FDA Expands Jardiance Label to Include Adults With Type-2 Diabetes and Cardiovascular Disease

Post-marketing study links treatment to reduced risk of cardiovascular death

The FDA has approved a new indication for empagliflozin (Jardiance, Boehringer Ingelheim) to reduce the risk of cardiovascular death in adults with type-2 diabetes (T2D) and cardiovascular disease. The decision was based on positive results from a post-marketing study required by the agency when it approved empagliflozin in 2014 as an adjunct to diet and exercise to improve glycemic control in adults with T2D.

Empagliflozin was studied in a post-marketing clinical trial involving more than 7,000 patients with T2D and cardiovascular disease. The study showed that empagliflozin reduced deaths by 32% in patients with T2D at risk of heart attack and stroke when added to standard diabetes medications. It was the first time a diabetes drug was shown to reduce the risk of cardiovascular death. Moreover, patients taking empagliflozin had a 35% lower rate of hospitalization for heart failure.

Empagliflozin can cause dehydration and hypotension; ketoacidosis, serious urinary tract infection, acute kidney injury, impairment in renal function, hypoglycemia when used with insulin or insulin secretagogues (e.g., sulfonylurea, a medication used to treat T2D by increasing the release of insulin in the pancreas), genital mycotic infections, and increased cholesterol levels.

The most common adverse effects of empagliflozin are urinary tract infections and female genital infections.

Empagliflozin is not intended for patients with type-1diabetes or for the treatment of diabetic ketoacidosis. Empagliflozin is contraindicated in patients with a history of serious hypersensitivity reactions to the drug, severe renal impairment, or end-stage renal disease, or those undergoing dialysis.

Approximately 26 million Americans have T2D, the most common form of diabetes, which is linked to obesity, according to federal data for 2014.

Sources: FDA(link is external); December 2, 2016; Reuters(link is external); December 4, 2016.