Top-line study results demonstrated that Eli Lilly and Boehringer Ingelheim's Jardiance (empagliflozin) was superior to placebo in cardiovascular (CV) risk reduction in adults with type 2 diabetes at high risk for CV events, the companies announced Thursday. Eli Lilly and Boehringer Ingelheim said that Jardiance "is the only glucose-lowering agent to have demonstrated CV risk reduction in a dedicated cardiovascular outcomes trial."
The EMPA-REG OUTCOME study randomised more than 7000 people with type 2 diabetes at high risk of CV events and with less than optimised blood glucose control to treatment with Jardiance or placebo, both in addition to standard of care. The main goal of the trial was the time to first occurrence of CV death, non-fatal myocardial infarction or non-fatal stroke. Eli Lilly and Boehringer Ingelheim noted that the trial was designed to first test for non-superiority followed by superiority.
Hans-Juergen Woerle, global vice president of medicine at Boehringer Ingelheim, remarked "the [CV] risk reduction Jardiance demonstrated...is exciting and we look forward to sharing the full results." The drugmakers said that detailed study results will be presented next month at the upcoming annual meeting of the European Association for the Study of Diabetes.
Jardiance was co-developed by Eli Lilly and Boehringer Ingelheim under the terms of a 2011 agreement that was amended last year. The therapy was cleared by the FDA in 2014 for use as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes after being approved for the treatment of type 2 diabetes in Europe earlier that year.
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