Researchers considered finding a diabetes drug that also produced a cardiovascular benefit to be a "holy grail."
Today, the FDA approved a new indication for empagliflozin, sold as Jardiance, to reduce the risk of cardiovascular (CV) death for adults with type 2 diabetes (T2D). This marks the first time a diabetes drug has received this indication.
The new indication sets Jardiance apart from its competitors among sodium glucose cotransporter-2 (SGLT2) inhibitors more than a year after the CV benefits of the drug were found in the EMPA-REG OUTCOME study, and presented in Stockholm, Sweden. In that trial, which involved 7000 patients, Jardiance was found to reduce the risk of CV death, compared to a placebo, when added to standard of care therapies for diabetes and atherosclerotic CV disease.
Thus, Jardiance was the first diabetes drug to show a CV benefit in high-risk patients, which researchers considered a “holy grail” The safety trial that uncovered the benefit, in fact, was the result of findings a decade prior in which an earlier blockbuster class of diabetes drugs were found to have potential risks, which caused the FDA to change its approval process to require postmarketing cardiovascular outcomes trials.
“Cardiovascular disease is a leading cause of death in adults with type 2 diabetes mellitus,” said Jean-Marc Guettier, MD, CM, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Availability of antidiabetes therapies that can help people live longer by reducing the risk of cardiovascular death is an important advance for adults with type 2 diabetes.”
The CDC reports that death from CV disease is 70% higher among those with diabetes than those without, and just this week, a journal of the American College of Cardiology reported that, among the 3 main risk factors—the other 2 being hypertension and obesity—those who have diabetes by age 45 face the greatest increase in risk of dying from heart failure.
SGLT2 inhibitors work through a distinct mechanism of action in which excess glucose is expelled from the body through the urinary tract. The drug class is known to have positive effects on hypertension and may produce modest weight loss. SGLT2 inhibitors are only approved for use in T2D, but they are being studied in patients with type 1 diabetes.
Jardiance is distributed by Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, Connecticut.