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Finerenone significantly reduced the risk of kidney and heart outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) in the FIDELITY prespecified pooled analysis of the phase III FIDELIO-DKD and FIGARO-DKD trials. This FIDELITY subanalysis explored the efficacy and safety of finerenone in Chinese patients.
Of 13,026 patients, 697 from sites in China who self-identified as Chinese were randomised 1:1 to finerenone or placebo. Eligible patients had T2D and CKD (urine albumin-to-creatinine ratio [UACR] ≥30–<300 mg/g and estimated glomerular filtration rate [eGFR] ≥25−≤90 ml/min/1.73 m2, or UACR ≥300–≤5000 mg/g and eGFR ≥25 ml/min/1.73 m2) and were treated with optimised renin–angiotensin system inhibitor. Key outcomes were a kidney composite (kidney failure, sustained ≥57% eGFR decrease from baseline over ≥4 weeks, or renal death) and a cardiovascular (CV) composite (CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure). An additional kidney composite outcome was kidney failure, sustained ≥40% eGFR decrease from baseline over ≥4 weeks, or renal death. Safety outcomes were assessed by treatment-emergent adverse events and laboratory evaluations (e.g. serum potassium levels).
Finerenone significantly reduced the risk of the eGFR ≥57% and eGFR ≥40% kidney composite outcomes in the Chinese subgroup (hazard ratio [HR] 0.57; 95% confidence interval [CI] 0.38–0.86; p=0.0066 and HR=0.54; 95% CI 0.40–0.74; p<0.0001, respectively) vs placebo, with significant reductions on some of the components such as kidney failure (HR=0.53; 95% CI 0.33–0.86; p=0.0094). The HR of the CV composite was 0.82 (95% CI 0.52–1.29) for finerenone vs placebo, consistent with that in the overall FIDELITY population (Figure 1). Overall safety outcomes were similar between treatment arms in the Chinese subgroup and the total population, respectively. In the Chinese subgroup, hyperkalaemia leading to treatment discontinuation was low for finerenone (2.6%) and placebo (0.9%); the difference in mean serum potassium increase from baseline between finerenone and placebo was ~0.13 mmol/l from month 1 to 20.
Finerenone demonstrated heart and kidney benefits and a favorable safety profile in the FIDELITY Chinese subgroup.
This abstract was also submitted for the American Society of Nephrology 2023 Congress. By submitting the abstract to the World Congress of Nephrology 2024, abstract authors declare that resubmitting the abstract is permitted by the organisers of the previous meeting.