FDA approves SGLT2i for reduction of HF hospitalization in T2DM with high CV riskNews - Oct. 22, 2019
The US Food and Drug Administration (FDA) has approved dapagliflozin for the reduction of heart failure hospitalization in T2DM patients with established CVD or multiple CV risk factors, based on the results from the DECLARE-TIMI 58 trial.
Dr. Stephen Wiviott of Brigham and Women’s Hospital and Harvard Medical School, Boston, US and a Senior Investigator with the TIMI study group and co-principal investigator of the trial, 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.”
This approval by the FDA follows the update to the marketing authorization in the EU in August 2019. The FDA has given Fast Track designation for dapagliflozin to reduce CV death or worsening of HF in HFrEF or HFpEF patients based on the DAPA-HF and DELIVER trials, and Fast Track designation to delay the progression of renal failure and reduce CV and renal death in CKD patients, based on the DAPA-CKD trial.
DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 was a phase III, randomized, double-blind, placebo-controlled, multicenter trial that examined the effect of dapagliflozin compared with placebo on CV outcomes in >17,000 T2DM patients at risk of CV events, including patients with multiple CV risk factors or established CVD and also assessed key renal secondary endpoints.