Boehringer Ingelheim and Eli Lilly have presented positive top-line results of Jardiance (empagliflozin) from the EMPA-REG OUTCOME study in type 2 diabetes patients at high risk of cardiovascular (CV) events.
According to the firm, the study met its primary endpoint and showed superiority of Jardiance, when added to standard of care in CV 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 claimed to be the only glucose-lowering agent that has demonstrated CV risk reduction in a dedicated cardiovascular outcomes trial.
Boehringer Ingelheim medicine global vice president professor Hans-Juergen Woerle said: "The cardiovascular risk reduction Jardiance demonstrated in the EMPA-REG OUTCOME trial is exciting and we look forward to sharing the full results."
"Approximately 50% of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease. Reducing cardiovascular risk is an essential component of diabetes management."
EMPA-REG OUTCOME is a multicentre, randomised, double-blind, and placebo-controlled study, which included approximately 7,000 individuals from 42 countries and observed for a median duration of 3.1 years.
The company has designed the study to evaluate the effect of Jardiance, including 10mg or 25mg once daily, added to standard of care compared with placebo on CV events in adults with T2D, at high risk of CV events and with less than optimised blood glucose control.