The U.S. Food and Drug Administration [FDA] today approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease. Jardiance is marketed by Boehringer Ingelheim and Eli Lilly and Company. Risk of cardiovascular death is 70 percent higher in adults with diabetes compared to those without, per the Centers for Disease Control and Prevention. It is also the leading cause of death among adults with type 2 diabetes.
Jardiance had already been approved in 2014 for lowering blood sugar in adults with type 2 diabetes, but the FDA said that the drug was also “shown to reduce the risk of cardiovascular death.” Therefore, Jardiance was immediately put into a new clinical trial to prove its effectiveness for cardiovascular disease.
The approval is based on breakthrough evidence from the landmark EMPA-REG OUTCOME trial, which investigated the effects of Jardiance compared with placebo when added to standard of care type 2 diabetes and cardiovascular medicines in adults with type 2 diabetes and established cardiovascular disease. In the trial, Jardiance significantly reduced the risk of the combined primary endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo; absolute risk reduction was 1.6 percent for Jardiance versus placebo. This primary finding was driven by a significant 38 percent reduction in the risk of cardiovascular death; absolute risk reduction was 2.2 percent for patients taking Jardiance versus placebo. There was no change in the risk of non-fatal heart attack or non-fatal stroke. The cardiovascular benefits of Jardiance were consistent among patient subgroups.