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Efficacy and safety of finerenone in patients with an acute change in estimated glomerular filtration rate in the prespecified FIDELITY pool analysis

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Title: Efficacy and safety of finerenone in patients with an acute change in estimated glomerular filtration rate in the prespecified FIDELITY pool analysis
Authors: Sankar D. Navaneethan, Stefan D. Anker, Gerasimos Filippatos, Bertram Pitt, Peter Rossing, Luis M. Ruilope, Phyllis August, Meike Brinker, Andrea Lage, Luke Roberts, Charlie Scott, Pantelis Sarafidis
Source: Navaneethan, S D, Anker, S D, Filippatos, G, Pitt, B, Rossing, P, Ruilope, L M, August, P, Brinker, M, Lage, A, Roberts, L, Scott, C, Sarafidis, P & FIDELIO-DKD and FIGARO-DKD Investigators 2025, ' Efficacy and safety of finerenone in patients with an acute change in estimated glomerular filtration rate in the prespecified FIDELITY pool analysis ', Kidney International, vol. 108, no. 1, pp. 136-144 . https://doi.org/10.1016/j.kint.2025.03.018
Publisher Information: Elsevier BV, 2025.
Publication Year: 2025
Subject Terms: kidney outcomes, nonsteroidal mineralocorticoid receptor antagonist, acute eGFR decline, finerenone, cardiovascular outcomes
Description: IntroductionThe efficacy and safety of finerenone (a nonsteroidal mineralocorticoid receptor antagonist) versus placebo were assessed according to different changes in estimated glomerular filtration rate (eGFR) using data from FIDELITY, a pooled individual-level analysis of two clinical trials.MethodsPatients had chronic kidney disease (eGFR of 25 ml/min/1.73 m2 or greater) and type 2 diabetes with optimized renin-angiotensin system blockade. Risk of composite cardiovascular and composite kidney outcomes was analyzed by baseline eGFR change at month one in the total population and by treatment group.ResultsOf 12,798 patients, 25.1% had a >10% eGFR decline, 31.2% had a >0–10% decline, 26.8% had a 0–10% increase, and 16.8% had a >10% increase after one month of treatment. Factors associated with acute eGFR decline included higher baseline urine albumin-to-creatinine ratio, eGFR, systolic blood pressure, diuretic or beta-blocker use, and finerenone use. Finerenone significantly reduced composite cardiovascular and kidney outcomes overall and had similar beneficial effect across eGFR subgroups of >10% decline, >0–10% decline, 0–10% increase, and >10% increase for composite cardiovascular (hazard ratio [95% Confidence Interval] of 0.74 [0.61–0.90], 0.87 [0.73–1.04], 1.06 [0.87–1.28], and 0.78 [0.61–0.99], respectively) and kidney outcomes (0.67 [0.53–0.85], 0.78 [0.61–1.01], 0.56 [0.40–0.77], and 0.75 [0.50–1.14], respectively) (P interaction 0.048 and 0.23, respectively). When modeled as a continuous variable, finerenone reduced the risk of cardiovascular and kidney outcomes, irrespective of acute eGFR change (P interaction 0.58 and 0.36, respectively).ConclusionsThe cardiovascular and kidney benefits of finerenone were not modified by an acute eGFR change after drug initiation. Introduction: The efficacy and safety of finerenone (a nonsteroidal mineralocorticoid receptor antagonist) versus placebo were assessed according to different changes in estimated glomerular filtration rate (eGFR) using data from FIDELITY, a pooled individual-level analysis of two clinical trials. Methods: Patients had chronic kidney disease (eGFR of 25 ml/min/1.73 m2 or greater) and type 2 diabetes with optimized renin-angiotensin system blockade. Risk of composite cardiovascular and composite kidney outcomes was analyzed by baseline eGFR change at month one in the total population and by treatment group. Results: Of 12,798 patients, 25.1% had a >10% eGFR decline, 31.2% had a >0–10% decline, 26.8% had a 0–10% increase, and 16.8% had a >10% increase after one month of treatment. Factors associated with acute eGFR decline included higher baseline urine albumin-to-creatinine ratio, eGFR, systolic blood pressure, diuretic or beta-blocker use, and finerenone use. Finerenone significantly reduced composite cardiovascular and kidney outcomes overall and had similar beneficial effect across eGFR subgroups of >10% decline, >0–10% decline, 0–10% increase, and >10% increase for composite cardiovascular (hazard ratio [95% Confidence Interval] of 0.74 [0.61–0.90], 0.87 [0.73–1.04], 1.06 [0.87–1.28], and 0.78 [0.61–0.99], respectively) and kidney outcomes (0.67 [0.53–0.85], 0.78 [0.61–1.01], 0.56 [0.40–0.77], and 0.75 [0.50–1.14], respectively) (P interaction 0.048 and 0.23, respectively). When modeled as a continuous variable, finerenone reduced the risk of cardiovascular and kidney outcomes, irrespective of acute eGFR change (P interaction 0.58 and 0.36, respectively). Conclusions: The cardiovascular and kidney benefits of finerenone were not modified by an acute eGFR change after drug initiation.
