New REDUCE-IT Analyses Show VASCEPA (icosapent ethyl) Associated with 29 Percent Relative Risk Reduction Compared with Placebo in Prespecified Subgroup of Patients with Metabolic Syndrome, but Without Diabetes at Baseline

-- Analysis Also Found IPE Was Associated with a 41% Reduction in Total Events Compared with Placebo --

-- Subgroup Almost Exclusively Comprised of Patients with Established Cardiovascular Disease --

-- Findings Continue to Reinforce the Scientific Data and Clinical Use of VASCEPA/VAZKEPA to Reduce Cardiovascular Risk --

-- Results Presented Today at the American Heart Association (AHA) Scientific Sessions 2023 and Simultaneously Published in the European Heart Journal Open --

DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 12, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced results from new REDUCE-IT analyses showing that among statin-treated patients in a prespecified subgroup with history of Metabolic Syndrome, but without diabetes at baseline, the addition of VASCEPA/VAZKEPA (icosapent ethyl) significantly reduced the risk of first and total cardiovascular events. This subgroup was almost exclusively comprised of patients with established cardiovascular disease. The results were presented today at the American Heart Association (AHA) Scientific Sessions 2023, taking place November 11 – 13, 2023 in Philadelphia, PA and simultaneously published in the European Heart Journal Open.

More than 1 out of every 3 adult Americans have Metabolic Syndrome, a cluster of 3 or more of 5 risk factors: 1) waist circumference ≥40 inches [102 cm] in men and ≥35 inches [88 cm] in women, 2) blood pressure ≥130/85 mmHg, 3) glucose ≥100 mg/dL, 4) triglycerides ≥150 mg/dL, and 5) HDL-C <40 mg/dL in men and <50 mg/dL in women.

Among patients with Metabolic Syndrome but without diabetes at baseline (n=2866), those who were allocated to icosapent ethyl (IPE) treatment with a median follow-up time of 4.9 years experienced a 29% relative risk reduction for the primary composite endpoint, defined as cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina resulting in hospitalization (P <0.0001) (Absolute Risk Reduction [ARR]=5.9%; number needed to treat [NNT]=17) and a 41% reduction in total (first plus subsequent) events (P <0.0001) compared with placebo. The risk for the key secondary composite endpoint, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was reduced by 20% (P=0.05) and there was a 27% reduction in fatal/nonfatal myocardial infarction (P=0.03), 47% reduction in urgent/emergent revascularization (P <0.0001) and 58% reduction in hospitalization for unstable angina (P <0.0001). Non-statistically significant reductions were observed in cardiac arrest (44%) and sudden cardiac death (34%).