Jardiance Approved to Reduce Cardiovascular Death in Adults Who Have Type 2 Diabetes
Study links the drug to better survival in patients who have type 2 diabetes and cardiovascular disease
The U.S. Food and Drug Administration (FDA) has approved a new use for Jardiance to lessen the risk of cardiovascular death for adult patients who have type 2 diabetes as well as cardiovascular disease.
"Cardiovascular disease is a leading cause of death in adults with type 2 diabetes mellitus," said 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. "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 Centers for Disease Control and Prevention says that the death rate from cardiovascular disease is 70 percent higher in adults who have diabetes when compared to those who do not have diabetes, and diabetic patients have a decreased life expectancy caused largely by premature cardiovascular death.
The FDA made its decision based on a postmarketing study it required upon approving Jardiance in 2014 as an adjunct to diet and exercise for improving glycemic control in adults who have type 2 diabetes. The drug was studied in a postmarket clinical trial including more than 7,000 patients who have both type 2 diabetes and cardiovascular disease. In this trial, it was shown to lessen the risk of cardiovascular death in comparison with a placebo upon being added to standard of care therapies for diabetes and atherosclerotic cardiovascular disease.
Jardiance can result in dehydration and low blood pressure, and it can also cause increased ketones in the blood, serious urinary tract infection, acute kidney injury and renal function impairment, low blood glucose when used in conjunction with insulin or insulin secretagogues, vaginal yeast infections and yeast infections of the penis, and higher cholesterol.
The most common side effects of the drug include urinary tract infections and female genital infections. It is not meant for patients who have type 1 diabetes or for treating diabetic ketoacidosis. Finally, it is contraindicated in those patients who have a history of serious hypersensitivity reactions to the drug, severe renal impairment, end-stage renal disease, or dialysis.