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Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company's (NYSE: LLY) Jardiance® (empagliflozin) significantly reduced the risk of the combined endpoint of cardiovascular (CV) death, non-fatal heart attack or non-fatal stroke by 14 percent when added to standard of care in patients with type 2 diabetes (T2D) at high risk of CV events. There was a 38 percent reduction in CV death, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke.
In addition, treatment with JARDIANCE resulted in a lower risk of all-cause mortality (32 percent reduction) and hospitalization for heart failure (35 percent reduction).
"These results are both novel and exciting for the millions of people living with type 2 diabetes at risk for cardiovascular disease. Addressing the burden of cardiovascular events, including death, is at the core of diabetes care, and until now no single diabetes medication has been associated with a reduction in mortality," said lead investigator of the trial Bernard Zinman, M.D., Director, Diabetes Centre, Mount Sinai Hospital; Senior Scientist, Lunenfeld Tanenbaum Research Institute, and Professor of Medicine, University of Toronto, Canada. "In this study, empagliflozin was shown to prevent one out of three cardiovascular deaths."
Life expectancy of people with T2D at high CV risk is, on average, decreased by up to 12 years with approximately 50 percent of deaths in people with T2D caused by CV disease. The effect of JARDIANCE in this trial was observed on top of standard of care. This means the benefit was seen over and above other treatments patients were already receiving for diabetes and/or cardiovascular disease (such as blood pressure and cholesterol lowering-medications).
"The EMPA-REG OUTCOME trial results are encouraging for healthcare professionals and their patients," said Christopher P. Cannon, M.D., Cardiovascular Division, Brigham and Women's Hospital and Professor of Medicine, Harvard Medical School, who was not involved in the study. "Patients in the study were already being treated with medications that have been proven to reduce cardiovascular events. The observation that empagliflozin provided additional cardiovascular death reduction on top of these other medications is a very important finding."
The overall safety profile of JARDIANCE was consistent with previous trials. The incidence of diabetic ketoacidosis was at or below 0.1 percent and similar across all treatment groups.
These data were presented today at the 51st European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden, and simultaneously published in the New England Journal of Medicine.
"The Boehringer Ingelheim and Lilly Diabetes Alliance is very pleased to share the results of the EMPA-REG OUTCOME trial with the healthcare community," said Prof. Hans-Juergen Woerle, Global Vice President Medicine, Boehringer Ingelheim. "Cardiovascular disease is the number one cause of death in people with type 2 diabetes worldwide and reducing cardiovascular risk, including death, is an essential component of diabetes management."
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