학술논문
Finerenone in Black Patients With Type 2 Diabetes and CKD: A Post hoc Analysis of the Pooled FIDELIO-DKD and FIGARO-DKD Trials.
Document Type
Academic Journal
Author
Flack JM; Department of Medicine, Division of General Internal Medicine, Hypertension Section Southern Illinois University School of Medicine, Illinois, IL.; Agarwal R; Richard L. Roudebush VA Medical Center and Indiana University, Indianapolis, IN.; Anker SD; Department of Cardiology (CVK) of German Heart Center Charité; Institute of Health Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) partner site Berlin, Charité Universitätsmedizin, Berlin, Germany.; Pitt B; Department of Medicine, University of Michigan School of Medicine, Ann Arbor, MI.; Ruilope LM; Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain.; CIBER-CV, Hospital Universitario 12 de Octubre, Madrid, Spain.; Faculty of Sport Sciences, European University of Madrid, Madrid, Spain.; Rossing P; Steno Diabetes Center Copenhagen, Gentofte, Denmark.; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.; Adler SG; Division of Nephrology and Hypertension, Harbor-UCLA Medical Center, Torrance, CA.; Fried L; Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.; Jamerson K; Cardiology Clinic, University of Michigan, Ann Arbor, Michigan, MI.; Toto R; Department of Internal Medicine, University of Texas Southwestern Medicine, Dallas, TX.; Brinker M; Cardiology and Nephrology Clinical Development, Bayer AG, Wuppertal, Germany.; Farjat AE; Research and Development, Statistics and Data Insights, Bayer PLC, Reading, United Kingdom.; Kolkhof P; Research and Development Cardiovascular Precision Medicines, Bayer AG, Wuppertal, Germany.; Lawatscheck R; Cardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany.; Joseph A; Cardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany.; Bakris GL; Department of Medicine, University of Chicago Medicine, Chicago, IL.
Source
Publisher: Elsevier Inc Country of Publication: United States NLM ID: 101756300 Publication Model: eCollection Cited Medium: Internet ISSN: 2590-0595 (Electronic) Linking ISSN: 25900595 NLM ISO Abbreviation: Kidney Med Subsets: PubMed not MEDLINE
Subject
Language
English
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 m 2 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.
(© 2023 The Authors.)
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 m
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.
(© 2023 The Authors.)