New sub-analysis data presented showed the reduction in risk for hospitalisation for heart failure or cardiovascular death with Jardiance (empagliflozin) compared with placebo when added to standard of care in patients with type 2 diabetes (T2D) at high risk of cardiovascular (CV) events was consistent across all sub-groups analysed, including those who had heart failure at baseline and those who did not. These results were presented on behalf of Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company at the 2015 scientific sessions of the American Heart Association in Orlando, Florida. The data were part of a pre-specified analysis of secondary endpoints of the landmark EMPA-REG OUTCOME trial.

"Cardiovascular disease, including heart failure, is the leading cause of death associated with diabetes," said Silvio Inzucchi, M.D., professor of medicine, Yale School of Medicine.

"People with diabetes are two- to three-times more likely to develop heart failure than those individuals without diabetes. We need treatments that can help reduce the high rates of heart failure—and the resulting hospitalisations and deaths—in this population."

New data also presented demonstrate Jardiance reduced the risk of the composite endpoint of rates of hospitalization for heart failure or death from heart failure by 39 per cent compared with placebo when added to standard of care in patients with T2D at high risk of CV events.

"To date, no glucose-lowering medication has been shown to reduce the risk of hospitalisation for heart failure or death from heart failure in a cardiovascular outcomes study," said Prof. Hans-Juergen Woerle, global vice president medicine, Boehringer Ingelheim.

"These results with Jardiance show the importance of continuing to advance research that will help our understanding of how to manage and mitigate the risk of cardiovascular disease in people with type 2 diabetes."

EMPA-REG OUTCOME was a long-term, multicenter, randomized, double-blind, placebo-controlled trial of more than 7,000 patients from 42 countries with T2D at high risk for CV events.

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 CV drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of CV death, non-fatal heart attack or non-fatal stroke.

Over a median of 3.1 years, Jardiance significantly reduced the risk of CV death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo. Risk of CV death was reduced by 38 per cent, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke. Treatment with Jardiance also resulted in a 32 per cent reduced risk of all-cause mortality and a 35 percent reduced risk of hospitalisation for heart failure.

The overall safety profile of Jardiance was consistent with that of previous trials. The incidence of diabetic ketoacidosis was at or below 0.1 per cent and similar across all treatment groups.

Approximately 29 million Americans and an estimated 387 million people worldwide have type 1 or type 2 diabetes, and nearly 28 per cent of Americans with diabetes—totaling 8 million people—are undiagnosed. In the US, approximately 12 per cent of those aged 20 and older have diabetes. T2D is the most common type, accounting for an estimated 90 to 95 per cent of all diagnosed adult diabetes cases in the US. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.