Primary CV outcomes endpoint met by SGLT2 inhibitor in type 2 diabetes


News - Aug. 20, 2015

The long-term clinical EMPA-REG OUTCOME trial investigating cardiovascular (CV) outcomes for empagliflozin in more than 7,000 adults with type 2 diabetes (T2D) at high risk for CV event met its primary endpoint (time to first occurrence of either CV death, or non-fatal myocardial infarction or non-fatal stroke). Superiority of empagliflozin, when added to standard of care, was demonstrated in CV risk reduction.

Empagliflozin is a potent and selective sodium glucose cotransporter 2 (SGLT2) inhibitor. Empagliflozin is the only glucose-lowering agent to have demonstrated CV risk reduction in a dedicated cardiovascular outcomes trial.

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 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).

“The cardiovascular risk reduction empagliflozin 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 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 empagliflozin was consistent with previous studies. Detailed study results will be presented on 17 September at the 51st European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden.
 Press release Boehringer Ingelheim, August 20, 2015

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