Finerenone in Black Patients With Type 2 Diabetes and CKD: A Post hoc Analysis of the Pooled FIDELIO-DKD and FIGARO-DKD Trials
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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.
| Originalsprog | Engelsk |
|---|---|
| Artikelnummer | 100730 |
| Tidsskrift | Kidney Medicine |
| Vol/bind | 5 |
| Udgave nummer | 12 |
| Antal sider | 11 |
| ISSN | 2590-0595 |
| DOI | |
| Status | Udgivet - 2023 |
Bibliografisk note
Funding Information:
The authors and study sponsor are indebted to the patients and their families, and the investigators and sites participating in the studies. Medical writing assistance was provided by Emilie Topley, of Chameleon Communications International, and was funded by Bayer AG.
Funding Information:
This work was supported by Bayer AG , which funded the FIDELIO-DKD and FIGARO-DKD studies, the combined FIDELITY analysis, and additional subanalyses. A full list of the FIDELIO-DKD and FIGARO-DKD study investigators is included in the supplementary materials. The executive committee designed the studies in conjunction with Bayer AG. Employees from Bayer AG were involved in the study design; the collection, analysis, and interpretation of data; writing the report; and the decision to submit the report for publication. Dr Toto’s contribution to this work is supported by the endowments from the Mary M. Conroy Professorship and the Houston J and Florence A. Doswell Center for the Development of New Approaches for the Treatment of Hypertension.
Publisher Copyright:
© 2023 The Authors
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