New results from EMPEROR-Reduced presented at Kidney Week 2020.
New results from a recent major heart failure trial involving empagliflozin (Jardiance, Eli Lilly/Boehringer Ingelheim), the sodium glucose co-transporter 2 (SGLT2) inhibitor first developed to treat type 2 diabetes (T2D), show the drug works equally well to prevent renal decline regardless of their chronic kidney disease (CKD) status.
The first results from EMPEROR-Reduced showed that empagliflozin significantly reduces the risk of cardiovascular events and heart failure hospitalization, while slowing the decline in renal function for patients with heart failure with reduced ejection fraction (HFrEF), regardless of diabetes status. These results were presented earlier this year at the European Society of Cardiology. Findings of subanalysis presented at Kidney Week 2020, presented by the American Society of Nephrology, were also published in the journal Circulation.
This new analysis examined 3730 patients randomized to empagliflozin or placebo, of whom 1978 (53%) had chronic kidney disease (CKD). The analysis looked at (1) a composite of cardiovascular (CV) death or heart failure (HF) hospitalization and (2) total HF hospitalizations and (3) slope of estimated glomerular filtration rate (eGFR). Then, investigators measured what they defined as a sustained profound loss of kidney function, which included a decline in eGFR, chronic dialysis or transplant. The median follow-up was 16 months.
According to the abstract, results showed the following:
“On their own, heart failure and chronic kidney disease are each associated with an increased risk of hospitalizations and premature death from cardiovascular causes. The presence of one condition often accelerates the onset and progression of the other, further increasing this risk and leading to poorer prognoses,” Faiez Zannad, MD, PhD, EMPEROR Program clinical investigator and emeritus professor of Therapeutics at the University of Lorraine, France, said in a statement.
“In EMPEROR-Reduced, empagliflozin demonstrated a consistent reduction in the risk of the composite primary endpoint of cardiovascular death and heart failure hospitalizations, while slowing kidney function decline, in adults with heart failure with reduced ejection fraction, with and without chronic kidney disease. This is promising news for the growing population of adults suffering from both heart failure and chronic kidney disease.”
FDA has previously granted fast track designation for empagliflozin for the treatment of chronic kidney disease. This covers the ongoing EMPA-KIDNEY trial, which is investigating the drug’s effect on the progression of kidney disease and occurrence of cardiovascular death in adults with established CKD, with and without diabetes. Results from EMPA-KIDNEY are expected in 2022.
Zannad F, Ferreira JP, Pocock SJ, et al. Cardiac and kidney benefits of empagliflozin in heart failure across the spectrum of kidney function: insights from the EMPEROR-Reduced trial. Circulation. Published and access October 23, 2020. https://doi.org/10.1161/CIRCULATIONAHA.120.051685