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 (NYSE:LLY), were published in The Lancet Diabetes & Endocrinology.
"People with type 2 diabetes and established atherosclerotic cardiovascular disease are at an increased risk of cardiovascular complications often requiring recurrent admissions to hospital, imposing a significant burden on quality of life for patients and on healthcare systems," said Darren McGuire, M.D., M.H.Sc., lead author of the analysis and Professor of Medicine at the University of Texas Southwestern Medical Center and Parkland Health and Hospital System. "Considering the totality of hospitalization events, as opposed to just the first event that is most commonly analyzed in clinical trials, better reflects the net effect of beneficial therapies. These new findings help us understand the impact of long-term treatment with Jardiance for adults who may experience recurrent events due to these debilitating conditions."
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%.
"These new results support the early and sustained cardiovascular benefits for Jardiance noted previously throughout the three-year EMPA-REG OUTCOME trial," said Mohamed Eid, M.D., M.P.H, M.H.A, vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. "Reducing risk beyond the first event for important heart-related outcomes is critical for people living with type 2 diabetes and established cardiovascular disease, which are complicated, life-long conditions."
"Boehringer Ingelheim and Lilly will continue to explore how Jardiance can potentially improve health outcomes and fill treatment gaps for adults with type 2 diabetes and heart disease," said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly. "We look forward to presenting further results from our EMPOWER program, which is one of the largest cardiovascular clinical programs for an SGLT2 inhibitor to date with more than 377,000 adults studied worldwide."