Finerenone and Clinical Outcomes in CKD and Type 2 Diabetes by Frailty Index: FIDELITY Post Hoc Analysis.
Publication/Presentation Date
5-2-2025
Abstract
KEY POINTS: Frailty is associated with a higher risk of adverse outcomes in people with CKD and type 2 diabetes. Finerenone reduced the risk of kidney and cardiovascular outcomes irrespective of baseline frailty. Finerenone was well tolerated; the relative risk of adverse events remained consistent between treatment arms across the frailty subgroups.
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
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 (
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.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER:: FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049).
Volume
20
Issue
7
First Page
968
Last Page
977
ISSN
1555-905X
Published In/Presented At
Rossing, P., Birkenfeld, A. L., Fioretto, P., McGill, J. B., Anker, S. D., Pitt, B., Rohwedder, K., Scalise, A., Scott, C., Filippatos, G., & FIDELIO-DKD and FIGARO-DKD Investigators (2025). 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 : CJASN, 20(7), 968–977. https://doi.org/10.2215/CJN.0000000700
Disciplines
Medicine and Health Sciences
PubMedID
40315020
Department(s)
Department of Medicine
Document Type
Article