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FDA has approved Jardiance to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease


The FDA ( Food and Drug Administration ) has 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.

The approval is based on breakthrough evidence from the landmark EMPA-REG OUTCOME trial, which investigated the effects of Empagliflozin compared with placebo when added to standard of care type 2 diabetes and cardiovascular medicines in adults with type 2 diabetes and established cardiovascular disease.
In the trial, Empagliflozin significantly reduced the risk of the combined primary endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke by 14% versus placebo ( hazard ratio, HR=0.86, 95% CI: 0.74-0.99 ); absolute risk reduction was 1.6% for Empagliflozin versus placebo.
This primary finding was driven by a significant 38% reduction in the risk of cardiovascular death ( HR=0.62, 95% CI: 0.49-0.77 ); absolute risk reduction was 2.2% for patients taking Empagliflozin versus placebo.
There was no change in the risk of non-fatal myocardial infarction ( HR=0.87, 95% CI: 0.70-1.09 ) or non-fatal stroke ( HR=1.24, 95% CI: 0.92-1.67 ).
The cardiovascular benefits of Empagliflozin were consistent among patient subgroups.

Adults with type 2 diabetes should not take Jardiance if they have severe kidney problems or are on dialysis, or if they are allergic to Empagliflozin or any ingredient in Jardiance.
Jardiance can cause dehydration and low blood pressure.
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 when used with insulin or insulin secretagogues ( e.g., sulfonylurea, a medication used to treat type 2 diabetes ), vaginal yeast infections and yeast infections of the penis, and increased cholesterol.

People with diabetes mellitus are two to four times more likely to develop cardiovascular disease than people without diabetes. The new indication for Jardiance 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.

In 2014, Jardiance was approved by the FDA as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes mellitus.

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 mellitus 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.

Empagliflozin is an oral, once daily, highly selective sodium glucose co-transporter 2 ( SGLT2 ) inhibitor approved for the treatment of adults with type 2 diabetes mellitus.
Empagliflozin works by blocking the reabsorption of glucose by the kidney, leading to urinary glucose excretion, and lowering blood glucose levels in people with type 2 diabetes.
SGLT2 inhibition targets glucose directly and works independently of beta-cell function and the insulin pathway. ( Xagena )

Source: Boehringer Ingelheim, 2016

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