Amarin announces new REDUCE-IT data at ACC.23/WCC

Amarin announced a new analysis from the VASCEPA/VAZKEPA cardiovascular outcomes REDUCE-IT study showing the effectiveness of VASCEPA/VAZKEPA in patients with recent acute coronary syndrome. This post-hoc analysis showed that icosapent ethyl substantially and significantly reduced the risk of first and total ischemic events by 37% and 36% respectively in patients with recent acute coronary syndrome without increasing bleeding, supporting early initiation of IPE after ACS. The data were presented at the American College of Cardiology’s 72nd Annual Scientific Session together with the World Heart Federation’s World Congress of Cardiology in New Orleans, LA. In this post hoc ACS analysis of the landmark REDUCE-IT study, 840 patients who experienced recent ACS, defined as myocardial infarction or unstable angina less than12 months before randomization were compared to 3,651 patients with ACS greater than or equal to12 months before randomization to assess the efficacy of VASCEPA/VAZKEPA on first and total primary events endpoints. The absolute risk reduction for first events with IPE treatment over 5 years for the primary composite endpoint was 9.3% with a number needed to treat of 11. The absolute risk reduction for first events with IPE treatment in patients with ACS greater than or equal to12 months was 4.7% with an NNT of 21. Overall tolerability and adverse event patterns with IPE and placebo in patients with recent ACS were consistent with the full study. Bleeding event rates were no more frequent with IPE than placebo despite extensive use of dual antiplatelet therapy. Limitations include that REDUCE-IT was not powered for multiple subgroup analyses, and this was a post hoc defined subset among post ACS patients.