FDA Expands Drug Indication For Patients With Type 2 Diabetes and CVD
The U.S. Food and Drug Administration on Dec. 2 announced the label expansion of Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease. Based on a post-market study following its approval for glycemic control in 2014, “Jardiance was shown to reduce the risk of cardiovascular death compared to a placebo when added to standard of care therapies for diabetes and atherosclerotic cardiovascular disease.” While Jardiance may cause side effects including dehydration, hypotension, ketoacidosis and urinary tract infections when used with insulin, this new application proves a significant breakthrough for a demographic in which cardiovascular disease is the leading cause of death.
Read more on the expansion here.
Keywords: Atherosclerosis, Blood Glucose, Cause of Death, Diabetes Mellitus, Type 2, Hypotension, Insulin, United States Food and Drug Administration
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