Dapagliflozin Gets Expanded Indication for Prevention of HF Hospitalization in Type 2 Diabetes
The additional approval is based on the results of the DECLARE-TIMI 58 trial.
The US Food and Drug Administration has granted an expanded indication to dapagliflozin (Farxiga; AstraZeneca) to decrease risk of heart failure hospitalization in patients with type 2 diabetes and established CVD or multiple risk factors for CVD, the drug’s manufacturer announced today. Dapagliflozin is the first sodium-glucose cotransporter 2 (SGLT2) inhibitor approved in the US for this indication.
The additional indication is based on results of the DECLARE-TIMI 58 trial, which found that 10 mg per day of dapagliflozin resulted in a significant reduction in the composite of CV death or hospitalization for heart failure compared with placebo (4.9% vs 5.8%; HR 0.83; 95% CI 0.73-0.95), one of two primary endpoints in this study. This benefit was driven entirely by a relative 27% reduction in the risk of heart failure hospitalization (HR 0.73; 95% CI 0.61-0.88).
In a press release, Stephen Wiviott, MD (Brigham and Women’s Hospital, Boston, MA), principal investigator of DECLARE-TIMI 58, said the 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.”
Separately, another dapagliflozin indication is under “fast track” review with the FDA, this one addressing its use in the reduction of CV death or the worsening of heart failure in patients with reduced ejection fraction (HFrEF) or preserved ejection fracture (HFpEF), with or without diabetes, based on the DAPA-HF and DELIVER trials.
AstraZeneca. Farxiga approved in the US to reduce the risk of hospitalization for heart failure in patients with type 2 diabetes. Published on: October 21, 2019. Accessed on: October 21, 2019.