Finerenone and Clinical Outcomes in CKD and Type 2 Diabetes by Frailty Index. FIDELITY Post Hoc Analysis
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Fecha
2025
Autores
Rossing, Peter
Birkenfeld, Andreas L.
Fioretto, Paola
McGill, Janet B.
Anker, Stefan D.
Pitt, Bertram
Rohwedder, Katja
Scalise, Andrea
Scott, Charlie
Filippatos, Gerasimos
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American Society of Nephrology
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Background Frailty is associated with a higher risk of adverse outcomes. It is believed that people with a higher frailty
index (FI) may be less tolerant to new treatments, often leading to inappropriate prescribing. This post hoc analysis of
FInerenone in chronic kiDney diseasE and type 2 diabetes: Combined FInerenone in reducing kiDnEy faiLure and dIsease
prOgression in Diabetic Kidney Disease (FIDELIO-DKD) and FIGARO-DKD Trial program analysis, a prespecified,
pooled analysis of the FIDELIO-DKD and FIGARO-DKD phase 3 clinical trials, investigated the efficacy and safety of
finerenone versus placebo according to baseline FI.
Methods Between September 2015 and October 2018, 12,990 people with CKD and type 2 diabetes receiving the maximum
tolerated dose of a renin-angiotensin system inhibitor were randomized to receive finerenone 10 or 20 mg once daily or
placebo. Baseline FI was calculated using the Rockwood cumulative deficit approach including 30 clinical characteristics.
Primary efficacy outcomes included a kidney (kidney failure, sustained decrease of $57% in eGFR, or kidney-related death)
and a cardiovascular (CV) composite outcome (CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization
for heart failure). Changes in urine albumin-to-creatinine ratio and eGFR were measured across the study period.
Results Overall, kidney and CV event rates increased with increasing frailty. Finerenone reduced the risk of primary
kidney and CV composite outcomes irrespective of baseline frailty (P interaction 5 0.93 and 0.35, respectively). Compared
with placebo, finerenone also demonstrated significant reductions in urine albumin-to-creatinine ratio across all frailty
subgroups (P , 0.01 for all visits) and significant attenuation of eGFR decline from baseline to month 48 in the three most
frail quartiles (.Q1 to #Q2, P 5 0.001; .Q2 to #Q3, P , 0.001; .Q3, P , 0.001, respectively). The incidence of serious
adverse events and hyperkalemia increased with increasing frailty in both treatment arms.
Conclusions Finerenone reduced the risk of CV and kidney events in people with CKD and type 2 diabetes versus placebo
irrespective of baseline frailty status.
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Rossing, Peter1,2; Birkenfeld, Andreas L.3,4,5; Fioretto, Paola6; McGill, Janet B.7; Anker, Stefan D.8,9; Pitt, Bertram10; Rohwedder, Katja11; Scalise, Andrea12; Scott, Charlie13; Filippatos, Gerasimos14; on behalf of the FIDELIO-DKD and FIGARO-DKD Investigators. Finerenone and Clinical Outcomes in CKD and Type 2 Diabetes by Frailty Index: FIDELITY Post Hoc Analysis. Clinical Journal of the American Society of Nephrology ():10.2215/CJN.0000000700, May 2, 2025. | DOI: 10.2215/CJN.0000000700
