Finerenone in patients with CKD and T2D with and without heart failure: A prespecified subgroup analysis of the FIDELIO-DKD trial

Abstract

Aims This prespecified analysis of the FIDELIO-DKD trial compared the effects of finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, on cardiorenal outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) by history of heart failure (HF).

Methods Patients with T2D and CKD (urine albumin-to-creatinine ratio ≥ 30–5000 mg/g and estimated glomerular filtration rate (eGFR) ≥25–<75 mL/min/1.73 m2), without symptomatic HF with reduced ejection fraction (New York Heart Association II–IV) and treated with optimized renin–angiotensin system blockade were randomized to finerenone or placebo. The composite cardiovascular (CV) outcome (CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for HF) and composite kidney outcome (kidney failure, sustained ≥40% decrease in eGFR from baseline, or renal death) were analysed by investigator-reported medical history of HF.

Results Of 5674 patients, 436 (7.7%) had a history of HF. Over a median follow-up of 2.6 years, the effect of finerenone compared with placebo on the composite CV outcome was consistent in patients with and without a history of HF (hazard ratio [HR] 0.73 [95% confidence interval (CI) 0.50–1.06] and 0.90 [95% CI 0.77–1.04], respectively; interaction P = 0.33). The effect of finerenone on the composite kidney outcome did not differ by history of HF (HR 0.79 [95% CI 0.52–1.20] and 0.83 [95% CI 0.73–0.94], respectively; interaction P = 0.83).

Conclusion In FIDELIO-DKD, finerenone improved cardiorenal outcome in patients with CKD and T2D irrespective of baseline HF history.