Jardiance reduced the risk of first plus recurrent cardiovascular events in type 2 diabetes and CV disease in a new analysis from the EMPA-REG OUTCOME trial.- Eli Lilly

Jardiance (empagliflozin) reduced the risk of total (first plus recurrent) cardiovascular events compared with placebo, when both were given on top of standard of care, in adults with type 2 diabetes and established cardiovascular disease over the three years of the EMPA-REG OUTCOME trial, according to results of a new post-hoc analysis. Total cardiovascular events included 3P-MACE (a composite of non-fatal heart attack, non-fatal stroke and cardiovascular death), hospitalization for heart failure and all-cause hospitalization. The findings, announced by Boehringer Ingelheim and Eli Lilly and Company and were published in The Lancet Diabetes & Endocrinology. Previously, the landmark EMPA-REG OUTCOME trial showed that, in adults with type 2 diabetes and established cardiovascular disease, Jardiance reduced the relative risk of 3P-MACE by 14%, driven by a 38% reduction in the relative risk of cardiovascular death. These new exploratory analyses show that, when added to standard of care, Jardiance reduced the relative risk of the following total (first plus recurrent) events versus placebo:3P-MACE by 22%. Hospitalizations for heart failure by 42%. All-cause hospitalizations by 17%. Fatal or non-fatal myocardial infarction, commonly known as heart attack, by 21%. Coronary heart disease events (a composite of myocardial infarction and coronary revascularization) by 20%. About EMPA-REG OUTCOME (NCT01131676): EMPA-REG OUTCOME was a long-term, multicenter, randomized, double-blind, placebo-controlled trial of more than 7,000 patients from 42 countries with type 2 diabetes and established cardiovascular disease. The study assessed the effect of Jardiance (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care. Standard of care was comprised of glucose-lowering agents and cardiovascular drugs (including medication for the treatment of hypertension and hypercholesteremia). The primary endpoint was defined as time to first occurrence of cardiovascular death, non-fatal heart attack or non-fatal stroke.The overall safety profile of Jardiance was consistent with that of previous trials. About the EMPOWER Program : The Alliance has developed the EMPOWER program to explore the impact of Jardiance on major clinical cardiovascular and renal outcomes in a spectrum of cardio-renal-metabolic conditions. Cardio-renal-metabolic conditions are the leading cause of mortality worldwide and account for up to 20 million deaths annually. Through the EMPOWER program, Boehringer Ingelheim and Lilly are working to advance knowledge of these interconnected systems and create care which offers integrated, multi-organ benefits. Comprised of nine clinical trials and two real-world evidence studies, EMPOWER reinforces the long-term commitment of the Alliance to improve outcomes for people living with cardio-renal-metabolic conditions. With more than 377,000 adults estimated to have enrolled worldwide upon completion of the studies, it is one of the broadest and most comprehensive clinical programs for an SGLT2 inhibitor to date. See- "Effects of empagliflozin on first and recurrent clinical events in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a secondary analysis of the EMPA-REG OUTCOME trial."- Darren K McGuire, Bernard Zinman, Silvio E Inzucchi, Christoph Wanner, David Fitchett, Stefan D Anker, and others.The Lancet Diabetes & Endocrinology, Vol. 8, No. 12, p949–959 Published: December, 2020. See- "EMPA-REG OUTCOME and beyond: the long game of cardiovascular risk reduction".- Vanita R Aroda, Marc S Sabatine The Lancet Diabetes & Endocrinology, Vol. 8, No. 12, p932–933 Published: December, 2020.