Eli Lilly and Boehringer Ingelheim have reported that new exploratory sub-analysis data from the EMPEROR-Reduced Phase III trial showed Jardiance (empagliflozin) helped reduce the risk of adverse cardiovascular and kidney events in adults with heart failure with reduced ejection fraction (HFrEF).
Jardiance is used along with diet and exercise to lower blood sugar in adults and to reduce the risk of cardiovascular death in adults with type 2 diabetes.
The ‘EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure’ (EMPEROR) studies have two Phase III, randomised, double-blind trials analysing once-daily Jardiance versus placebo in heart failure patients with preserved or reduced ejection fraction, both with and without diabetes.
EMPEROR-Reduced analysed the safety and efficacy of Jardiance in 3,730 patients with HFrEF.
The trial was aimed at analysing the duration to the first event of adjudicated cardiovascular death or adjudicated hospitalisation for heart failure.
Data showed that Jardiance reduced relative risk for the composite primary endpoint of cardiovascular death or hospitalisation for heart failure by 25% and of first and recurrent hospitalisations for heart failure by 30%.
The drug also slowed down the decline in eGFR, a measure of kidney function, in heart failure patients with reduced ejection fraction with and without diabetes.
In addition, an exploratory analysis showed that Jardiance helped reduce the relative risk of a composite kidney endpoint, including end-stage kidney disease and a profound loss of kidney function, by 50%.
The safety profile of Jardiance was similar to the previously established data.
EMPEROR Program clinical investigator Faiez Zannad said: “In EMPEROR-Reduced, empagliflozin demonstrated a consistent reduction in the risk of the composite primary endpoint of cardiovascular death and heart failure hospitalisations, while slowing kidney function decline, in adults with heart failure with reduced ejection fraction, with and without chronic kidney disease.”
EMPEROR-Preserved, which is slated for completion next year, will investigate the safety and efficacy of Jardiance in patients with heart failure with preserved ejection fraction (HFpEF).
In July, Boehringer Ingelheim and Eli Lilly reported positive top-line data from the Phase III EMPEROR-Reduced trial of Jardiance in HFrEF patients with and without diabetes.