Takashi Wada, Stefan D Anker, Zhihong Liu, Byung Wan Lee, Chien-Te Lee, Peter Rossing, Luis M Ruilope, Christiane Ahlers, Meike Brinker, Amaninder Mann, Satoshi Yamashita, Bertram Pitt
{"title":"菲尼酮治疗亚洲2型糖尿病和慢性肾病患者的疗效和安全性：一项FIDELITY分析","authors":"Takashi Wada, Stefan D Anker, Zhihong Liu, Byung Wan Lee, Chien-Te Lee, Peter Rossing, Luis M Ruilope, Christiane Ahlers, Meike Brinker, Amaninder Mann, Satoshi Yamashita, Bertram Pitt","doi":"10.1159/000545415","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>In FIDELITY, a prespecified pooled analysis of the phase III FIDELIO-DKD and FIGARO-DKD trials, finerenone reduced the risk of cardiovascular (CV) and kidney events versus placebo in patients with type 2 diabetes and chronic kidney disease, on optimized renin-angiotensin system blockade. This FIDELITY post hoc subanalysis explores the efficacy and safety of finerenone in Asian patients.</p><p><strong>Methods: </strong>For this subanalysis, efficacy outcomes included a CV composite (time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) and kidney composite (kidney failure, sustained ≥57% estimated glomerular filtration rate [eGFR] decrease from baseline over ≥4 weeks or renal death) outcome. A change in urine albumin-to-creatinine ratio (UACR) from baseline to month 4 and eGFR slopes was also assessed. All outcomes were assessed by baseline eGFR (<60 and ≥60 mL/min/1.73 m<sup>2</sup>) and UACR (<300 and ≥300 mg/g) subgroups. Safety outcomes were reported as treatment-emergent adverse events, including laboratory evaluations for hyperkalemia.</p><p><strong>Results: </strong>In the Asian subpopulation, 1,412/2,858 (49.4%) received finerenone. Finerenone-treated Asian patients had a lower risk of the composite CV outcome (hazard ratio [HR] = 0.90; 95% confidence interval [CI], 0.70-1.15) and nominally significant reductions in the risk of ≥57% and ≥40% eGFR composite kidney outcomes (HR = 0.64; 95% CI, 0.50-0.82 and HR = 0.67; 95% CI, 0.56-0.80, respectively) versus those receiving placebo, irrespective of baseline eGFR and UACR. Data on change of eGFR from baseline over the course of the trials indicated that chronic kidney disease progression in Asian patients was slower with finerenone versus placebo. Overall, safety outcomes were balanced between both populations. Serum potassium values with finerenone were similar between the Asian and non-Asian subpopulations (>5.5 mmol/L: 15.6% versus 17.1%; >6.0 mmol/L: 4.6% versus 2.9%, respectively), while hyperkalemia leading to permanent treatment discontinuation with finerenone was low in both populations (Asian: 1.5%; non-Asian: 1.8%).</p><p><strong>Conclusion: </strong>Finerenone reduced the risk of CV and kidney events and demonstrated a well-tolerated safety profile in the FIDELITY Asian subpopulation.</p>","PeriodicalId":17830,"journal":{"name":"Kidney Diseases","volume":"11 1","pages":"402-415"},"PeriodicalIF":3.2000,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12185061/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of Finerenone in Asian Patients with Type 2 Diabetes and Chronic Kidney Disease: A FIDELITY Analysis.\",\"authors\":\"Takashi Wada, Stefan D Anker, Zhihong Liu, Byung Wan Lee, Chien-Te Lee, Peter Rossing, Luis M Ruilope, Christiane Ahlers, Meike Brinker, Amaninder Mann, Satoshi Yamashita, Bertram Pitt\",\"doi\":\"10.1159/000545415\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>In FIDELITY, a prespecified pooled analysis of the phase III FIDELIO-DKD and FIGARO-DKD trials, finerenone reduced the risk of cardiovascular (CV) and kidney events versus placebo in patients with type 2 diabetes and chronic kidney disease, on optimized renin-angiotensin system blockade. This FIDELITY post hoc subanalysis explores the efficacy and safety of finerenone in Asian patients.</p><p><strong>Methods: </strong>For this subanalysis, efficacy outcomes included a CV composite (time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) and kidney composite (kidney failure, sustained ≥57% estimated glomerular filtration rate [eGFR] decrease from baseline over ≥4 weeks or renal death) outcome. A change in urine albumin-to-creatinine ratio (UACR) from baseline to month 4 and eGFR slopes was also assessed. All outcomes were assessed by baseline eGFR (<60 and ≥60 mL/min/1.73 m<sup>2</sup>) and UACR (<300 and ≥300 mg/g) subgroups. Safety outcomes were reported as treatment-emergent adverse events, including laboratory evaluations for hyperkalemia.