Finerenone may offer cardiovascular benefits in patients with type 2 diabetes and stage 4 chronic kidney disease who have a baseline estimated glomerular filtration rate as low as 25 mL/min/1.73 m2, investigators reported.

Finerenone, a selective, nonsteroidal mineralocorticoid receptor antagonist, blocks mineralocorticoid receptor overactivation.

Pantelis Sarafidis, MD, MSc, PhD, of Hippokration Hospital, Aristotle University of Thessaloniki in Greece, and colleagues conducted a subgroup analysis of 890 of 13,023 patients (7%) from the FIDELITY pooled dataset who had stage 4 diabetic kidney disease. In this subgroup, 17% experienced a cardiovascular event and 21% experienced a kidney event.

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The time to first onset of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure was a nonsignificant 22% lower among patients randomly assigned to finerenone versus placebo, the investigators reported in the Clinical Journal of the American Society of Nephrology. They found a similar but significant 13% reduction in the composite cardiovascular outcome among patients with stage 1-3 kidney disease.

Finerenone did not significantly reduce the risk of the composite kidney outcome (kidney failure, sustained 57% or greater decrease in eGFR from baseline, or kidney disease death), the investigators reported. However, the decline in the chronic eGFR slope was significantly lower with finerenone compared with placebo: -1.77 vs -3.15 mL/min/1.73 m2, respectively. Finerenone recipients also had significantly less albuminuria than placebo recipients over 24 months.

“Further research is warranted as the effect of finerenone on the composite kidney outcome in participants with stage 4 CKD was inconsistent in early versus late years of follow-up, with a notable loss of precision over time,” Dr Sarafidis’ team wrote.

Finerenone, however, consistently showed improvements in markers of kidney injury, as indicated by a reduction in urinary albumin-to-creatinine ratio, and function (better preservation of eGFR in the chronic phase) compared with placebo in patients with stage 4 CKD.

“These findings suggest that finerenone could provide cardiovascular benefits in participants with stage 4 CKD and type 2 diabetes, while also reducing albuminuria and the rate of eGFR decline.”

Hyperkalemia occurred in 26% of the finerenone group compared with 13% of the placebo group, but it rarely led to treatment discontinuation (3% vs 2%, respectively) or hospitalization (3% vs 1%, respectively). The investigators recommended that clinicians monitor serum potassium levels and take steps to reduce hyperkalemia risk, such as using potassium-lowering agents. Overall rates of adverse events were similar between groups.

Disclosure: This research was supported by Bayer. Please see the original reference for a full list of disclosures.


Sarafidis P, Agarwal R, Pitt B, et al. Outcomes with finerenone in participants with stage 4 CKD and type 2 diabetes: A FIDELITY subgroup analysis. Clin J Am Soc Nephrol. Published online March 17, 2023. doi:10.2215/CJN.0000000000000149