Among patients receiving recommended therapy for heart failure, those who also received empagliflozin had a lower risk of cardiovascular death or hospitalization for heart failure, according to findings from the EMPEROR-Reduced trial presented at ESC Congress 2020 and simultaneously published in the New England Journal of Medicine (NEJM). Researchers noted these findings were consistent regardless of the presence or absence of diabetes.

Researchers led by Milton Packer, MD, FACC, et al., randomly assigned 3,730 patients with chronic heart failure and an ejection fraction of 40% or less to receive empagliflozin (10 mg once daily) or placebo, in addition to recommended therapy. The patients were from 520 centers spanning 20 countries. The primary outcome was a composite of cardiovascular death or hospitalization for worsening heart failure, which occurred in 19.4% of patients assigned to the empagliflozin group, compared with 24.7% in the placebo group. Secondary outcomes included the occurrence of all adjudicated hospitalizations for heart failure, including first and re-current events, as well as the rate of the decline in the estimated glomerular filtration rate (GFR) during double-blind treatment.

"In our trial, the combined risk of cardiovascular death or hospitalization for heart failure was 25% lower among the patients who received empagliflozin than among those who received placebo, a difference that was primarily related to a 31% lower risk of hospitalization for heart failure," the researchers said. The annual rate of decline in the estimated GFR was also slower in the empagliflozin group than in the placebo group and empagliflozin-treated patients had a lower risk of serious renal outcomes. Additionally, Packer and colleagues found the benefits associated with empagliflozin "were seen in patients receiving any of the currently recommended drugs for heart failure, including sacubitril–valsartan, and were seen regardless of the presence or absence of diabetes.

"The results of EMPEROR-Reduced add more support for the role of SGLT2 inhibitors to reduce risk across a wide range of cardiovascular risk in patients with diabetes, as articulated in the recent ACC Expert Consensus Decision Pathway focused on cardiovascular risk reduction in patients with diabetes," said James Januzzi, MD, FACC, one of the study investigators and a member of the ACC's Solution Set Oversight Committee. "Cardiovascular clinicians should be thinking of SGLT2 inhibitors not only as glucose lowering drugs, but agents that substantially reduce cardiovascular risk."

In a related editorial published in NEJM, John A. Jarcho, MD, FACC, writes that the "results of the EMPEROR-Reduced trial confirm that the findings in DAPA-HF were no fluke and substantially strengthen the rationale for the use of SGLT2 inhibitors in patients with heart failure and a reduced ejection fraction." He notes that "guidelines committees will now need to contend with the evidence."

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Heart Failure and Cardiomyopathies, Prevention, Acute Heart Failure

Keywords: ESC Congress, ESC20, Dyslipidemias, Metabolic Syndrome, Primary Prevention, Heart Failure, Stroke Volume, Ventricular Dysfunction, Left, Diabetes Mellitus

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