Jardiance reducea the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease.
The FDA recently approved empagliflozin (Jardiance) to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease, according to a press release.
The approval is based on a postmarketing study, which was required by the agency when Jardiance was approved in 2014 as an adjunct to exercise and diet to improve glycemic control in adults with type 2 diabetes. In the postmarket clinical trial of empagliflozin, more than 7000 patients with type 2 diabetes and cardiovascular disease were enrolled.
The results of the study showed that when empagliflozin was added to standard of care therapies for diabetes and atherosclerotic cardiovascular disease, it reduced the risk of cardiovascular death compared with a placebo.
“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, 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 most common adverse events of empagliflozin are urinary tract infections and female genital infections. Cardiovascular disease-related death is 70% higher in adults with diabetes compared to adults without diabetes, according to the CDC.
Patients with diabetes have a decreased life expectancy driven mostly by premature cardiovascular death.