Results of the DAPA-HF trial demonstrate the efficacy and safety of dapagliflozin in patients with heart failure.
When added to standard therapy, dapagliflozin (Farxiga, AstraZeneca) reduced the risk of mortality and heart failure (HF) events, improved symptoms in patients with heart failure, and reduced ejection fraction (HFrEF), both with and without type 2 diabetes, according to late-breaking clinical results presented at the American Heart Association 2019 Scientific Sessions.1
The findings, which were published in Circulation, are from the phase 3 Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial.2
Because the benefits of sodium-glucose cotransporter 2 (SGLT2) inhibitors may be glucose-independent, the study aimed to test whether they could be used to treat patients without type 2 diabetes as well, according to the authors.1
In the study, the SGLT2 inhibitor dapagliflozin was evaluated in patients with HFrEF, with and without type 2 diabetes. Patients received either dapagliflozin 10 mg or placebo, given once daily in addition to standard of care therapy, for the prevention of CV death or reduction of HF events.2
The study included 4744 adult patients with symptomatic HFrEF, which had been present for at least 2 months, on standard of care treatment, with elevated NT-proBNP levels and eGFR ≥30mL/min/1.73 m2 at enrollment.2
Overall, the composite outcome of heart failure hospitalization, urgent heart failure visit, or death from cardiovascular causes was improved, with an absolute risk reduction of 5% over 18 months, according to the results. All components were improved, including all-cause death, quality of life, and renal function, and the findings were independent of the patient’s HbA1c level.1
Although adverse events and study drug discontinuation increased with age, neither was significantly more common with dapagliflozin in any age group, according to the study.2
Discussant Larry A. Allen, MD, MHS, from University of Colorado School of Medicine, Colorado Program for Patient Centered Decisions, noted that the improved outcomes were meaningful and essentially independent of HbA1c.3 In patients with HFrEF, SGLT2 inhibitors may be considered irrespective of type 2 diabetes, he concluded.