US approves Farxiga to reduce heart failure hospitalisation risk for people with type 2 diabetes

US approves Farxiga to reduce heart failure hospitalisation risk for people with type 2 diabetes


Dapagliflozin (Farxiga) has been approved in the US as a treatment to reduce the risk of hospitalisation for heart failure.

The US Food and Drug Administration (FDA) approved this specific use of the drug for people with type 2 diabetes that have either established cardiovascular disease or a number of cardiovascular risk factors.

Made by AstraZeneca, Farxiga is a sodium glucose co-transporter 2 (SGLT2) inhibitor medication. These medications help the kidneys to filter more glucose out of the blood, allowing the excess glucose to be passed out of the body via urine.

In the UK, dapagliflozin is prescribed under the slightly different name of Forxiga.

The decision to approve the drug comes nearly a year after results from the DECLARE-TIMI 58 trial, involving over 17,000 people, was published. The study showed significantly lower rates of hospitalisation for heart failure in people taking dapagliflozin compared with those taking a placebo.

Lead researcher Dr Stephen Wiviott, from Brigham and Women’s Hospital and Harvard Medical School, said: “DECLARE-TIMI 58 is a landmark trial, offering compelling evidence that dapagliflozin can reduce the risk of heart failure in patients living with type 2 diabetes with multiple risk factors for or established cardiovascular disease.

“These data could help change the way we approach diabetes management; going beyond a singular focus on glucose control to help address the risk of heart failure in a diverse population of patients.”

The results of the DECLARE-TIMI 58 trial showed that people with type 2 diabetes and at risk of atherosclerotic cardiovascular disease had a 17% lower risk of hospitalisation for heart failure than those assigned to receive placebo.

The trial showed no significant differences, between dapagliflozin and placebo, in the risks of major adverse cardiovascular events (MACE) such as heart disease, stroke from blood clots or death from cardiovascular disease.



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