The Food and Drug Administration (FDA) has approved supplemental New Drug Applications (sNDAs) for three empagliflozin-containing drugs to include data from the EMPA-REG OUTCOME trial.
The labeling for Boehringer Ingelheim and Lilly‘s Synjardy (empagliflozin/metformin HCl), Synjardy XR (empagliflozin/metformin HCl extended-release), and Glyxambi (empagliflozin/linagliptin) tablets has been updated with data showing that empagliflozin reduced the risk of cardiovascular death vs. placebo when added to standard of care type 2 diabetes and cardiovascular medicine in adults with type 2 diabetes and established cardiovascular disease.
In the EMPA-REG OUTCOME trial, empagliflozin significantly reduced the relative risk of the composite primary endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14% vs. placebo (hazard ratio [HR] 0.86, 95% CI: 0.74–0.99) in adults with type 2 diabetes and established cardiovascular disease. The absolute risk reduction was 1.6% for empagliflozin vs. placebo. The study reported a significant 38% reduction in the relative risk of cardiovascular death (HR 0.62, 95% CI: 0.49–0.77) and a 2.2% reduction in absolute risk for empagliflozin treated patients vs. placebo.
No change in the risk of non-fatal heart attack (HR 0.87, 95% CI: 0.70–1.09) or non-fatal stroke (HR 1.24, 95% CI: 0.92–1.67) was noted in the study. The cardiovascular benefits of empagliflozin were similar among patient subgroups.
All three antidiabetic agents are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. While empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, the efficacy of Synjardy, Synjardy XR, and Glyxambi on reducing the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease has not been established.