The full results from the Emperor-Preserved trial show Jardiance reduces the risk of hospital and death from heart failure.
Full results from the EMPEROR-Preserved phase 3 trial demonstrated that Jardiance (empagliflozin) showed a 21% relative risk reduction for the composite primary end point of cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction compared with placebo. These results were presented at the European Society of Cardiology Congress 2021 and published in The New England Journal of Medicine.
The benefit was independent of ejection fraction or diabetes status, according to a press release from Boehringer Ingelheim and Eli Lilly. Jardiance also reduced the relative risk of first and recurrent hospitalizations for heart failure by 27% and slowed kidney function decline.
“This data brings hope for millions of patients suffering from heart failure with a preserved ejection fraction. The primary end point 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. This underlines the breadth of empagliflozin's efficacy and its potential overall impact,” Professor Stefan Anker, EMPEROR-Preserved principal investigator and heart failure cardiologist at Charité Berlin, Germany, said in a statement.
EMPEROR-Preserved included 5,988 people with heart failure. Of these, 4,005 had a left ventricular ejection fraction of 50% or above and 1,983 had a LVEF below 50%.
The companies had released initial data from this study in July. Read more here.
The results seen in this trial were similar to those in EMPEROR-Reduced trial, which was the basis for FDA approval of Jardiance for the treatment of chronic heart failure with reduced ejection fraction. In this study, investigators evaluated adding Jardiance 10 mg to standard of care in a broad range of 3,730 adults with and without type 2 diabetes who had heart failure and a left ventricular ejection fraction of 40% or less. In the trial, Jardiance reduced the relative risk of the primary composite endpoint of time to cardiovascular death or hospitalization for heart failure by 25%.
Research is ongoing regarding the effects of Jardiance on hospitalization for heart failure and mortality in post-myocardial infarction patients with high risk of heart failure. Jardiance is also currently being investigated in chronic kidney disease.
In July, the companies released data from the real-world EMPRISE trial. Read more here.
More than 6 million people in the United States have heart failure, and about half of them have heart failure with preserved ejection fraction. This is an area of unmet need based on prevalence, poor outcomes and the absence of clinically proven therapies to date.
Jardiance is also approved to lower blood sugar in adults with type 2 diabetes, to reduce the risk of cardiovascular death in adults with type 2 diabetes. It is not for people with type 1 diabetes; it may increase their risk of diabetic ketoacidosis