OXFORD, England & INGELHEIM, Germany & RIDGEFIELD, Conn. & INDIANAPOLIS, Ind.--(BUSINESS WIRE)--EMPA-KIDNEY Phase III clinical trial met its primary endpoint by demonstrating a significant kidney and cardiovascular benefit for adults living with chronic kidney disease (CKD).1,2 When treated with empagliflozin, 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<0.000001).1,2 The results were announced today 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 (NYSE: LLY). The results were also published simultaneously in The New England Journal of Medicine.2
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.1,2 CKD doubles a person’s risk for hospitalization and is a leading cause of death globally.4,5 Hospitalizations account for 35%-55% of total healthcare costs for people with CKD in the U.S.6
The overall safety data was generally consistent with previous findings, confirming the well-established safety profile of empagliflozin.
“We know that there is an urgent need for new therapies proven to delay CKD progression which can lead to the need for dialysis or transplantation. Today’s results demonstrate that empagliflozin may benefit adults at risk of progression, including those with or without diabetes, and across a wide range of kidney function,” said William Herrington, Associate Professor at MRC PHRU (part of Oxford Population Health), and Honorary Consultant Nephrologist, and EMPA-KIDNEY co-Principal Investigator. “By reducing the risk of kidney disease progression or cardiovascular death, empagliflozin has the potential to positively impact healthcare systems worldwide.”
“The design of the EMPA-KIDNEY trial included a wider range of patients than ever before,” said Professor Richard Haynes, co-Principal Investigator. “Previous SGLT2 inhibitor trials focused on certain groups of people living with CKD, such as those with diabetes or high levels of protein in their urine. Today’s positive trial results across a broad CKD population reflect an opportunity to improve the treatment of this disease and prevent people from needing dialysis.”
EMPA-KIDNEY is the largest and broadest dedicated SGLT2 inhibitor trial to date.7 It included 6,609 participants across a wide range of underlying causes, many with co-morbidities across the spectrum of cardiovascular, kidney, or metabolic conditions. The trial assessed both kidney and cardiovascular outcomes in people across the spectrum of CKD severity.8
"The Boehringer Ingelheim and Lilly Alliance is incredibly proud that EMPA-KIDNEY has provided another pivotal moment for Jardiance,” said Carinne Brouillon, Head of Human Pharma and Member of the Board of Managing Directors, Boehringer Ingelheim. “Today’s data adds to the body of evidence from our clinical program which includes more than 700,000 adults with cardiovascular, kidney and metabolic conditions. EMPA-KIDNEY reinforces the potential role of empagliflozin in changing the way these interconnected conditions may be managed.”
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.
“Today’s EMPA-KIDNEY trial results will be welcomed by people living with CKD and the medical community. We are also encouraged by the risk reduction for hospitalization after just two years, as this finding is in line with the significant reductions seen in prior Jardiance cardiovascular outcomes trials,” says Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly. “The Alliance looks forward to discussing plans for marketing authorization for CKD with regulators worldwide in due course.”
Notes to editors
Kidney disease progression: Defined as end-stage kidney disease (the initiation of maintenance dialysis or receipt of a kidney transplant), a sustained decline in estimated glomerular filtration rate (eGFR) to below 10 mL/min/1.73 m2, kidney death or a sustained decline of at least 40 percent in eGFR from randomization).
End stage kidney disease: Includes initiation of maintenance dialysis or receipt of a kidney transplant
For further information on chronic kidney disease or cardio-renal-metabolic conditions, visit: www.boehringer-ingelheim.com/chronic-kidney-disease
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