New indication approved for empagliflozin

Empagliflozin (Jardiance) is approved for a new indication—to reduce the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease, the FDA announced on Dec. 2.

When the diabetes drug was approved in 2014, the FDA required a postmarketing clinical trial of more than 7,000 patients with type 2 diabetes and cardiovascular disease, according to an FDA press release. In the trial, which was summarized in the October 2015 ACP Diabetes Monthly, empagliflozin reduced the risk of cardiovascular death compared to placebo when added to standard-of-care therapies for diabetes and atherosclerotic cardiovascular disease.

The most common side effects are urinary tract infections and female genital infections, according to an FDA press release. Empagliflozin can cause dehydration, hypotension, ketoacidosis, serious urinary tract infections, acute kidney injury and impairment in renal function, hypoglycemia when used with insulin or insulin secretagogues, genital mycotic infections, and increased cholesterol.