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• W4385993407 abstract "We have read with great interest the article by Heerspink et al.1 Heerspink H.J.L. Jongs N. Neuen B.L. et al. Effects of newer kidney protective agents on kidney endpoints provide implications for future clinical trials. Kidney Int. 2023; 104: 181-188 Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar regarding the effects of newer kidney protective agents on renal endpoints. The authors analyze whether differences were present in the estimated glomerular filtration rate (eGFR) decline thresholds used in the studies that evaluated renal outcomes in the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE), Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD), Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease (FIDELIO-DKD), and the Study of Diabetic Nephropathy with Atrasentan (SONAR) trials. 1 Heerspink H.J.L. Jongs N. Neuen B.L. et al. Effects of newer kidney protective agents on kidney endpoints provide implications for future clinical trials. Kidney Int. 2023; 104: 181-188 Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar The mean eGFR of the patients was between 40 and 45 ml/min per 1.73 m2, with the exception of the CREDENCE trial (eGFR: 56 ml/min per 1.73 m2). Thus, globally, the eGFR was <60 ml/min per 1.73 m2. No significant differences were present in the eGFR decline threshold (57% vs. 40%, 50%), suggesting that incorporating a 40% eGFR decline endpoint would require fewer participants and would facilitate the conduct of clinical trials involving high-risk chronic kidney disease (CKD) patients. However, these impacts would probably not hold for analysis of other studies that have patients with higher mean eGFRs. The Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) study included patients with a mean eGFR of 68 ml/min per 1.73 m2. The renal outcome was a 40% eGFR decline, which was not significant. Nevertheless, when the highest threshold was analyzed (57% eGFR), the results were significant, favoring the intervention arm. 2 Gerstein H.C. Colhoun H.M. Dagenais G.R. et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019; 394: 121-130 Abstract Full Text Full Text PDF PubMed Scopus (1380) Google Scholar In the Dulaglutide and Cardiovascular Outcomes in Type 2 Diabetes (REWIND) study, the mean eGFR was 77 ml/min per 1.73 m2. When renal outcome was evaluated, the criterion was a 30% eGFR decline. With this threshold, the renal outcome was not significant, but when the threshold was analyzed in a prespecified manner, at 40% and 57%, the results were significant and favored the dulaglutide arm. 3 Filippatos G. Anker S.D. Agarwal R. et al. Finerenone reduces risk of incident heart failure in patients with chronic kidney disease and type 2 diabetes: analyses from the FIGARO-DKD trial. Circulation. 2022; 145: 437-447 Crossref PubMed Scopus (0) Google Scholar Effects of newer kidney protective agents on kidney endpoints provide implications for future clinical trialsKidney InternationalVol. 104Issue 1PreviewDoubling of serum creatinine (equivalent to a 57% decline in the estimated glomerular filtration rate (eGFR)) is an accepted component of a composite kidney endpoint in clinical trials. Smaller declines in eGFR (40%, 50%) have been applied in several recently conducted clinical trials. Here, we assessed the effects of newer kidney protective agents on endpoints including smaller proportional declines in eGFR to compare relative event rates and the magnitude of observed treatment effects. We performed a post hoc analysis of 4401 patients in the CREDENCE, 4304 in the DAPA-CKD, 5734 in the FIDELIO-DKD, and 3668 in the SONAR trials, which assessed the effects of canagliflozin, dapagliflozin, finerenone and atrasentan in patients with chronic kidney disease. Full-Text PDF Open AccessThe authors replyKidney InternationalVol. 104Issue 3PreviewWe thank Rico-Fontalvo et al. for their interest in our study.1 The goal of our study was to assess the effect of newer nephroprotective agents on endpoints defined by different estimated glomerular filtration rate (eGFR) decline thresholds (40%, 50%, and 57% eGFR decline) to inform the design of future trials of chronic kidney disease (CKD) progression. We therefore pooled data from 4 trials that recruited patients with CKD who were at high risk of progression, and we demonstrated that the relative effects of newer nephroprotective therapies appear to be generally similar across different eGFR decline thresholds. Full-Text PDF" @default.
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• W4385993407 date "2023-09-01" @default.
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• W4385993407 title "What should be the eGFR decline thresholds on kidney endpoints?" @default.
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• W4385993407 doi "https://doi.org/10.1016/j.kint.2023.06.003" @default.
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