In the EMPA-REG OUTCOME trial CV death was part of the composite primary endpoint (3-point MACE); hospitalization for heart failure was a key secondary, all-cause mortality was an exploratory outcome.
Empagliflozin has an FDA indication since December 2016 to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease. Effect of empagliflozin on cardiovascular events is included in the 5.1. section of Jardiance EU SmPC (Jan 2017).
Video with interviews and animations - 7:43 min
