Drugs Xagena
The FDA ( Food and Drug Administration ) Advisory Committee has voted 12-11 that substantial evidence exists to establish that Jardiance ( Empagliflozin ) reduces cardiovascular death in adults with type 2 diabetes ( T2D ) and established cardiovascular disease.
Empagliflozin is the only oral T2D medicine shown in a clinical trial to reduce the risk of cardiovascular death.
The recommendation was made by the Endocrinologic and Metabolic Drugs Advisory Committee based on data from the landmark EMPA-REG OUTCOME trial, which found that Empagliflozin significantly reduced the risk of the combined endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14% when added to standard of care in adults with type 2 diabetes and established cardiovascular disease.
The primary finding was driven by a 38% reduction in cardiovascular death, with no significant difference in the risk of non-fatal heart attack or non-fatal stroke.
The overall safety profile of Empagliflozin was consistent with that of previous trials.
EMPA-REG OUTCOME was a long-term, multicenter, randomized, double-blind, placebo-controlled trial of more than 7,000 patients, from 42 countries, with type 2 diabetes and established cardiovascular disease.
The study assessed the effect of Empagliflozin ( 10 mg or 25 mg once daily ) added to standard of care compared with placebo added to standard of care. Standard of care was comprised of glucose-lowering agents and cardiovascular drugs ( including for blood pressure and cholesterol ).
The primary endpoint was defined as time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.
Due to the complications associated with diabetes, such as high blood glucose, high blood pressure and obesity, cardiovascular disease is a major complication and the leading cause of death associated with diabetes.
People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes. ( Xagena )
Source: Boehringer Ingelheim, 2016
XagenaMedicine_2016
