Empagliflozin meets primary endpoint in Phase III heart failure trial

Positive top-line results from the EMPEROR-Reduced Phase III trial in adults with heart failure with reduced ejection fraction, with and without diabetes, were today announced by Boehringer Ingelheim. EMPEROR-Reduced met its primary endpoint, demonstrating superiority with empagliflozin (10 mg) compared to placebo in reducing the risk for the composite of cardiovascular death or hospitalisation due to heart failure when added to standard of care. The safety profile in all participants independent of type 2 diabetes was similar to the known safety profile of empagliflozin.

“The results of the EMPEROR-Reduced trial indicate that SGLT2 inhibitors have the potential to become the new standard of care for this disease, which will be a meaningful addition to the currently established treatments,” said Milton Packer, Chair of the Executive Committee for the EMPEROR Program and Distinguished Scholar in Cardiovascular Science at Baylor University Medical Center in Dallas, Texas, US. “

Heart failure is the leading cause of hospitalisation in the US and Europe, and the number of patients across Asia is also increasing. Heart-failure related mortality is particularly high in Indian patients, as observed in INTER-CHF study.

“One in five people can expect to develop heart failure in their lifetime, so it is very encouraging to see these positive results from the EMPEROR-Reduced trial demonstrating that empagliflozin improves heart failure outcomes,” said Waheed Jamal, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim.

Dr Shraddha Bhure, Medical Director of Boehringer Ingelheim India said, “India bears a huge burden of heart failure, not only due to the size of our population but also the increased risk conferred by several predisposing factors. Moreover, Indian patients with heart-failure also carry a much higher risk of dying, as compared to global patient-population.”

She added, “The results of EMPEROR-Reduced study bring new hope in this regard, in showing promising outcomes with the use of empagliflozin, in patients with chronic heart failure and reduced ejection fraction. Empagliflozin is already indicated for the reduction of risk of cardiovascular death, in patients with type-2 diabetes and established cardiovascular disease. This global multi-centric study, which also included a fair patient-representation from India, opens up a new avenue to address the apparent problem of heart failure in our setting.”

Full results from the EMPEROR-Reduced trial will be presented in a hotline session at the European Society of Cardiology (ESC) Congress 2020. A second trial, EMPEROR-Preserved, will explore the effect of empagliflozin on cardiovascular death and hospitalisation for heart failure in adults with heart failure with preserved ejection fraction. EMPEROR-Preserved results are expected in 2021.