The Food and Drug Administration (FDA) has approved Farxiga (dapagliflozin; AstraZeneca) to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. 

The approval was based on data from the DECLARE-TIMI 58 study which evaluated the effect of Farxiga (n=8582) vs placebo (n=8578) on cardiovascular outcomes when added to current background therapy; all patients in the study had type 2 diabetes and either established CVD or 2 or more additional CV risk factors (≥55 years old in men or ≥60 years old in women and 1 or more of dyslipidemia, hypertension, or current tobacco use). 

Results showed that treatment with Farxiga was superior to placebo in reducing the incidence of the primary composite end point of hospitalization for heart failure or CV death (hazard ratio [HR] 0.83 [95% CI: 0.73, 0.95; P =.005]). The treatment effect was due to a significant reduction in the risk of hospitalization for heart failure in patients treated with Farxiga (HR 0.73; [95% CI: 0.61, 0.88]).

“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,” said Dr Stephen Wiviott of Brigham and Women’s Hospital and Harvard Medical School, Boston, and a Senior Investigator with the TIMI study group and co-principal investigator of the trial. “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.”

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Farxiga, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, is already approved for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

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