The FDA has approved supplemental New Drug Applications for three type 2 diabetes medicines within the empagliflozin family to include data from the EMPA-REG OUTCOME trial.

The data show that empagliflozin reduced the risk for cardiovascular death 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. The data have been added to the Prescribing Information for Synjardy (empagliflozin/metformin hydrochloride), Synjardy XR (empagliflozin/metformin hydrochloride extended-release), and Glyxambi (empagliflozin/linagliptin) tablets.

In EMPA-REG OUTCOME, empagliflozin significantly reduced the relative risk of the combined primary endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14% compared with placebo. Absolute risk reduction was 1.6% for empagliflozin vs placebo. There was a 38% reduction in the relative risk of cardiovascular death. Absolute risk reduction was 2.2% for patients taking empagliflozin vs placebo.