Author:
Koya Daisuke,Anker Stefan D.,Ruilope Luis M.,Rossing Peter,Liu ZhiHong,Lee Byung Wan,Lee Chien-Te,Scott Charlie,Kolkhof Peter,Lawatscheck Robert,Wang Lili,Joseph Amer,Pitt Bertram,
Abstract
<b><i>Introduction:</i></b> In FIDELIO-DKD, finerenone significantly improved cardiorenal outcomes in patients with chronic kidney disease and type 2 diabetes (T2D). This post hoc analysis explores finerenone in patients from the Asian region. <b><i>Methods:</i></b> In FIDELIO-DKD, 5,674 patients with T2D and urine albumin-to-creatinine ratio (UACR) ≥30–<300 mg/g and estimated glomerular filtration rate (eGFR) ≥25–<60 mL/min/1.73 m<sup>2</sup> or UACR ≥300–≤5,000 mg/g and eGFR ≥25–<75 mL/min/1.73 m<sup>2</sup>, treated with optimized renin-angiotensin system blockade, were randomized 1:1 to finerenone or placebo. Efficacy outcomes included a primary kidney composite (time to kidney failure, sustained decrease of ≥40% in eGFR from baseline, and death from renal causes) and secondary cardiovascular (CV) (time to CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure) and kidney (time to kidney failure, sustained decrease of ≥57% in eGFR from baseline, and death from renal causes) composites. <b><i>Results:</i></b> Of 1,327 patients in the Asian subgroup, 665 received finerenone. Finerenone reduced the ≥40% and ≥57% eGFR kidney and CV composite outcomes versus placebo in the Asian subgroup (hazard ratio [HR]: 0.70; 95% confidence interval [CI]: 0.56–0.87, HR: 0.73; 95% CI: 0.55–0.97, and HR: 0.85; 95% CI: 0.59–1.21, respectively), with no apparent differences versus patients from the rest of the world (HR: 0.88; 95% CI: 0.77–1.02; <i>p</i> interaction 0.09, HR: 0.78; 95% CI: 0.64–0.95; <i>p</i> interaction 0.71, and HR: 0.86; 95% CI: 0.74–1.00; <i>p</i> interaction 0.95, respectively). The safety profile of finerenone was similar across subgroups. <b><i>Conclusion:</i></b> Finerenone produces similar cardiorenal benefits in Asian and non-Asian patients.
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