Jardiance Reduces Mortality Risk for Patients with Diabetes

New data suggest that empagliflozin (Jardiance) may reduce the risk of cardiovascular death when added to standard care among patients with type 2 diabetes and peripheral artery disease, according to a press release.

The post-hoc analysis of the EMPA-REG OUTCOME clinical trial were presented at the American Heart Association (AHA) Scientific Sessions 2017 and published in Circulation.

“Peripheral artery disease, one of the most common cardiovascular complications associated with type 2 diabetes, increases the risk of death from cardiovascular causes,” said Subodh Verma, MD. “There is an urgent need for treatment options that can improve cardiovascular-related outcomes in people with type 2 diabetes and peripheral artery disease.”

Approximately 1 in 3 patients with diabetes also have peripheral artery disease, which is characterized by a narrowing of the arteries outside of the heart due to plaque build-up. The condition can be fatal when blockages restrict circulation, which causes damage to the limbs and vital organs, according to Boehringer Ingelheim. Patients with poorly-controlled peripheral artery disease may also require amputation.

Included in the EMPA-REG OUTCOME trial were more than 7000 patients, 21% of whom had existing peripheral artery disease.

An analysis of patients with peripheral artery disease revealed that treatment with empagliflozin reduced the risk of cardiovascular mortality by 43% compared with placebo, according to the study. The authors also found that all-cause mortality was reduced by 38% compared with placebo.

Additionally, the endpoint of cardiovascular death, non-fatal heart attack, or non-fatal stroke was lowered by 16% among patients receiving empagliflozin.

Notably, new or worsening kidney disease plummeted 46%, which is a significant improvement, according to the study.

Overall, the authors found that side effects were similar between the treatment and placebo cohorts. Of patients with peripheral artery disease, lower-limb amputations occurred in 5.5% of patients receiving empagliflozin and 6.3% of patients receiving placebo, according to the release.

Currently, empagliflozin is the only oral type 2 diabetes drug approved to lower the risk of cardiovascular death among patients with diabetes and heart disease, according to Boehringer Ingelheim.

“Through ongoing sub-analyses of the EMPA-REG OUTCOME data, we are gaining a better understanding of how Jardiance may help a wide range of people living with type 2 diabetes and its complications,” said Rogelio Braceras, MD, therapeutic area head, Clinical Development & Medical Affairs, Metabolism, Boehringer Ingelheim Pharmaceuticals, Inc. “The data presented and published at the AHA Scientific Sessions showed that Jardiance reduced the risk for cardiovascular death and kidney disease in this highly vulnerable population of people with type 2 diabetes and peripheral artery disease.”