Eli Lilly’s Diabetes Drug Jardiance Helps Heart Failure, Too

Eli Lilly recently announced positive Phase 3 clinical trial results for its type 2 diabetes drug, Jardiance, when used by adults with heart failure with reduced ejection fraction. 

The trial, EMPEROR-Reduced, found that Jardiance was associated with a 25 percent relative risk reduction in the primary endpoint, which was time to cardiovascular death or hospitalization due to heart failure. 

Additionally, Jardiance reduced the relative risk of first and recurrent hospitalization for heart failure by 30 percent.

And the rate of decline in estimated glomerular filtration rate (eGFR), a measure of kidney function decline, was slower with Jardiance than with placebo, researchers highlighted.

These findings were consistent in subgroups with or without type 2 diabetes.

"Heart failure is a devastating and debilitating cardiovascular condition. Not only does it limit quality of life, but it is also a progressive disease that requires repeated hospitalizations and is accompanied by a loss in kidney function," Milton Packer, MD, chair of the executive committee for the EMPEROR program and distinguished scholar in cardiovascular science at Baylor University Medical Center, said in the announcement.

"Results from the EMPEROR-Reduced trial show that, when given to adults with heart failure with reduced ejection fraction, empagliflozin reduces the number of heart failure hospitalizations while slowing the decline of kidney function. These results are highly statistically significant and clinically important."

Researchers gave patients either 10 milligrams of Jardiance, a placebo, or standard care.

An additional analysis found that Jardiance decreased the relative risk of end-stage kidney disease and loss of kidney function by 50 percent, researchers said

"Jardiance transformed the treatment paradigm as the first and only oral diabetes medicine proven to significantly reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, based on the EMPA-REG OUTCOME trial," said Mohamed Eid, MD, MPH, MHA, vice president, clinical development & medical affairs, cardio-metabolism & respiratory medicine, Boehringer Ingelheim Pharmaceuticals, Inc. 

"The positive results from EMPEROR-Reduced build on this legacy and demonstrate the potential of Jardiance to improve cardiovascular outcomes and slow kidney function decline in adults with heart failure, with and without diabetes. We look forward to submitting these data to regulatory authorities later this year."

Recently, FDA granted Fast Track designation to Jardiance for the reduction of the risk of cardiovascular death and hospitalization for heart failure, Lilly said.

Specifically, the designation was granted to the EMPEROR program, which includes the EMPEROR-Reduced and EMPEROR-Preserved trials.

Currently, EMPEROR-Preserved is exploring the effect of Jardiance on cardiovascular death or hospitalization for heart failure in adults with this condition, along with preserved ejection fraction.

This is an area that has no approved treatment options. Lilly stated that the EMPEROR-Preserved results are expected in 2021.

Additionally, FDA granted Fast Track designation to Jardiance for the treatment of chronic kidney disease due to the urgent need for new treatment options for people living with the condition worldwide. 

Eli Lilly noted an ongoing study that is evaluating the effect of Jardiance on the progression of kidney diseases and occurrence of cardiovascular death in adults with chronic kidney disease.

Results from the study, EMPA-KIDNEY, are expected in 2022. 

The EMPEROR and EMPA-KIDNEY studies are part of the EPOWER clinical program.

This program is the most comprehensive study currently exploring Jardiance in individuals across the spectrum, an Eli Lilly spokesperson stated.

The program also includes the EMPACT-MI study and EMPULSE study.

The EMPACT-MI study will investigate the effect of Jardiance on mortality and hospitalization for heart failure in adults with and without diabetes. And the EMPULSE study will explore Jardiance in adults with and without diabetes, who are hospitalized for acute heart failure.