Jardiance Approved to Reduce Cardiovascular Deaths in Adults With Type 2 Diabetes

On December 2, the U.S. Food and Drug Administration (FDA) expanded the approved use of the oral diabetes medication Jardiance (generic name empagliflozin) to include reducing the risk of cardiovascular death in adults with Type 2 diabetes and cardiovascular disease. Cardiovascular disease is the leading cause of death in people with diabetes, who are at least twice as likely as those without diabetes to have heart disease or a stroke.

Jardiance, marketed by Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company, is from a class of diabetes drugs known as SGLT2 inhibitors. In the process of filtering the blood, the kidneys typically reabsorb all the filtered glucose and return it to the bloodstream. One of the main proteins responsible for this reabsorption is SGLT2. By inhibiting the action of SGLT2, Jardiance blocks the reabsorption of glucose by the kidneys, promoting a loss of glucose in the urine and lowering blood glucose levels.

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Jardiance is the first Type 2 diabetes medicine to be approved to reduce the risk of cardiovascular death. The new use was approved based on results from a postmarketing clinical trial of more than 7,000 people with Type 2 diabetes and cardiovascular disease, which showed that Jardiance reduced the risk of cardiovascular death compared to a placebo (inactive treatment) when added to standard therapies for diabetes and cardiovascular disease.

This medicine should not be used in people with Type 1 diabetes, diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body), or severe kidney problems.

The most commonly reported side effects of Jardiance include urinary tract infections and female genital infections.

For more information about Jardiance’s new indication, see the press releases on the FDA or Eli Lilly websites.

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