FDA Approves New Indication for Empagliflozin

The FDA has approved Jardiance (empagliflozin) for the reduction of risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease.

The decision is based on a postmarket study required by the FDA following the drug's approval in 2014 as an adjunct to diet and exercise for the improvement of glycemic control in adults with type 2 diabetes mellitus. In a study of over 7000 patients with type 2 diabetes and cardiovascular disease. Jardiance was shown to reduce the risk of cardiovascular death compared to placebo when added to standard care for diabetes and atherosclerotic cardiovascular disease.

______________________________________________________________________________________________________________________________________________________________________
RELATED CONTENT
When You Can’t Identify the Cause of a Stroke: Advanced and Specialized Tests
Study Compares NOACs for Preventing Bleeding and Stroke
______________________________________________________________________________________________________________________________________________________________________

Adverse side effects associated with Jardiance include dehydration and low blood pressure, as well as increased ketones in the blood, urinary tract infection, and impaired renal function.

The drug is not intended for use in patients with type 1 diabetes mellitus of for the treatment of diabetic ketoacidosis.

—Michael Potts

Reference:

FDA. FDA approves Jardiance to reduce cardiovascular death in adults with type 2 diabetes [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm531517.htm. December 2, 2016.