Empagliflozin (Jardiance®) meets primary endpoint in Phase III heart failure trial with and without diabetes

• Empagliflozin (10 mg) (Jardiance^®)^1,2 significantly reduced the risk of cardiovascular death or hospitalisation for heart failure versus placebo on top of guideline-directed medical therapy in adults with heart failure with reduced ejection fraction, meeting the EMPEROR-Reduced trial primary endpoint
• The study included patients with and without type 2 diabetes
• Survival of heart failure in the UK still lags behind other serious conditions like cancer and has only shown modest improvement in recent years³
• There remains an unmet need in the treatment of heart failure with over half of those diagnosed in the UK dying within five years⁴
• The true burden of heart failure in Ireland is still not fully understood and the recorded number of deaths attributed to heart failure may be underestimated⁵

Bracknell and Basingstoke, UK – Positive top-line results from the EMPEROR-Reduced Phase III trial in adults with heart failure with reduced ejection fraction (HFrEF), with and without type 2 diabetes, were announced today by Boehringer Ingelheim and Eli Lilly and Company. EMPEROR-Reduced met its primary endpoint, demonstrating superiority with empagliflozin (10mg)^1,2 compared to placebo in reducing the risk for the composite of cardiovascular death or hospitalisation due to heart failure, when added on top of guideline-directed medical therapy. Overall, the safety profile was similar to the known safety profile of empagliflozin.

“Heart failure is a common, but very serious chronic cardiovascular disorder, and it causes substantial disability while threatening the lives of millions of people worldwide,” said Milton Packer, M.D., Chair of the Executive Committee for the EMPEROR Program and Distinguished Scholar in Cardiovascular Science at Baylor University Medical Center in Dallas, Texas, US. “The results of the EMPEROR-Reduced trial indicate that SGLT2 inhibitors have the potential to become new standard of care for this disease, which will be a meaningful addition to the currently established treatments.”

In the UK and Ireland, heart failure is the most common cause of hospital admission in people aged over 65.^6,7 It is also the leading cause of hospitalisation in the US and Europe.⁸ The risk of death in people with heart failure rises with each hospital admission.⁹ Heart failure with reduced ejection fraction occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared to a normally functioning heart.¹⁰ Symptoms associated with heart failure, such as breathlessness and fatigue, can impact quality of life.¹¹

“With over one million people living with heart failure today in the UK and Ireland, and around 200,000 new cases diagnosed each year in the UK alone, it is becoming increasingly important that new treatment options are explored,” said Professor Iain Squire, Department of Cardiovascular Sciences, University of Leicester British Heart Foundation Cardiovascular Research Centre and NIHR Leicester Biomedical Research Centre. “In spite of significant advances in treatment in the past 25 years, the prognosis for patients with heart failure remains poor, with risk of premature death and hospital admission.”

“Heart failure can be devastating to those who are affected, impacting on daily activities and leaving people at a greater risk of other vascular complications,” said Dr Juliet Roberts, Medical Director, 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.”

Full results from the EMPEROR-Reduced trial will be presented at the European Society of Cardiology (ESC) congress 2020, on 29 August 2020.

The EMPEROR trials are part of the EMPOWER clinical programme, one of the broadest and most comprehensive of any SGLT2 inhibitor, exploring the impact of empagliflozin on the lives of people across the spectrum of cardio-renal-metabolic conditions.¹²