- NEWS . 18 May 2020
FDA approves dapagliflozin for the treatment of HFrEF
Earlier this month, the US Food and Drug Administration (FDA) approved dapagliflozin for the treatment of heart failure with reduced ejection fraction (HFrEF) in adults with and without type 2 diabetes. With this approval, dapagliflozin is now the first sodium-glucose co-transporter 2 (SGLT2) inhibitor to be approved for HF management even if diabetes is not present.
HF is a frequent complication of myocardial infarction (MI). Data showed that the rate of signs and symptoms of HF after an MI is approximately 25%; importantly, its presence increases the risk of death by at least 3- to 4-fold. Hence, it could be said that the approval of dapagliflozin represents an additional treatment option that can help reduce disease burden and improve survival for patients with high-risk acute coronary syndromes.
The efficacy and safety profiles of dapagliflozin were evaluated in the phase III, double-blind, placebo-controlled Dapagliflozin And Prevention of Adverse-Outcomes in Heart Failure (DAPA-HF) trial. A total of 4,744 patients were randomized to receive either dapagliflozin (at a dose of 10 mg once daily) or placebo, in addition to the recommended therapy.
Results showed that over a median of 18.2 months, patients in the dapagliflozin group exhibited fewer cardiovascular (CV) deaths, hospitalization for heart failure, and urgent heart failure visits compared to the controls receiving placebo. Additionally, no differences were found between patients with diabetes and those without diabetes, or in the frequency of adverse events related to volume depletion, renal dysfunction and hypoglycaemia between treatment groups.
The study concluded that in addition to standard care, dapagliflozin achieved a 26% risk reduction in the composite outcome of CV death or the worsening of HF for patients with HFrEF, compared with placebo (absolute risk reduction, 5% [event rate/100 patient years: 11.6 vs 15.6, respectively]; p<0.0001).
McMurray JJV, et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med 2019;381:1995–2008.
Melillo G. FDA approves dapagliflozin to treat heart failure, breaking new ground in SGLT2 competition. Available at: https://www.ajmc.com/newsroom/fda-approves-dapagliflozin-to-treat-heart-.... Accessed 14 May 2020.
Minicucci MF, et al. Heart Failure After Myocardial Infarction: Clinical Implications and Treatment. Clin Cardiol 2011;34:410–414.