FDA approves new heart failure indication for SGLT-2 inhibitor
Originally approved in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes, the sodium-glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin (Jardiance) is now approved to reduce the risk of cardiovascular death and hospitalization for heart failure in adults.
The FDA has approved a new indication for empagliflozin (Jardiance) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults, the agency announced on Feb. 24.
The sodium-glucose cotransporter-2 (SGLT-2) inhibitor was originally approved by the FDA in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes. It is also approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease and to reduce the risk of death and hospitalization in patients with heart failure and low ejection fraction.
For the new indication, safety and effectiveness were evaluated as an adjunct to standard-of-care therapy in a randomized, double-blind trial comparing about 3,000 participants who received the drug (10 mg once daily) to about 3,000 who received placebo. Of those who received the drug for an average of about two years, 14% died of cardiovascular causes or were hospitalized for heart failure, compared to 17% of the participants who received placebo. This benefit was mainly attributable to fewer patients being hospitalized for heart failure.
Side effects were generally consistent with those in patients with diabetes, including urinary tract infections and female fungal infections. The drug must not be used in patients who have had a previous serious allergic reaction to it or those who are on dialysis, the FDA press release said.