Eli Lilly and Boehringer Ingleheim have initiated the first ever study to assess Jardiance (empagliflozin) in stabilised acute heart failure. The companies announced the start of the EMPULSE trial, the sixth Phase III trial of the drug’s programme.
Lilly says that the study will assess whether in-hospital administration of Jardiance 10 mg daily improves heart failure outcomes when initiated in people hospitalised for any type of acute heart failure event, once they have been stabilised. It will also include participants both with and without type II diabetes.
Currently, outcomes for patients after they have been hospitalised for heart failure are poor, with a 15% mortality and 30% readmission rate within 60 to 90 days of discharge from the hospital.
Initiating treatment in the hospital is one of the best predictors of long-term improved prognosis and patient treatment adherence, and the EMPULSE study aims to understand whether Jardiance has the potential to improve outcomes in this population.
Acute decompensated heart failure is one of the “fastest-growing diseases in the world and a leading cause of hospital admissions worldwide with high short term mortality and rehospitalisation. Unlike chronic heart failure, there is no established therapy available that improves clinical outcomes in acute heart failure," said Adriaan Voors, professor of cardiology, University Medical Center Groningen, Netherlands.
He continued, “The beneficial effects of SGLT2 inhibitors, as seen in three large randomized trials in type II diabetes patients, are thought to be at least partly explained by the diuretic/natriuretic effects of SGLT2 inhibitors. The EMPULSE study will investigate whether Jardiance, due to its mode of action, can alleviate symptoms associated with heart failure and improve outcomes after discharge from the hospital.”
The trial is part of the overall Jardiance heart failure program, which also consists of the EMPEROR-Reduced and EMPEROR-Preserved, EMPERIAL-Preserved and EMPERIAL-Reduced, and EMPA-VISION studies, all investigating the effects of the drug on heart failure-related outcomes and functional capacity.