FDA approves drug that reduces risk of cardiovascular death in diabetics
Posted: 12 December 2016 | | No comments yet
It significantly reduced the risk of (the combined primary endpoint) cardiovascular death, non-fatal heart attack or non-fatal stroke by 14% versus placebo…
The US Food and Drug Administration (FDA) approved a new indication for Jardiance (empagliflozin) tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.
Jardiance is the first type 2 diabetes treatment approved with this additional indication and the only oral type 2 diabetes medicine shown in a clinical trial to provide a life-saving cardiovascular benefit. It is marketed by Boehringer Ingelheim and Eli Lilly.
It is not for people with type 1 diabetes or people with diabetic ketoacidosis (increased ketones in the blood or urine).
“People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes. The new indication for empagliflozin enables physicians for the first time to provide adults with type 2 diabetes with a diabetes medication that can reduce their risk of dying from cardiovascular disease,” said Christopher Cannon, MD, Harvard Medical School.
The approval is based on breakthrough evidence from a clinical trial, which investigated the effects of Jardiance, compared with placebo, when added to standard of care type 2 diabetes and cardiovascular medicines.
Primary endpoint specifics
It significantly reduced the risk of (the combined primary endpoint) cardiovascular death, non-fatal heart attack or non-fatal stroke by 14% versus placebo. This primary finding was driven by a significant 38% reduction in the risk of cardiovascular death. There was no change in the risk of non-fatal heart attack or non-fatal stroke. The cardiovascular benefits were consistent among patient subgroups.
“Despite significant medical advances, approximately two out of three people with type 2 diabetes still die from cardiovascular disease. The Boehringer Ingelheim and Lilly diabetes alliance is proud to bring a ground breaking innovation to millions of adults with type 2 diabetes and established cardiovascular disease,” said Enrique Conterno, Lilly Diabetes.
In 2014, Jardiance was approved by the FDA as an adjunct to diet and exercise to improve glycaemic control, or blood glucose levels, in adults with type 2 diabetes.
