Boehringer Ingelheim and Eli Lilly and Co. (LLY) announced Tuesday that the EMPEROR-Preserved phase III trial met its primary endpoint, establishing Jardiance (empagliflozin) as the first and only therapy to significantly reduce the risk of the composite of cardiovascular death or hospitalization for heart failure in adults, with or without diabetes, who live with heart failure with preserved ejection fraction (HFpEF).
Heart failure with preserved ejection fraction has been classified as “the single largest unmet need in cardiovascular medicine”¹ based on prevalence, poor outcomes and absence of clinically proven therapies to date.
With approval, Jardiance would become the first and only clinically proven therapy to improve outcomes for the full spectrum of heart failure patients regardless of ejection fraction.
Jardiance was also the first SGLT2 inhibitor to reduce cardiovascular death for people with type 2 diabetes and cardiovascular disease
The EMPEROR heart failure studies are part of our EMPOWER clinical trial program exploring the effect of Jardiance across a spectrum of cardio-renal-metabolic diseases, aiming to significantly improve outcomes in these highly prevalent conditions that impact many people’s lives.
The EMPEROR-Preserved trial investigated Jardiance 10 mg compared with placebo. Boehringer Ingelheim and Lilly plan for regulatory submissions in 2021.
These results add to previous findings from the EMPEROR-Reduced phase III trial, which showed that Jardiance significantly reduced the combined relative risk of cardiovascular death or hospitalization for heart failure by 25% compared to placebo in adults with heart failure with reduced ejection fraction (HFrEF).
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