</p><p><strong>Results: </strong>In the Asian subpopulation, 1,412/2,858 (49.4%) received finerenone. Finerenone-treated Asian patients had a lower risk of the composite CV outcome (hazard ratio [HR] = 0.90; 95% confidence interval [CI], 0.70-1.15) and nominally significant reductions in the risk of ≥57% and ≥40% eGFR composite kidney outcomes (HR = 0.64; 95% CI, 0.50-0.82 and HR = 0.67; 95% CI, 0.56-0.80, respectively) versus those receiving placebo, irrespective of baseline eGFR and UACR. Data on change of eGFR from baseline over the course of the trials indicated that chronic kidney disease progression in Asian patients was slower with finerenone versus placebo. Overall, safety outcomes were balanced between both populations. 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Efficacy and Safety of Finerenone in Asian Patients with Type 2 Diabetes and Chronic Kidney Disease: A FIDELITY Analysis.
Introduction: In FIDELITY, a prespecified pooled analysis of the phase III FIDELIO-DKD and FIGARO-DKD trials, finerenone reduced the risk of cardiovascular (CV) and kidney events versus placebo in patients with type 2 diabetes and chronic kidney disease, on optimized renin-angiotensin system blockade. This FIDELITY post hoc subanalysis explores the efficacy and safety of finerenone in Asian patients.
Methods: For this subanalysis, efficacy outcomes included a CV composite (time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) and kidney composite (kidney failure, sustained ≥57% estimated glomerular filtration rate [eGFR] decrease from baseline over ≥4 weeks or renal death) outcome. A change in urine albumin-to-creatinine ratio (UACR) from baseline to month 4 and eGFR slopes was also assessed. All outcomes were assessed by baseline eGFR (<60 and ≥60 mL/min/1.73 m2) and UACR (<300 and ≥300 mg/g) subgroups. Safety outcomes were reported as treatment-emergent adverse events, including laboratory evaluations for hyperkalemia.
Results: In the Asian subpopulation, 1,412/2,858 (49.4%) received finerenone. Finerenone-treated Asian patients had a lower risk of the composite CV outcome (hazard ratio [HR] = 0.90; 95% confidence interval [CI], 0.70-1.15) and nominally significant reductions in the risk of ≥57% and ≥40% eGFR composite kidney outcomes (HR = 0.64; 95% CI, 0.50-0.82 and HR = 0.67; 95% CI, 0.56-0.80, respectively) versus those receiving placebo, irrespective of baseline eGFR and UACR. Data on change of eGFR from baseline over the course of the trials indicated that chronic kidney disease progression in Asian patients was slower with finerenone versus placebo. Overall, safety outcomes were balanced between both populations. Serum potassium values with finerenone were similar between the Asian and non-Asian subpopulations (>5.5 mmol/L: 15.6% versus 17.1%; >6.0 mmol/L: 4.6% versus 2.9%, respectively), while hyperkalemia leading to permanent treatment discontinuation with finerenone was low in both populations (Asian: 1.5%; non-Asian: 1.8%).
Conclusion: Finerenone reduced the risk of CV and kidney events and demonstrated a well-tolerated safety profile in the FIDELITY Asian subpopulation.
期刊介绍：
''Kidney Diseases'' aims to provide a platform for Asian and Western research to further and support communication and exchange of knowledge. Review articles cover the most recent clinical and basic science relevant to the entire field of nephrological disorders, including glomerular diseases, acute and chronic kidney injury, tubulo-interstitial disease, hypertension and metabolism-related disorders, end-stage renal disease, and genetic kidney disease. Special articles are prepared by two authors, one from East and one from West, which compare genetics, epidemiology, diagnosis methods, and treatment options of a disease.
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