Breakthrough EMPEROR-Preserved phase 3 trial for empagliflozin (Jardiance®) meets primary end point and demonstrates benefit in patients with heart failure with preserved ejection fraction (HFpEF)

Breakthrough EMPEROR-Preserved phase 3 trial for empagliflozin (Jardiance^®) meets primary end point and demonstrates benefit in patients with heart failure with preserved ejection fraction (HFpEF)

·         Heart failure with preserved ejection fraction (HFpEF) has been classified as “the single largest unmet need in cardiovascular medicine” based on prevalence and poor outcomes for patients[i]

·         Topline Phase III trial results demonstrate significant risk reduction with empagliflozin for cardiovascular death or hospitalization for heart failure in adult patients with HFpEF[ii]

·         The study included patients with and without type 2 diabetes

Bracknell, UK, 6 July 2021 – The EMPEROR-Preserved Phase 3 trial has met its primary endpoint, establishing empagliflozin (Jardiance^®) as the first SGLT2 inhibitor treatment to significantly reduce the risk of cardiovascular death or hospitalization for heart failure in adults living with HFpEF, with or without diabetes. Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced the topline results today. The safety profile was generally similar to the known safety profile of empagliflozin. [^ii]

“The EMPEROR-Preserved topline results represent a significant breakthrough in cardiovascular medicine and for people with heart failure, which is an increasingly prevalent public health issue affecting millions of people worldwide,” said Iain Squire, Professor of Cardiovascular Medicine at the University of Leicester, and Lead Investigator for EMPEROR-Preserved in the UK.  “HFpEF has been the most challenging form of heart failure to treat, given the lack of evidence-based treatments up until now. The findings from EMPEROR-Preserved demonstrate the potential of empagliflozin to reduce cardiovascular death or hospitalization for heart failure with preserved ejection fraction. This really is a landmark finding in the treatment of heart failure and opens up the possibility of improving prognosis for patients with HFpEF.”

In the UK and Ireland, heart failure is the most common cause of hospital admission in people aged over 65. [^XVIII], [^XIX] Heart failure is a leading cause of hospitalization and is becoming increasingly prevalent in developing countries due to aging populations.[iii]^,[iv] The risk of death in people with heart failure rises with each hospital admission.[v] Heart failure with left ventricular preserved ejection fraction occurs when the left ventricle of the heart is unable to fill properly, resulting in less blood being pumped to the body.

“These highly anticipated results demonstrate the potential of empagliflozin in heart failure with preserved ejection fraction which can be devastating to those affected, impacting their daily activities while posing a greater risk of other vascular complications,” said Dr Douglas Clark, Head of Medical Affairs for UK and Ireland at Boehringer Ingelheim. “The BI/Lilly Alliance is committed to exploring how we can help to support these patients and developing new treatment options for their healthcare professionals.”

The EMPEROR-Preserved trial investigated empagliflozin 10 mg on top of standard of care compared with placebo.[^Vii] Full results from the EMPEROR-Preserved trial are scheduled for presentation at the European Society of Cardiology (ESC) Congress 2021 on 27 August.