Document Type: Article
File Description: application/pdf
Language: English
ISSN: 0085-2538
DOI: 10.1016/j.kint.2025.03.018
Access URL: https://curis.ku.dk/ws/files/511225612/1-s2.0-S0085253825003230-main.pdf
Rights: CC BY
Accession Number: edsair.doi.dedup.....1b4ed185ca66fdf75b55a688e01c862a
Database: OpenAIRE
Description
Abstract:IntroductionThe efficacy and safety of finerenone (a nonsteroidal mineralocorticoid receptor antagonist) versus placebo were assessed according to different changes in estimated glomerular filtration rate (eGFR) using data from FIDELITY, a pooled individual-level analysis of two clinical trials.MethodsPatients had chronic kidney disease (eGFR of 25 ml/min/1.73 m2 or greater) and type 2 diabetes with optimized renin-angiotensin system blockade. Risk of composite cardiovascular and composite kidney outcomes was analyzed by baseline eGFR change at month one in the total population and by treatment group.ResultsOf 12,798 patients, 25.1% had a >10% eGFR decline, 31.2% had a >0–10% decline, 26.8% had a 0–10% increase, and 16.8% had a >10% increase after one month of treatment. Factors associated with acute eGFR decline included higher baseline urine albumin-to-creatinine ratio, eGFR, systolic blood pressure, diuretic or beta-blocker use, and finerenone use. Finerenone significantly reduced composite cardiovascular and kidney outcomes overall and had similar beneficial effect across eGFR subgroups of >10% decline, >0–10% decline, 0–10% increase, and >10% increase for composite cardiovascular (hazard ratio [95% Confidence Interval] of 0.74 [0.61–0.90], 0.87 [0.73–1.04], 1.06 [0.87–1.28], and 0.78 [0.61–0.99], respectively) and kidney outcomes (0.67 [0.53–0.85], 0.78 [0.61–1.01], 0.56 [0.40–0.77], and 0.75 [0.50–1.14], respectively) (P interaction 0.048 and 0.23, respectively). When modeled as a continuous variable, finerenone reduced the risk of cardiovascular and kidney outcomes, irrespective of acute eGFR change (P interaction 0.58 and 0.36, respectively).ConclusionsThe cardiovascular and kidney benefits of finerenone were not modified by an acute eGFR change after drug initiation. Introduction: The efficacy and safety of finerenone (a nonsteroidal mineralocorticoid receptor antagonist) versus placebo were assessed according to different changes in estimated glomerular filtration rate (eGFR) using data from FIDELITY, a pooled individual-level analysis of two clinical trials. Methods: Patients had chronic kidney disease (eGFR of 25 ml/min/1.73 m2 or greater) and type 2 diabetes with optimized renin-angiotensin system blockade. Risk of composite cardiovascular and composite kidney outcomes was analyzed by baseline eGFR change at month one in the total population and by treatment group. Results: Of 12,798 patients, 25.1% had a >10% eGFR decline, 31.2% had a >0–10% decline, 26.8% had a 0–10% increase, and 16.8% had a >10% increase after one month of treatment. Factors associated with acute eGFR decline included higher baseline urine albumin-to-creatinine ratio, eGFR, systolic blood pressure, diuretic or beta-blocker use, and finerenone use. Finerenone significantly reduced composite cardiovascular and kidney outcomes overall and had similar beneficial effect across eGFR subgroups of >10% decline, >0–10% decline, 0–10% increase, and >10% increase for composite cardiovascular (hazard ratio [95% Confidence Interval] of 0.74 [0.61–0.90], 0.87 [0.73–1.04], 1.06 [0.87–1.28], and 0.78 [0.61–0.99], respectively) and kidney outcomes (0.67 [0.53–0.85], 0.78 [0.61–1.01], 0.56 [0.40–0.77], and 0.75 [0.50–1.14], respectively) (P interaction 0.048 and 0.23, respectively). When modeled as a continuous variable, finerenone reduced the risk of cardiovascular and kidney outcomes, irrespective of acute eGFR change (P interaction 0.58 and 0.36, respectively). Conclusions: The cardiovascular and kidney benefits of finerenone were not modified by an acute eGFR change after drug initiation.
ISSN:00852538
DOI:10.1016/j.kint.2025.03.018