Empagliflozin and kidney outcomes in Asian patients with type 2 diabetes and established cardiovascular disease: results from the EMPA-REG OUTCOME ® trial.

AIMS/INTRODUCTION: In the EMPA-REG OUTCOME® trial, empagliflozin added to standard of care improved clinically relevant kidney outcomes by 39%, slowed progression of chronic kidney disease, and reduced albuminuria in patients with type 2 diabetes and established cardiovascular disease. This exploratory analysis investigated kidney effects of empagliflozin in Asian patients.

MATERIALS AND METHODS: Participants in EMPA-REG OUTCOME® were randomized (1:1:1) to empagliflozin 10 mg, 25 mg, or placebo. In patients of Asian race, we analyzed incident or worsening nephropathy (progression to macroalbuminuria, doubling of serum creatinine, initiation of renal-replacement therapy, or renal death) and its components, estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR) changes, and renal safety.

RESULTS: Of 7020 treated patients, 1517 (26.1%) were Asian. In this subgroup, consistent with the overall trial population, empagliflozin reduced the risk of incident or worsening nephropathy (hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.49, 0.83), progression to macroalbuminuria (HR 0.64; 95% CI 0.49, 0.85), and the composite of doubling of serum creatinine, initiation of renal-replacement therapy, or renal death (HR 0.48; 95% CI 0.25, 0.92). Furthermore, empagliflozin-treated participants demonstrated slower eGFR decline versus placebo and showed rapid UACR reduction at Week-12, maintained through Week-164, with effects most pronounced in those with baseline microalbuminuria or macroalbuminuria. The kidney safety profile of empagliflozin in the Asian subgroup was similar to the overall trial population.

CONCLUSIONS: In Asian patients from EMPA-REG OUTCOME® , empagliflozin improved kidney outcomes, slowed eGFR decline and lowered albuminuria versus placebo, consistent with the overall trial population findings. This article is protected by copyright. All rights reserved.