Patients with stage 4 chronic kidney disease (CKD) and type 2 diabetes treated with finerenone experience cardiovascular and renal benefits similar to those of patients with stage 1-3 CKD, according to findings from the FIDELITY subgroup analysis presented during the European Renal Association (ERA) 59th Congress held in Paris, France, and virtually.
The subgroup analysis, conducted by Pantelis Sarafidis, MD, of Hippokration Hospital, Aristotle University of Thessaloniki in Thessaloníki, Greece, and colleagues, examined the effects of finerenone — a nonsteroidal selective mineralocorticoid receptor antagonist — in patients with stage 4 CKD (estimated glomerular filtration rate [eGFR] less than 30 mL/min/1.73 m2) compared with stage 1-3 CKD (eGFR of 30 mL/min/1.73 m2 or higher). The patients had participated in the randomized phase 3 FIDELIO-DKD and FIGARO-DKD clinical trials of finerenone vs placebo.
FIDELITY was an individual patient-level prespecified pooled efficacy and safety analysis of these studies. Efficacy outcomes included change in urine albumin-to-creatinine ratio (UACR) from baseline to month 4, change in eGFR over time, a kidney composite outcome (kidney failure, a sustained 57% or greater decline in eGFR from baseline over 4 weeks or more or renal death), and a cardiovascular (CV) composite outcome (CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure), in addition to individual components of these composite outcomes.
The subgroup analysis included 13,023 patients, of whom 890 (6.8%) had stage 4 CKD. In these patients, finerenone reduced UACR by 31% compared with placebo between baseline and month 4, an effect maintained for the duration of the study, Dr Sarafidis’ group reported.
From trial randomization to the end of treatment, the mean eGFR declined by 0.7 mL/min/1.73 m2 per year with finerenone compared with 1.6 mL/min/1.73 m2 per year with placebo. Finerenone recipients had a 31% lower risk of a sustained 57% or greater decrease in eGFR and a 22% lower risk for the composite CV outcome. These treatment effects were consistent with those observed in other CKD groups, according to the investigators.
Hyperkalemia leading to drug discontinuation occurred in 3.2% of the finerenone group compared with 2.2% of the placebo group.
Sarafidis P, Ruilope L, Anker SD, et al. Outcomes with finerenone in patients with stage 4 chronic kidney disease and type 2 diabetes: A Fidelity subgroup analysis. Presented at: 59th ERA Congress, 2022, May 19-22, 2022, Paris, France. Abstract MO198.