256-OR: Substantial Cardiovascular Risk Reduction with Icosapent Ethyl Regardless of Diabetes Status or BMI: REDUCE-IT BMI

Background: REDUCE-IT, a multinational, double-blind trial, randomized 8179 statin-treated patients with controlled low density lipoprotein cholesterol, elevated triglycerides, and cardiovascular (CV) risk, to icosapent ethyl (IPE) 4 grams daily or placebo. IPE reduced the primary (CV death, myocardial infarction [MI], stroke, coronary revascularization, hospitalization for unstable angina) and key secondary (CV death, MI, stroke) endpoints 25% and 26%, respectively (each p Methods: We evaluated if BMI modulated CV risk reduction with IPE in patients with or without DM. Results: In the full cohort, similar CV risk reduction was observed across the prespecified endpoint testing hierarchy (interaction p=ns for all), and relative safety between treatment groups was generally consistent. In persons with or without DM, similar reductions in the primary endpoint were observed across BMI categories (Figure), with similar findings in the key secondary endpoint (interaction p=ns for all). Conclusion: The significant cardiovascular risk reduction provided by IPE 4g/day is consistent across BMI in patients with and without DM. Disclosure D. L. Bhatt: Research Support; Self; Afimmune Limited, Amarin Corporation plc, Amgen Inc., AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly and Company, Idorsia Pharmaceuticals Ltd, Lexicon Pharmaceuticals, Inc., PLx Pharma Inc., Sanofi-Aventis. C. M. Ballantyne: Advisory Panel; Self; Amarin Corporation plc, Arrowhead Pharmaceuticals, Inc., Pfizer Inc., Consultant; Self; Amgen Inc., CSL Behring, Intercept Pharmaceuticals, Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Regeneron Pharmaceuticals Inc., Research Support; Self; Abbott, Amgen Inc., Ionis Pharmaceuticals, Novartis Pharmaceuticals Corporation, Regeneron Pharmaceuticals Inc., Roche Diagnostic USA. E. A. Brinton: Consultant; Self; 89bio, Inc., DalCor Pharmaceuticals, Esperion, Novartis AG, Other Relationship; Self; Kowa Pharmaceuticals America, Inc., Speaker’s Bureau; Self; Aegerion Pharmaceuticals Inc., Amarin Corporation plc, Amgen Inc., Esperion, Medicure. P. G. Steg: Consultant; Self; Amarin Corporation plc, Amgen Inc., AstraZeneca, Bristol-Myers Squibb Company, Novartis Pharmaceuticals Corporation, Research Support; Self; Bayer AG, Sanofi, Servier Laboratories. S. B. Ketchum: Employee; Self; Amarin Corporation plc, Stock/Shareholder; Self; Amarin Corporation plc. R. A. Juliano: Employee; Self; Amarin Corporation plc, Stock/Shareholder; Self; Amarin Corporation plc. L. Jiao: Employee; Self; Amarin Corporation plc, Stock/Shareholder; Self; Amarin Corporation plc. R. T. Doyle: Employee; Self; Amarin Corporation plc, Stock/Shareholder; Self; Amarin Corporation plc. C. Granowitz: Employee; Self; Amarin Corporation plc. J. Tardif: Other Relationship; Self; Amarin Corporation plc, DalCor Pharmaceuticals, DalCor Pharmaceuticals, Sanofi, Research Support; Self; AstraZeneca, Ceapro, DalCor Pharmaceuticals, Esperion, REGENXBIO Inc., Servier Laboratories.