FDA approves SGLT2 inhibitor to reduce CV mortality in high-risk adults with type 2 diabetesNews - Dec. 2, 2016
The U.S. Food and Drug Administration (FDA) today approved a new indication for empagliflozin to reduce the risk of cardiovascular (CV) death in adult patients with type 2 diabetes mellitus and established CV disease.
According to the Centers for Disease Control and Prevention, death from CV disease is 70 percent higher in adults with diabetes compared to those without diabetes, and patients with diabetes have a decreased life expectancy driven in large part by premature CV death.
The FDA’s decision is based on the postmarketing study required by the agency when it approved empagliflozin in 2014 as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. Empagliflozin was studied in the EMPA-REG OUTCOME trial of more than 7,000 patients with type 2 diabetes and cardiovascular disease. In the trial, empagliflozin was shown to reduce the risk of CV death compared to a placebo when added to standard of care therapies for diabetes and atherosclerotic cardiovascular disease.
Empagliflozin can cause dehydration and hypotension. Empagliflozin can also cause ketoacidosis, serious urinary tract infection, acute kidney injury and impairment in renal function, hypoglycaemia when used with insulin or insulin secretagogues (e.g. sulfonylurea, a medication used to T2DM by increasing the release of insulin in the pancreas), vaginal yeast infections and yeast infections of the penis (genital mycotic infections), and increased cholesterol. The most common side effects of empagliflozin are urinary tract infections and female genital infections.
Empagliflozin is not intended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Empagliflozin is contraindicated in patients with a history of serious hypersensitivity reactions to empagliflozin, severe renal impairment, end-stage renal disease, or dialysis.