RIDGEFIELD, Conn. and INDIANAPOLIS, Aug. 29, 2020 /PRNewswire/ -- Full results from the EMPEROR-Reduced phase III trial in adults with heart failure with reduced ejection fraction, with and without diabetes, showed that Jardiance® (empagliflozin) was associated with a significant 25% relative risk reduction in the primary endpoint of time to cardiovascular death or hospitalization due to heart failure. The trial evaluated the effect of adding Jardiance (10 mg) versus placebo to standard of care. The results will be presented today at the ESC Congress 2020, the annual meeting of the European Society of Cardiology, and published in The New England Journal of Medicine, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.
The findings from the primary endpoint were consistent in subgroups with and without type 2 diabetes. Key secondary endpoint analyses from the trial demonstrated that Jardiance reduced the relative risk of first and recurrent hospitalization for heart failure by 30%. Additionally, the rate of decline in eGFR, a measure of kidney function decline, was slower with Jardiance than with placebo.
"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," said Milton Packer, M.D., Chair of the Executive Committee for the EMPEROR Program and Distinguished Scholar in Cardiovascular Science at Baylor University Medical Center in Dallas. "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."
In an exploratory analysis, the absolute risk reduction observed in the primary endpoint of EMPEROR-Reduced corresponded to a number needed to treat of 19 patients over 16 months to prevent one cardiovascular death or hospitalization for heart failure. An additional exploratory analysis showed that Jardiance decreased the relative risk of a composite kidney endpoint*, including end stage kidney disease and a profound loss of kidney function, by 50%.
In EMPEROR-Reduced, the efficacy results were achieved with a simple dosing regimen, with once daily dosing and no need for titration. The safety profile was similar to the well-established safety profile of Jardiance. There were no clinically meaningful differences in adverse events, including hypovolemia (decreased blood volume), hypotension (low blood pressure), volume depletion (loss of fluids), renal insufficiency (poor kidney function), hyperkalemia (high potassium levels) or hypoglycemic events (low blood sugar) compared with placebo.
Heart failure affects over 60 million people worldwide, with more than one million people being hospitalized due to the condition every year in the U.S. Heart failure occurs when the heart cannot pump sufficient blood to the rest of the body and is the most common and severe complication of a heart attack. People with heart failure often experience breathlessness and fatigue, which can severely impact their quality of life. Individuals with heart failure often also have impaired kidney function, which can have a significant negative impact on prognosis.
"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, M.D., M.P.H, M.H.A, 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."
"Tens of millions of people live with heart failure and kidney disease," said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly. "Results from EMPEROR-Reduced show that Jardiance can help improve heart failure outcomes while also slowing kidney function decline. We are excited to share these data and, through our ongoing EMPOWER program, hope to redefine how people living with these conditions are treated."
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Jardiance for the reduction of the risk of cardiovascular death and hospitalization for heart failure in people with heart failure. This designation is for the EMPEROR program, which consists of the EMPEROR-Reduced and EMPEROR-Preserved trials. EMPEROR-Preserved is exploring the effect of Jardiance on cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction, an area that currently has no approved treatment options. EMPEROR-Preserved results are expected in 2021.
Additionally, the ongoing EMPA-KIDNEY study is evaluating the effect of Jardiance on the progression of kidney disease and occurrence of cardiovascular death in adults with established chronic kidney disease, with and without diabetes. The FDA has also granted Fast Track designation to Jardiance for the treatment of chronic kidney disease, demonstrating the urgent need for new treatment options for people living with the condition worldwide. Results from EMPA-KIDNEY are expected in 2022.