Dapagliflozin Approved for Reducing Risk of Hospitalization for Heart Failure

October 21, 2019
fda logoDapagliflozin(Farxiga) has received approval from the United States Food and Drug Administration(FDA) to reduce the risk of hospitalization for heart failure in patients with type 2 diabetes.

AstraZeneca announced the approval of the drug, which has been indicated for the treatment of type 2 diabetes since 2014, was based on the results of the pivotal DECLARE-TIMI 58 trial.

“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 Stephen Wiviott, MD, of Brigham and Women’s Hospital and a lead 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.”

DECLARE-TIMI 58 was a phase 3 randomized, double-blinded, placebo-controlled, multicenter trial that evaluated the impact of dapagliflozin compared to placebo on cardiovascular outcomes in adults with diabetes at a risk of cardiovascular events. The trial included more than 17,000 patients across 33 countries.

Results of the trial indicated treatment with dapagliflozin resulted in a 17% reduction in the primary composite endpoint of hospitalization for heart failure or cardiovascular death compared to placebo(4.9% vs. 5.8%; HR 0.83 (95% CI 0.73-0.95), P=0.005). Additionally, dapagliflozin also demonstrated the ability to reduce risk of hospitalization for heart failure by 27%.

In regards to safety, a release from AstraZeneca noted the most common adverse events associated with dapagliflozin 5 mg, dapagliflozin 10 mg, and placebo respectively were female genital mycotic infections (8.4% vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and urinary tract infections (5.7% vs 4.3% vs 3.7%).

“FARXIGA is the first SGLT2 inhibitor approved in the US to reduce the risk of hospitalization for heart failure in type 2 diabetes patients with established cardiovascular disease or multiple cardiovascular risk factors,” said Ruud Dobber, executive vice president, BioPharmaceuticals Business Unit. “This is promising news for the 30 million people living with type 2 diabetes in the US, as heart failure is one of the earliest cardiovascular complications for them, before heart attack or stroke.”

In addition to the approval for reducing risk of hospitalization for heart failure, dapagliflozin recently received a Fast Track designation from the FDA for treatment of renal failure and prevent cardiovascular and renal death in patients with type 2 diabetes.
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