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.  

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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. 

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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. 

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