Boehringer Ingelheim and Eli Lilly have reported positive top-line data from the Phase III EMPEROR-Reduced clinical trial of Jardiance (empagliflozin) in adults with reduced ejection fraction heart failure, with and without diabetes.
The trial met its primary endpoint, where the drug showed superiority over placebo in mitigating the risk for the composite of cardiovascular death or hospitalisation related to heart failure, when given with standard of care.
Overall the safety profile was observed to be similar to the drug’s known profile.
Boehringer Ingelheim Pharmaceuticals Cardio-Metabolism & Respiratory Medicine clinical development & medical affairs vice-president Mohamed Eid said: “With these positive top-line results from the EMPEROR-Reduced trial, we are excited to mark another important advancement for Jardiance.
“There is an urgent need for new heart failure treatments, and these results show promise for the potential role Jardiance can play in improving the lives of adults living with this condition.”
Jardiance is a prescription drug indicated for use with a healthy diet and exercise to lower blood sugar in adults with type 2 diabetes.
The drug is also used to decrease the risk of cardiovascular death in type 2 diabetes patients with known cardiovascular disease.
EMPEROR-Reduced assessed the safety and efficacy of Jardiance in patients with heart failure with reduced ejection fraction in a total of 3,730 patients.
The study is part of the EMPEROR Heart Failure Studies, including EMPEROR-Preserved, which is investigating the safety and efficacy of Jardiance in around 5,990 patients with preserved ejection fraction heart failure.
Results from EMPEROR-Preserved are expected to be reported next year.
The EMPEROR trials fall under the EMPOWER clinical programme, which is assessing the impact of the drug on the lives of people with a variety of cardio-renal-metabolic conditions.
In May this year, Boehringer and Lilly partnered with the Duke Clinical Research Institute (DCRI) to conduct the EMPACT-MI trial of Jardiance to prevent heart failure.