Jardiance® demonstrated cardiovascular (CV) risk reduction in people with type 2 diabetes at high risk for CV events

RIDGEFIELD, Conn and INDIANAPOLIS, Boehringer Ingelheim and Eli Lilly and Company today announced positive top-line results from EMPA-REG OUTCOME^®. This is a long-term clinical trial investigating cardiovascular (CV) outcomes for Jardiance^® (empagliflozin) in more than 7,000 adults with type 2 diabetes (T2D) at high risk for CV events. EMPA-REG OUTCOME met its primary endpoint and demonstrated superiority of JARDIANCE, when added to standard of care, in CV risk reduction. The primary endpoint was defined as time to first occurrence of either CV death, or non-fatal myocardial infarction or non-fatal stroke.

JARDIANCE is the only glucose-lowering agent to have demonstrated CV risk reduction in a dedicated cardiovascular outcomes trial.

"The cardiovascular risk reduction JARDIANCE demonstrated in the EMPA-REG OUTCOME trial is exciting and we look forward to sharing the full results," said Prof. Hans-Juergen Woerle, global vice president medicine, Boehringer Ingelheim. "Approximately 50 percent of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease. Reducing cardiovascular risk is an essential component of diabetes management."

The safety profile of JARDIANCE was consistent with previous studies. Detailed study results will be presented on September 17 at the 51^st European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden.

About the Study  
EMPA-REG OUTCOME was a multicenter, randomized, double-blind, placebo-controlled trial that involved more than 7,000 individuals from 42 countries observed for a median duration 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 on CV events in adults with T2D at high risk of CV events and with less than optimized blood glucose control. 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 antihypertensive and lipid lowering agents).

About JARDIANCE 
JARDIANCE is a once-daily pill taken in the morning, used along with diet and exercise, to lower blood sugar (A1C) in adults with type 2 diabetes. JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

Source:  Eli Lilly and Company; Boehringer Ingelheim Pharmaceuticals, Inc.