Full results of EMPEROR-Reduced phase III study of empagliflozin in heart failure.-Eli Lilly + Boehringer

Full results from the EMPEROR-Reduced Phase III trial in adults with heart failure with reduced ejection fraction, with and without diabetes, showed that empagliflozin was associated with a significant 25 percent 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 empagliflozin (10 mg) versus placebo to standard of care. The results will be presented at the ESC Congress 2020, the annual meeting of the European Society of Cardiology, and published in The New England Journal of Medicine. 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 empagliflozin reduced the relative risk of first and recurrent hospitalization for heart failure by 30 percent. Additionally, the rate of decline in eGFR, a measure of kidney function decline, was slower with empagliflozin than with placebo. 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 empagliflozin decreased the relative risk of a composite kidney endpoint, including end stage kidney disease and a profound loss of kidney function, by 50 percent.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 empagliflozin. 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. The FDA has granted Fast Track designation to empagliflozin 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 empagliflozin 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 empagliflozin on the progression of kidney disease and occurrence of cardiovascular death in adults with established chronic kidney disease, with and without diabetes. See-"Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure"- Milton Packer, M.D., Stefan D. Anker, M.D., Ph.D., Javed Butler, M.D., Gerasimos Filippatos, M.D., Stuart J. Pocock, Ph.D., et al., for the EMPEROR-Reduced Trial Investigators-August 29, 2020. DOI: 10.1056/NEJMoa2022190.