Boehringer Ingelheim, one of the world’s 20 leading pharmaceutical companies, and Eli Lilly and Company’s Jardiance (empagliflozin) significantly reduced the risk of the combined endpoint of cardiovascular (CV) death, non-fatal heart attack or non-fatal stroke by 14 per cent when added to standard of care, in patients with type 2 diabetes (T2D) at high risk of CV events. There was a 38 per cent 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 per cent reduction) and hospitalisation for heart failure (35 per cent 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 Dr. Bernard Zinman, 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 twelve years with approximately 50 per cent 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 Dr. Christopher P. Cannon, 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 per cent and similar across all treatment groups.
These data were presented 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 www.nejm.org.
"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.”
EMPA-REG OUTCOME was a long-term, multicentre, randomised, double-blind, placebo-controlled trial that involved more than 7,000 patients from 42 countries with type 2 diabetes at high risk for cardiovascular events. There were 772 primary outcome events in the EMPA-REG OUTCOME trial over a median observation period of 3.1 years.
The study was designed to assess the effect of Jardiance (10mg or 25mg once daily) added to standard of care compared with placebo added to standard of care. The primary endpoint was defined as time to first occurrence of either CV death, or non-fatal heart attack or non-fatal stroke. The study was designed to first test for non-inferiority and then for superiority.
Standard of care was comprised of glucose-lowering agents and cardiovascular drugs (including blood pressure and cholesterol-lowering medications).
Of the 7,020 treated patients, more than 97 per cent completed the trial and vital status was available for more than 99 per cent of these patients at study end. Analyses and results were independently validated and confirmed by the University of Freiburg, Germany an internationally renowned Academic Centre specializing in statistical analyses.
Jardiance is an oral, once daily, highly selective sodium glucose co-transporter 2 (SGLT2) inhibitor approved for use in Europe, the United States and other markets around the world for the treatment of adults with type 2 diabetes.
Jardiance works by blocking the reabsorption of glucose (blood sugar) by the kidney, leading to urinary glucose excretion, and lowering blood glucose levels in people with type 2 diabetes. SGLT2 inhibition targets glucose directly and works independently of ß-cell function and the insulin pathway.
Jardiance is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).