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In a late-breaking abstract, investigators observed a 28% reduction in kidney disease progression or cardiovascular deaths compared to placebo.
New data from the EMPA-KIDNEY study shows empagliflozin (Jardiance) resulted in a significant reduction in kidney disease progression and cardiovascular disease mortality in patients with chronic kidney disease (CKD).
The data was presented during the 2022 American Society of Nephrology (ASN) Annual Meeting in Orlando as a late-breaking abstract.
Overall, the treatment resulted in a 28% reduction in kidney disease progression or cardiovascular deaths compared to placebo (HR, 0.72; 95% CI, 0.64-0.82; P <0.0001).
The SGLT2 inhibitor also resulted in a significant reduction in all-cause hospitalizations (14%; HR, 0.86; 95% CI, 0.78-0.95; P = 0.0025) compared to placebo.
However, reductions in hospitalizations for heart failure or cardiovascular death or all-cause death were not deemed to be statistically significant. The risk reduction in these endpoints was consistent with the totality of the evidence of from trials that did show a statistical significance in these outcomes.
The mean eGFR was 7.5 mL/min/1.73m2, including 78% of participants with an eGFR <45 mL/min/1.73m2, 48% had an urine albumin-creatinine ratio (uACR) <300 mg/g and 54% had no history of diabetus mellitus.
The EMPA-KIDNEY included 6609 patients across a wide range of underlying causes and co-morbidities in the spectrum of cardiovascular, kidney, or metabolic conditions. The investigators sought primary outcomes in both kidney and cardiovascular measures across the spectrum of chronic kidney disease severity between May 2019 and April 2021.
Each participant was randomized to either empagliflozin 10mg once daily or a matching placebo. Patients eligible for the study had an eGFR of 20 to 45 ml/min/1.73m2; or an eGFR of 45 to <90 ml/min/1.73m2 with a uACR of ≥200 mg/g and were receiving standard of care including a renin angiotensin system inhibitor, where indicated and tolerated.
The investigators sought primary outcomes of a composite of end-stage kidney disease (ESKD), a sustained eGFR <10 ml/min/1.73m2, a sustained decline in eGFR of ≥40%, or death from renal or cardiovascular causes.
Approximately 900 patients had a primary outcome, including about 250 who developed ESKD and 280 who experienced HHF or cardiovascular disease.
For safety, the results show empagliflozin was consistent in this trial with previous findings, confirming the well-established safety profile.
“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 Jardiance 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, in a statement. “By reducing the risk of kidney disease progression or cardiovascular death, Jardiance has the potential to positively impact healthcare systems worldwide.”
The study, “Empagliflozin in Patients With CKD,” was published online by ASN.