FDA approves SGLT2i for treatment of HFrEF patients
The SGLT2 inhibitor dapagliflozin has been approved in the US to reduce CV death and hospitalization for HF in HFrEF patients with and without T2DM. This decision by the FDA was based on the positive results from the DAPA-HF trial. The DAPA-HF trial showed that dapagliflozin reduced CV death and hospitalization for HF compared to placebo.
John McMurray, MD, University of Glasgow, UK, said: “The ground-breaking results of the DAPA-HF trial have transformed heart failure therapeutics. Today’s approval provides physicians with a completely novel pharmacological approach that greatly improves outcomes for patients with heart failure with reduced ejection fraction.”
The DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure) trial is an international, multi-center, parallel-group, randomized, double-blinded trial in 4744 HFrEF patients with and without T2DM. showed that dapagliflozin, in addition to standard of care, reduced risk of the composite outcome of CV death or worsening of HF by 26% compared to placebo in patients with HFrEF (absolute risk reduction was 5%, event rate/100 PY: 11.6 vs. 15.6, respectively, P<0.0001, NNT was 21). Safety profile of dapagliflozin in the DAPA-HF trial was consistent with that observed in previous trials.
In October 2019, the FDA approved dapagliflozin to reduce risk of hospitalization for HF in T2DM patients with established CVD or multiple CV risk factor. This approval was based on the DECLARE-TIMI 58 trial. It is also indicated as an adjunct to diet and exercise to improve glycemic control in T2DM patients.