Amarin announces results from new REDUCE-IT analyses

Amarin 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 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 at the American Heart Association Scientific Sessions 2023, taking place November 11 – 13, 2023 in Philadelphia, PA and simultaneously published in the European Heart Journal Open. Among patients with Metabolic Syndrome but without diabetes at baseline, those who were allocated to icosapent ethyl 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 and a 41% reduction in total events 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% and there was a 27% reduction in fatal/nonfatal myocardial infarction, 47% reduction in urgent/emergent revascularization and 58% reduction in hospitalization for unstable angina. Non-statistically significant reductions were observed in cardiac arrest and sudden cardiac death. The large relative and absolute risk reductions observed supports IPE as an important therapeutic option for patients with metabolic syndrome at high cardiovascular risk, despite lacking robust effects on any metabolic syndrome component. Limitations of these analyses, some of which are exploratory in nature, include the relatively small number of events in certain subgroups or for certain endpoints, such as cardiac arrest and sudden cardiac death. In addition, variation in subjective measures may have affected classification of metabolic syndrome.