Finerenone increases the likelihood of improved KDIGO risk category in patients with CKD and type 2 diabetes: An analysis from FIDELITY

IF 3.1 3区医学 Q3 ENDOCRINOLOGY & METABOLISM

Journal of diabetes and its complications Pub Date : 2026-04-01 Epub Date: 2026-01-31 DOI:10.1016/j.jdiacomp.2026.109274

Robert Weingold , Gerasimos Filippatos , Stefan D. Anker , Christoph Wanner , Tariq Shafi , Navdeep Tangri , Bertram Pitt , Meike Brinker , Charlie Scott , Luke Roberts , Peter Rossing , Silvio E. Inzucchi , FIDELIO-DKD and FIGARO-DKD Investigators

{"title":"Finerenone increases the likelihood of improved KDIGO risk category in patients with CKD and type 2 diabetes: An analysis from FIDELITY","authors":"Robert Weingold , Gerasimos Filippatos , Stefan D. Anker , Christoph Wanner , Tariq Shafi , Navdeep Tangri , Bertram Pitt , Meike Brinker , Charlie Scott , Luke Roberts , Peter Rossing , Silvio E. Inzucchi , FIDELIO-DKD and FIGARO-DKD Investigators","doi":"10.1016/j.jdiacomp.2026.109274","DOIUrl":null,"url":null,"abstract":"<div><h3>Aims</h3><div>In FIDELITY, finerenone improved kidney and cardiovascular (CV) outcomes in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). The Kidney Disease: Improving Global Outcomes (KDIGO) guidelines categorise CKD progression risk based on estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR). This FIDELITY post hoc subanalysis investigated KDIGO risk category changes associated with finerenone.</div></div><div><h3>Methods</h3><div>Improvement or worsening in KDIGO risk category was defined by variation from baseline, with specified eGFR and UACR changes. Association of these category changes with a CV composite outcome was assessed.</div></div><div><h3>Results</h3><div>Finerenone therapy led to a higher likelihood of KDIGO risk category improvement (odds ratio [OR], month 36: 1.47; 95% confidence interval [CI], 1.31–1.65; <em>p</em> < 0.0001) and lower likelihood of worsening (OR, month 36: 0.83; 95% CI, 0.77–0.90; p < 0.0001) vs. placebo. Risk category improvement reduced the CV composite outcome risk (hazard ratio [HR]: 0.82; 95% CI, 0.68–0.99; <em>p</em> = 0.043) while worsening increased this risk (HR: 1.29; 95% CI, 1.06–1.56; <em>p</em> = 0.01).</div></div><div><h3>Conclusions</h3><div>Finerenone therapy is associated with greater improvement and less worsening in KDIGO risk vs. placebo. The category changes are associated with lower risk of CV events in patients with CKD and T2D.</div></div><div><h3>Trial registration number</h3><div>FIDELIO-DKD (<span><span>NCT02540993</span><svg><path></path></svg></span>) and FIGARO-DKD (<span><span>NCT02545049</span><svg><path></path></svg></span>) are registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (funded by Bayer AG).</div></div>","PeriodicalId":15659,"journal":{"name":"Journal of diabetes and its complications","volume":"40 4","pages":"Article 109274"},"PeriodicalIF":3.1000,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of diabetes and its complications","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S105687272600019X","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/1/31 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}

引用次数: 0

Abstract

Aims

In FIDELITY, finerenone improved kidney and cardiovascular (CV) outcomes in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). The Kidney Disease: Improving Global Outcomes (KDIGO) guidelines categorise CKD progression risk based on estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR). This FIDELITY post hoc subanalysis investigated KDIGO risk category changes associated with finerenone.

Methods

Improvement or worsening in KDIGO risk category was defined by variation from baseline, with specified eGFR and UACR changes. Association of these category changes with a CV composite outcome was assessed.

Results

Finerenone therapy led to a higher likelihood of KDIGO risk category improvement (odds ratio [OR], month 36: 1.47; 95% confidence interval [CI], 1.31–1.65; p < 0.0001) and lower likelihood of worsening (OR, month 36: 0.83; 95% CI, 0.77–0.90; p < 0.0001) vs. placebo. Risk category improvement reduced the CV composite outcome risk (hazard ratio [HR]: 0.82; 95% CI, 0.68–0.99; p = 0.043) while worsening increased this risk (HR: 1.29; 95% CI, 1.06–1.56; p = 0.01).

Conclusions

Finerenone therapy is associated with greater improvement and less worsening in KDIGO risk vs. placebo. The category changes are associated with lower risk of CV events in patients with CKD and T2D.

Trial registration number

FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049) are registered with ClinicalTrials.gov (funded by Bayer AG).

Abstract Image

查看原文本刊更多论文

菲尼酮增加CKD和2型糖尿病患者改善KDIGO风险类别的可能性：来自FIDELITY的分析

目的：在FIDELITY中，finenone改善了2型糖尿病（T2D）和慢性肾脏疾病（CKD）患者的肾脏和心血管（CV）结局。肾脏疾病：改善全球结局（KDIGO）指南根据肾小球滤过率（eGFR）和尿白蛋白与肌酐比值（UACR）对CKD进展风险进行分类。这项FIDELITY事后亚分析调查了与芬烯酮相关的KDIGO风险类别变化。方法KDIGO风险类别的改善或恶化由基线的变化来定义，并指定eGFR和UACR的变化。评估这些类别变化与CV综合结果的关联。结果与安慰剂相比，芬纳酮治疗导致KDIGO风险类别改善的可能性更高（优势比[OR]，第36个月：1.47；95%可信区间[CI]， 1.31-1.65; p < 0.0001），恶化的可能性更低（OR，第36个月：0.83;95% CI, 0.77-0.90; p < 0.0001）。风险类别的改善降低了CV综合结局风险（风险比[HR]: 0.82; 95% CI, 0.68-0.99; p = 0.043），而恶化则增加了这种风险（风险比：1.29;95% CI, 1.06-1.56; p = 0.01）。结论与安慰剂相比，芬尼酮治疗在KDIGO风险方面改善更大，恶化更少。类别变化与CKD和T2D患者心血管事件风险降低相关。试验注册号fidelio - dkd （NCT02540993）和FIGARO-DKD （NCT02545049）在ClinicalTrials.gov上注册（由拜耳公司资助）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Journal of diabetes and its complications 医学-内分泌学与代谢

CiteScore

5.90

自引率

3.30%

发文量

153

审稿时长

16 days

期刊介绍： Journal of Diabetes and Its Complications (JDC) is a journal for health care practitioners and researchers, that publishes original research about the pathogenesis, diagnosis and management of diabetes mellitus and its complications. JDC also publishes articles on physiological and molecular aspects of glucose homeostasis. The primary purpose of JDC is to act as a source of information usable by diabetes practitioners and researchers to increase their knowledge about mechanisms of diabetes and complications development, and promote better management of people with diabetes who are at risk for those complications. Manuscripts submitted to JDC can report any aspect of basic, translational or clinical research as well as epidemiology. Topics can range broadly from early prediabetes to late-stage complicated diabetes. Topics relevant to basic/translational reports include pancreatic islet dysfunction and insulin resistance, altered adipose tissue function in diabetes, altered neuronal control of glucose homeostasis and mechanisms of drug action. Topics relevant to diabetic complications include diabetic retinopathy, neuropathy and nephropathy; peripheral vascular disease and coronary heart disease; gastrointestinal disorders, renal failure and impotence; and hypertension and hyperlipidemia.