EMPA-KIDNEY phase III clinical trial of Jardiance meets primary endpoint in chronic kidney disease with results announced at Kidney Week and published in NEJM.- Eli Lilly + Boehringer.

When treated with Jardiance (empagliflozin), from Eli Lilly, the risk of kidney disease progression or cardiovascular death was significantly reduced by 28% vs. placebo (HR; 0.72; 95% CI 0.64 to 0.82; P<0.0001). reductions in other key secondary endpoints of hospitalization for heart failure or cardiovascular death or all-cause death were not statistically significant, however the power to detect this was limited by the number of events observed. reduction in the risk of these endpoints is consistent with the totality of the evidence from other trials which have shown statistical significance of these outcomes. the overall safety data was generally consistent with previous findings, confirming the well-established safety profile of jardiance.></0.0001).>

The results were announced during the American Society of Nephrology (ASN)'s Kidney Week 2022 by the Medical Research Council Population Health Research Unit (MRC PHRU) at the University of Oxford, which designed, conducted and analyzed EMPA-KIDNEY in a scientific collaboration with Boehringer Ingelheim and Eli Lilly and Company. The results were also published simultaneously in The New England Journal of Medicine.

EMPA-KIDNEY is the first SGLT2 inhibitor CKD trial to demonstrate a significant reduction in all-cause hospitalizations (14%) (HR; 0.86; 95% CI 0.78 to 0.95; p=0.0025) vs. placebo, one of the pre-specified key secondary confirmatory endpoints. CKD doubles a person's risk for hospitalization and is a leading cause of death globally. Hospitalisations account for 35%-55% of total healthcare costs for people with CKD in the U.S.

See: "Empagliflozin in Patients with Chronic Kidney Disease" The EMPA-KIDNEY Collaborative Group, NEJM November 4, 2022 DOI: 10.1056/NEJMoa2204233