Empagliflozin FDA Approved for Prevention of Cardiovascular Death

Topic: Cardiometabolic Health/CVD Prevention date: 12/02/2016 Featured Expert: N/A

Empagliflozin becomes the first diabetes therapy to win FDA approval for the prevention of cardiovascular death.


In an unprecedented move, the US FDA approved the SGLT-2 inhibitor empagliflozin for the prevention of cardiovascular death in patients with type 2 diabetes and coexisting cardiovascular disease (CVD).

Empagliflozin was first approved in 2014 for the treatment of type 2 diabetes and later demonstrated cardiovascular risk reduction in the EMPA-REG trial. Specifically, treatment with empagliflozin significantly reduced the risk of myocardial infarction, stroke, and CV death, as well as death from any cause and hospitalization for heart failure, in more than 7000 adults with type 2 diabetes at high CV risk.

The FDA released a statement with the approval indicating the “availability of anti-diabetes therapies that can help people live longer by reducing the risk of cardiovascular death is an important advance for adults with type 2 diabetes.”

References:

Jardiance wins CV prevention indication.

Zinman B, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373:2117-2128.

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