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort). The study, which was conducted for 7 years and completed in 2018, followed 8,179 patients at > 400 clinical sites in 11 countries with the largest number of sites located within the United States.