Key result
Finerenone cuts cardiovascular events ~14% in T2D and CKD, with consistent benefit across races.
Why the study?
Finerenone improved cardiorenal outcomes in patients with CKD and T2D in FIDELITY, prompting exploration of its efficacy and safety specifically in Black patients.
Does finerenone reduce the risk of cardiorenal outcomes consistently in Black and non-Black patients with chronic kidney disease and type 2 diabetes?
RCT (n=13,026)
Double-blind
1:1 ratio, stratified by region, albuminuria at screening, and eGFR
Yes
Does finerenone reduce the risk of cardiorenal outcomes consistently in Black and non-Black patients with chronic kidney disease and type 2 diabetes?
Finerenone demonstrates consistent cardiovascular and kidney benefits in both Black and non-Black patients with type 2 diabetes and CKD, despite Black patients having higher baseline disease severity.
Finerenone benefits extend to Black patients with T2D and CKD; confirms consistent cardiorenal risk reduction across races in pooled RCT data.
Rationale & Objective: In FIDELITY, finerenone improved cardiorenal outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). This analysis explored the efficacy and safety of finerenone in Black patients. Study Design: Subanalysis of randomized controlled trials. Setting & Participants: Patients with T2D and CKD. Intervention: Finerenone or placebo. Outcomes: Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure; composite of kidney failure, sustained ≥57% estimated glomerular filtration rate (eGFR) decline from baseline maintained for ≥4 weeks, or renal death. Results: 0.001], respectively). Safety outcomes were similar between subgroups. Limitations: Small number of Black patients; analysis was not originally powered to determine an interaction effect based on Black race. Conclusions: The efficacy and safety of finerenone appears consistent in Black and non-Black patients with CKD and T2D. Funding: Bayer AG. Trial Registration: ClinicalTrials.gov NCT02540993, NCT02545049. Plain-Language Summary: Diabetes is a major cause of chronic kidney disease (CKD), affecting more Black adults than White adults. Most adults with CKD ultimately die from heart and vascular complications (eg, heart attack and stroke) rather than kidney failure. This analysis of 2 recent trials shows that the drug finerenone was beneficial for patients with diabetes and CKD. Along with reducing kidney function decline and protein in the urine, it also decreased heart and vascular issues and lowered blood pressure in both Black and non-Black adults with diabetes and CKD. These findings have promising implications for slowing the progression of CKD and protecting against cardiovascular problems in diverse populations.
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Flack et al. (2023) conducted an RCT in Chronic kidney disease and type 2 diabetes (n=13,026). Finerenone vs. Matching placebo was evaluated on Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure (HR 0.86, 95% CI 0.78-0.95). Finerenone reduced the risk of the cardiovascular composite endpoint similarly in both Black (HR 0.79) and non-Black (HR 0.87) patients with type 2 diabetes and chronic kidney disease.
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