New analyses of the landmark EMPA-REG OUTCOME trial showed that Jardiance (empagliflozin) tablets reduced the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, independent of blood sugar control at the start of the study. A reduction in cardiovascular death was also seen when Jardiance was added to common first and second-line diabetes medications, such as metformin or sulfonylurea. These results from post-hoc analyses were presented by Boehringer Ingelheim and Eli Lilly and Company at the 53rd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Lisbon, Portugal.

"Now that we have a new option for reducing the risk of cardiovascular death among adults with type 2 diabetes, we are striving to better understand if there are differences in how adults with type 2 diabetes can benefit," said Silvio Inzucchi, M.D., professor of medicine, Yale School of Medicine, who presented the data today. "These new analyses of the EMPA-REG OUTCOME trial showed empagliflozin was effective in reducing the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, no matter what the blood sugar levels at the start of the study were or if empagliflozin was added to commonly used oral blood sugar lowering treatments."

In all four blood sugar level groups at study start (A1C levels of < 7.0 percent, 7.0 percent to < 8.0 percent, 8.0 percent to < 9.0 percent and =9.0 percent), patients receiving Jardiance demonstrated a reduction in the risk of cardiovascular death compared with placebo. This was consistent with the risk reduction seen in the overall trial population and seen irrespective of whether blood sugar control was improved following introduction of the study treatment (as measured by a decrease in A1C level of = 0.5 percent at week 12).

Additional post-hoc analyses showed that when Jardiance was added to metformin or sulfonylurea, the reduction of cardiovascular death compared with placebo was consistent with the overall trial population. These analyses also showed the proportion of patients with hypoglycemic side effects were similar between the placebo and Jardiance groups in the EMPA-REG OUTCOME trial.

Jardiance is the first and only oral type 2 diabetes medicine approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. The landmark EMPA-REG OUTCOME trial demonstrated that Jardiance reduced the risk of cardiovascular death by 38 percent versus placebo in people with type 2 diabetes and established cardiovascular disease when added to standard of care (including glucose-lowering agents and cardiovascular drugs). The overall safety profile of Jardiance in EMPA-REG OUTCOME was consistent with that of previous studies of Jardiance and current label information.

"Cardiovascular disease remains the leading cause of death in people with type 2 diabetes and contributes significantly to the burden of diabetes care," said David Kendall, M.D., distinguished medical fellow, Lilly Diabetes. "The results presented at EASD add further evidence of the benefit Jardiance can provide to adults with type 2 diabetes with different background blood sugar control."

"Boehringer Ingelheim and Lilly are committed to advancing the understanding of the EMPA-REG OUTCOME data to help physicians better tailor their treatment approach, since proper type 2 diabetes management requires a personalized plan," said Rogelio Braceras, M.D., therapeutic area head, Clinical Development & Medical Affairs, Metabolism, Boehringer Ingelheim Pharmaceuticals, Inc. "We're pleased that Jardiance's life-saving cardiovascular benefit to reduce the risk of cardiovascular death was consistent in the trial regardless of the baseline variables we tested, including blood sugar levels."