Jardiance reduced risk of cardiovascular death and hospitalisation for heart failure, along with serious adverse kidney outcomes in adults in Phase 3 EMPEROR-Reduced trial
Jardiance shows positive results in Phase 3 EMPEROR-Reduced trial. (Credit: Chokniti Khongchum from Pixabay.)
Boehringer Ingelheim and Eli Lilly and Co. (Lilly) announced that in an exploratory sub-analysis of the Phase 3 EMPEROR-Reduced trial, jardiance (empagliflozin) reduced the risk of adverse cardiovascular and kidney events in adults suffering with heart failure with reduced ejection fraction irrespective of diabetes status and chronic kidney disease status.
The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) programme consists of EMPEROR-Reduced, EMPEROR-Preserved, EMPERIAL-Preserved and EMPERIAL-Reduced, and EMPA-VISION trials.
The EMPEROR-Reduced programme is done on adults with chronic heart failure with reduced ejection fraction to cut down the risk of cardiovascular death or hospitalization due to heart failure.
Jardiance is a prescription medicine, granted FDA Fast Track designation for the treatment of CKD in March 2020, and to reduce the risk of cardiovascular death and hospitalisation for HF, in June 2019.
Boehringer Ingelheim Pharmaceuticals cardio-metabolism and respiratory medicine clinical development and medical affairs vice president Mohamed Eid said: “Over half of people with heart failure have moderate to severe chronic kidney disease, yet, there remains a need for new treatment options that address these interconnected conditions.
“These findings continue to show the potential of Jardiance to help improve the lives of adults living with cardio-renal-metabolic conditions, including heart failure and chronic kidney disease.”
Jardiance reduced cardiovascular risk by 25% and HF hospitalisations by 30%
EMPEROR-Reduced study showed that jardiance reduced the relative risk of cardiovascular death or hospitalisation due to HF by 25%, which is a combined endpoint.
The drug has also reduced the first and recurrent hospitalisations for HF by 30%, in addition to slowing the decline of eGFR (kidney function) in the subjects.
In an additional exploratory analysis, jardiance was shown to neutralise the relative risk of a composite kidney endpoint, including end stage kidney disease and a profound loss of kidney function, by 50%, said the company.
The results from the analysis were consistent in all subgroups of with or without chronic kidney disease patients, including those with severe renal impairment, and in all patient cohorts.
Furthermore, the safety profile in EMPEROR-Reduced trial was similar to the well-established safety profile of the drug.
Lilly product development vice president Jeff Emmick said: “Heart failure and chronic kidney disease are common, life-threatening diseases that require improved treatment options.
“The EMPOWER clinical development program, including our ongoing EMPEROR-Preserved and EMPA-KIDNEY trials, explores the potential role Jardiance may play in improving outcomes for people with these conditions. The new findings from EMPEROR-Reduced will help us achieve our goal of redefining how people living with these conditions are treated.”