Boehringer Ingelheim and Eli Lilly have reported that their oral drug empagliflozin met the primary goal in Phase III EMPEROR-Preserved trial in adults with heart failure with preserved ejection fraction (HFpEF).
Sold as Jardiance, empagliflozin is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor administered once daily.
It is the first type 2 diabetes drug to include data on cardiovascular death risk reduction in its label in various countries, Boehringer noted.
The EMPEROR-Preserved trial analysed the safety and efficacy of 10mg empagliflozin against placebo in 5,988 chronic HFpEF patients with or without diabetes.
Time to first adjudicated cardiovascular death or adjudicated hospitalisation for heart failure event was the trial’s primary goal.
Top-line data from the trial demonstrate empagliflozin as the first drug to substantially lower the risk of the composite of cardiovascular death or hospitalisation for heart failure in adult HFpEF patients.
Furthermore, empagliflozin’s safety in the trial was in line with the already established profile.
The latest data add to earlier findings from the Phase III EMPEROR-Reduced trial.
In the EMPEROR-Reduced trial, empagliflozin mitigated the collective relative risk of cardiovascular death or hospitalisation for heart failure by 25% versus placebo in adults with heart failure with reduced ejection fraction (HFrEF).
Boehringer noted that these trials show the efficacy of the drug for people with all types of heart failure irrespective of ejection fraction.
Boehringer and Lilly intend to seek regulatory approval for empagliflozin in HFpEF indication this year.
Boehringer Ingelheim corporate vice-president and CardioMetabolic Medicine head Waheed Jamal said: “The totality of evidence from the trial points to the potential of empagliflozin to redefine treatment of heart failure with preserved ejection fraction, which affects approximately 30 million people worldwide.
“Until now, there have been no clinical studies demonstrating reduced risk of heart failure hospitalisations or cardiovascular mortality for all adults with this prevalent and life-limiting condition.”
Based on data from the EMPEROR-Reduced trial, the European Commission approved the use of Jardiance for the treatment of HFrEF in adults.