Boehringer Ingelheim, one of the world’s 20 leading pharmaceutical companies, and Eli Lilly and Company, a global healthcare leader, announced positive top-line results from EMPA-REG Outcome, 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 professor Hans-Juergen Woerle, global vice president medicine, Boehringer Ingelheim.
“Approximately 50 per cent of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease. Reducing cardiovascular risk is an essential component of diabetes management,” he added.
The safety profile of Jardiance was consistent with previous studies. Detailed study results will be presented on September 17 at the 51st European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden.
EMPA-REG Outcome was a multicentre, randomised, 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 (empagliflozin) (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 optimised blood glucose control. The study was designed to first test for non-inferiority and then for superiority.
Standard of care comprised glucose lowering agents and cardiovascular drugs (including antihypertensive and lipid lowering agents).
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centres on compounds representing several of the largest diabetes treatment classes.