Additional Data from EMPA-REG OUTCOME Announced

A total of 7,020 took part in the trial and were randomized 1:1:1 to a once-daily empagliflozin 10mg, 25mg, or placebo
A total of 7,020 took part in the trial and were randomized 1:1:1 to a once-daily empagliflozin 10mg, 25mg, or placebo

According to new analyses from the EMPA-REG OUTCOME trial, empagliflozin reduced the risk of cardiovascular (CV) death in patients with type 2 diabetes (T2D) and established CV disease independent of blood glucose levels at baseline. The findings were presented at the European Association for the Study of Diabetes (EASD) 53rd Annual

Empagliflozin (Jardiance; Boehringer Ingelheim and Lilly)—initially approved as adjunct to diet and exercise to improve glycemic control in adults with T2D— was the first treatment to be granted the additional indication last year for reducing the risk of cardiovascular death in adults with T2D. 

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Participants in the multi-national trial fell into 1 of 4 blood sugar levels at the start of the study; A1C levels of <7%, 7%–<8%, 8%–<9%, and ≥9%. Results demonstrated that the risk of cardiovascular death was lowered in all groups compared with placebo and was found to be consistent with the risk reduction in the overall trial population. Furthermore, this risk reduction was maintained regardless of whether blood sugar control was improved after the introduction of empagliflozin, while side effects were similar between both treatment groups.

When empagliflozin was added to metformin or sulfonylurea, the cardiovascular death reduction, compared to placebo, was consistent with the overall trial population.

"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, MD, professor of medicine at 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."

For more information visit EASD.org.