Empagliflozin (Jardiance) has been proven to ‘significantly’ reduce cardiovascular risk in patients with diabetes, data from a dedicated trial has revealed.
The study data, taken from the EMPA-REG OUTCOME trial, found that empagliflozin reduced the risk of cardiovascular (CV) death, non-fatal heart attack or non-fatal stroke by 14% in patients with type 2 diabetes when compared to placebo. There was a ‘significant’ 38% risk reduction in CV death, with no significant difference in the risk reduction of non-fatal heart attack or non-fatal stroke.
Additionally, empagliflozin resulted in a risk reduction of all-cause mortality of 32% and hospitalisation for heart failure of 35%.
Patients with type 2 diabetes have a two to four fold increased risk of CV events, and about half of all patients with type 2 diabetes will die from CV disease. Diabetes can reduce life expectancy by up to 12 years in patients at high CV risk. The effect of empagliflozin in this trial was observed on top of standard care, meaning the benefit was seen over and above other treatments patients were already receiving for diabetes and/or cardiovascular disease. For example, three in four were on statins and more than nine in 10 were on blood pressure medications.
The overall safety profile of empagliflozin was consistent with previous trials. The incidence of diabetic ketoacidosis in patients was below 0.1% and similar across all treatment groups.
“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.”
Professor Klaus Dugi, Boehringer Ingelheim Medical Director, UK and Ireland, added: “In total there are currently over 3.3 million people with diabetes in the UK. Every day a further 700 people are diagnosed. They will face many challenges. However, what often goes unreported is that it is cardiovascular events that are the number one cause of death. Reducing cardiovascular risk is therefore an essential component of diabetes management.
“We believe that this trial data could be one of the significant advances in diabetes care comparable perhaps to the introduction of insulin by Eli Lilly over 90 years ago.”
The data was 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.