Boehringer Ingelheim and Eli Lilly and Company (Lilly) have reported positive data from the EMPEROR-Preserved Phase III trial.
The trial evaluated the safety and efficacy of Jardiance (empagliflozin) in patients with chronic heart failure with preserved ejection fraction (HFpEF).
In the trial, Jardiance demonstrated 21% reduction in risk of cardiovascular death or hospitalisation for heart failure in adults with HFpEF compared with placebo.
Additionally, the medication reduced the relative risk of first and recurrent hospitalisations for heart failure by 27%. Jardiance also decelerated the decline in kidney function.
The result was independent of ejection fraction or diabetes status.
Boehringer and Lilly have presented the results at the European Society of Cardiology (ESC) Congress 2021 and published it in The New England Journal of Medicine.
EMPEROR-Preserved principal investigator and Charité Berlin heart failure cardiologist Stefan Anker said: “For people with heart failure with preserved ejection fraction, the reality is that so far there are no clinically proven treatments we can offer that would make a significant impact on their condition.
“This data brings hope for millions of patients suffering from heart failure with a preserved ejection fraction. The primary endpoint was similarly improved in all subgroups of patients, in men and women, with and without diabetes, and regardless of their ejection fraction and kidney function level.”
Overall, the trial included 5,988 people with heart failure including 4,005 with a left ventricular ejection fraction (LVEF) of 50% or above.
The results were consistent with those of the EMPEROR-Reduced trial that assessed the efficacy of Jardiance in patients with chronic heart failure with reduced ejection fraction (HFrEF).
Recently, the US Food and Drug Administration (FDA) approved Jardiance for reduction of risk of cardiovascular death plus hospitalisation for heart failure in adults with HFrEF.
Currently, the medicine is also being tested for chronic kidney disease.