Boehringer Ingelheim has said that its EMPEROR-Reduced phase II trial in adults with heart failure with reduced ejection fraction, with and without diabetes met its primary endpoint, demonstrating superiority with empagliflozin (10mg) compared to placebo. It reduced the risk for the composite of cardiovascular death or hospitalization 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.
“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. 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,” said Dr Milton Packer, chair of the executive committee for the EMPEROR Programme and Distinguished Scholar in Cardiovascular Science at Baylor University Medical Center, Dallas, Texas.
Heart failure is the leading cause of hospitalization 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. The risk of death in people with heart failure rises with each hospital admission.
“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 Dr Waheed Jamal, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim.
. “We are excited to share the full results and are working tirelessly to explore how empagliflozin can improve the lives of people living with heart failure,” he added.
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. For instance, hypertension, diabetes, ischaemic heart disease, and/or kidney disease are widely prevalent in our adult population. Not only do these risk-factors affect our Indian adults at relatively younger ages, but these also remain inadequately controlled. This myriad of cardio-renal-metabolic risks naturally lead to an increased predisposition for heart-failure, in our population,” said Dr. Shraddha Bhure, medical director , Boehringer Ingelheim India.
Full results from the EMPEROR-Reduced trial will be presented in a hot line session at the European Society of Cardiology (ESC) congress 2020, 29 August. A second trial, EMPEROR-Preserved, will explore the effect of empagliflozin on cardiovascular death and hospitalization for heart failure in adults with heart failure with preserved ejection fraction. This is an area of high unmet need as there are currently no treatment options available for people with heart failure with preserved ejection fraction. EMPEROR-Preserved results are expected in 2021