Finerenone in Black Patients With Type 2 Diabetes and CKD: A Post hoc Analysis of the Pooled FIDELIO-DKD and FIGARO-DKD Trials

Abstract

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: Of the 13,026 patients, 522 (4.0%) self-identified as Black. Finerenone demonstrated similar effects on the cardiovascular composite outcome in Black (HR, 0.79 [95% CI, 0.51-1.24]) and non-Black patients (HR, 0.87 [95% CI, 0.79-0.96; P = 0.5 for interaction]). Kidney composite outcomes were consistent in Black (HR, 0.71 [95% CI, 0.43-1.16]) and non-Black patients (HR, 0.76 [95% CI, 0.66-0.88; P = 0.9 for interaction]). Finerenone reduced urine albumin-to-creatinine ratio by 40% at month 4 (least-squares mean treatment ratio, 0.60 [95% CI, 0.52-0.69; P < 0.001]) in Black patients and 32% at month 4 (least-squares mean treatment ratio, 0.68 [95% CI, 0.66-0.70; P < 0.001]) in non-Black patients, versus placebo. Chronic eGFR decline (month 4 to end-of-study) was slowed in Black and non-Black patients treated with finerenone versus placebo (between-group difference, 1.4 mL/min/1.73 m² per year [95% CI, 0.33-2.44; P = 0.01] and 1.1 mL/min/1.73 m² per year [95% CI, 0.89-1.28; P < 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.

Keywords: Cardiorenal; chronic kidney disease; clinical trial; finerenone; race; type 2 diabetes.

Graphical abstract

Figure 1

Analysis of cardiovascular and kidney composite outcomes in Black and non-Black patients. eGFR, estimated glomerular filtration rate; HR, hazard ratio; PY, patient-years. ^aThe composite of time to first onset of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. ^bThe composite of time to first onset of kidney failure, sustained ≥57% decrease in eGFR from baseline maintained for ≥4 weeks, or renal death.

Figure 2

Change in UACR over time in Black and non-Black patients.^a LS, least-squares; UACR, urine albumin-to-creatinine ratio. ^aMixed model.

Figure 3

Chronic eGFR slope from month 4 to end-of-study in Black and non-Black patients. eGFR, estimated glomerular filtration rate; LS, least-squares.