Finerenone in Mild to Severe Chronic Kidney Disease and Type 2 Diabetes: A Fidelity Subgroup Analysis in Patients with Heart Failure

Patients with chronic kidney disease (CKD), type 2 diabetes (T2D), and heart failure (HF) have a very high risk of adverse cardiorenal events. FIDELITY (prespecified pooled analysis of FIDELIO-DKD [NCT02540993] and FIGARO-DKD [NCT02545049]) evaluated finerenone, a selective, nonsteroidal mineralocorticoid receptor antagonist in patients with CKD and T2D. This FIDELITY substudy analyzed the effects of finerenone in patients with and without a history of HF at baseline. Eligible patients had T2D and either a urine albumin-to-creatinine ratio (UACR [mg/g])≥30–<300 and estimated glomerular filtration rate (eGFR [mL/min/1.73m2])≥25–≤90, or UACR≥300–≤5000 and eGFR≥25, and received optimized renin–angiotensin system blockade. Key exclusion criteria included symptomatic chronic HF with reduced ejection fraction or recent HF hospitalization (HHF). Patients were randomized to finerenone or placebo. Outcomes included a cardiovascular outcome (time to cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or HHF) and a kidney outcome (kidney failure, sustained eGFR decrease≥57%, or kidney death). Investigator-reported adverse events were assessed. 1007/13,026 eligible patients had a history of HF at baseline. Primary results of the FIDELITY analysis were presented at the European Cardiology Society Congress 2021. This abstract will present detailed HF outcomes, including new onset and recurrent HF events in the total population and cardiovascular and kidney efficacy and safety results by history of HF at baseline. In FIDELITY, finerenone improved CV and kidney outcomes in patients with CKD and T2D versus placebo. The proposed analysis will provide further insights into the effects of finerenone on HF outcomes across a broad spectrum of CKD severity.