FDA approves Jardiance for adults with type 2 diabetes

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Clinical trials have concluded for the use of Jardiance (empagliflozin) for the use in reducing the risk of cardiovascular death in type 2 diabetic adults. Jardiance is traditionally a diabetes medication which works by helping the kidneys get rid of glucose from your bloodstream. Jardiance is distributed by Boehringer Ingelheim Pharmaceutical, Inc., based in Ridgefield Connecticut.

The FDA’s press release early in December announced that placebo controlled clinical trials indicated that the inhibitor of sodium-glucose cotransporters type 2 is effective for use in patients with type 2 diabetes mellitus and known cardiovascular disease. Jardiance was studied in a post market trial of more than 7000 patients with type 2 diabetes and cardiovascular disease.

According to the Center for Disease Control and Prevention (CDC), death from cardiovascular disease is 70 percent higher in adults with diabetes compared to those without diabetes. Diabetes itself is characterized by a decreased life expectancy as a result of premature death, with one of the main cause being cardiovascular related complications. Jean-Marc Guettier, M.D., C.M., director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and research was quoted as saying “Availability of antidiabetes therapies that can help people live longer by reducing the risk of cardiovascular death is an important advance for adults with type 2 diabetes.”

The most common side effects of Jardiance are urinary tract infections and female genital infections. Other side effects for Jardiance are listed as possibly causing dehydration and low blood pressure (hypotension). Jardiance can also cause increased ketones in the blood (ketoacidosis), serious urinary tract infection, acute kidney injury and impairment in renal function, low blood glucose (hypoglycemia) when used with insulin or insulin secretagogues, vaginal yeast infections and yeast infections of the penis (genital mycotic infections), and increased cholesterol.

Jardiance is not intended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Jardiance is contraindicated in patients with a history of serious hypersensitivity reaction to Jardiance, sever renal impairment, end-stage renal disease or dialysis.

Sources:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm531517.htm

https://www.ncbi.nlm.nih.gov/pubmed/26738271

http://www.medscape.com/viewarticle/873511

https://www.drugs.com/jardiance.html