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Breakthrough heart failure drug meets primary endpoint

pharmafile | July 7, 2021 | News story | Research and Development  

The Phase III trial for empagliflozin, a treatment for patients with heart failure with preserved ejection fraction, has met its primary endpoint.

This makes empagliflozin the first SGLT2 inhibitor treatment to significantly reduce the risk of cardiovascular death or hospitalisation for heart failure in adults living with HFpEF, with or without diabetes.

Heart failure with HFpEF has been established as the single largest unmet need in cardiovascular medicine due to its prevalence and poor outcomes for patients.

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Iain Squire, Professor of Cardiovascular Medicine at the University of Leicester, and Lead Investigator for the trial in the UK, said: “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.

“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 hospitalisation 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.”

Dr Douglas Clark, Head of Medical Affairs for UK and Ireland at Boehringer Ingelheim, said: “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.

“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.”

In the UK and Ireland, heart failure is the most common cause of hospital admission in people aged over 65 and the risk of death in people with heart failure rises with each hospital admission.

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.

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