New analyses showed risk reductions were consistent across age groups for cardiovascular (CV) outcomes, including CV death, with Jardiance® (empagliflozin) compared with placebo when added to standard of care in adults with type 2 diabetes (T2D) and established CV disease. These data, which were presented at the American Diabetes Association (ADA) 76th Scientific Sessions in New Orleans, are from the Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) EMPA-REG OUTCOME® trial.
“As people with type 2 diabetes age, their risk for cardiovascular events increases,” said lead investigator of the trial Bernard Zinman, M.D., director, Diabetes Centre, Mount Sinai Hospital; senior scientist, Lunenfeld Tanenbaum Research Institute, and professor of medicine, University of Toronto, Canada. “These sub-analyses suggest that empagliflozin is associated with reducing cardiovascular events regardless of age when starting treatment. These data provide additional information about the EMPA-REG OUTCOME trial.”
Data presented at the ADA Scientific Sessions examined the effect of treatment with JARDIANCE by age in the EMPA-REG OUTCOME trial. Trial participants were grouped based on their age at baseline: under 65 years, from 65 to 74, and 75 years and older. Consistent reduction in the risk of CV death was seen independent of age groups. Further analysis demonstrated similar consistency by age group in reducing risk for hospitalization for heart failure, as well as for the combination of hospitalization for heart failure or CV death.
Adverse events were consistent with the known safety profile of JARDIANCE. Furthermore, the reduction in risk for CV events did not differ among sub-groups of adults in the EMPA-REG OUTCOME trial based on their LDL (“bad”) cholesterol levels at baseline (<70 mg/dL; 70-<85 mg/dL; 85-<100 mg/dL; 100-115 mg/dL; and >115 mg/dL). The risk reduction with JARDIANCE was consistent across the LDL sub-groups (indicated by a lack of statistical interaction by sub-group) for the combination of CV death, non-fatal heart attack or non-fatal stroke, as well as for the individual outcomes of CV death, hospitalization for heart failure and death from any cause.
“These analyses from the landmark EMPA-REG OUTCOME trial further demonstrate that JARDIANCE reduced the risk of cardiovascular death and hospitalization for heart failure in adults with type 2 diabetes,” said Professor Hans-Juergen Woerle, global vice president medicine, Boehringer Ingelheim. “Through our ongoing research, the BI-Lilly Diabetes alliance is proud to continue to advance the understanding of how to improve the management of cardiovascular risk in this population.”
Filed Under: Drug Discovery