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Cited by 109Chronic Kidney Disease and DiabetesHormonal Regulation and HypertensionAcute Kidney Injury Research

Impact of Finerenone-Induced Albuminuria Reduction on Chronic Kidney Disease Outcomes in Type 2 Diabetes: A Mediation Analysis

Agarwal, Rajiv, Tu, Wanzhu, Farjat, Alfredo E., Farag, Youssef M.K., Toto, Robert, Kaul, Sanjay, Lawatscheck, Robert, Rohwedder, Katja +1539 more·2023·Annals of Internal Medicine
DOI 10.7326/m23-1023
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Abstract

Background In patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), finerenone, a nonsteroidal mineralocorticoid receptor antagonist, reduces cardiovascular and kidney failure outcomes. Finerenone also lowers the urine albumin-to-creatinine ratio (UACR). Whether finerenone-induced change in UACR mediates cardiovascular and kidney failure outcomes is unknown. Objective To quantify the proportion of kidney and cardiovascular risk reductions seen over a 4-year period mediated by a change in kidney injury, as measured by the change in log UACR between baseline and month 4. Design Post hoc mediation analysis using pooled data from 2 phase 3, double-blind trials of finerenone. (ClinicalTrials.gov: NCT02540993 and NCT02545049). Setting Several clinical sites in 48 countries. Patients 12 512 patients with CKD and T2D. Intervention Finerenone and placebo (1:1). Measurements Separate mediation analyses were done for the composite kidney (kidney failure, sustained ≥57% decrease in estimated glomerular filtration rate from baseline [approximately a doubling of serum creatinine], or kidney disease death) and cardiovascular (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) outcomes. Results At baseline, median UACR was 514 mg/g. A 30% or greater reduction in UACR was seen in 3338 (53.2%) patients in the finerenone group and 1684 (27.0%) patients in the placebo group. Reduction in UACR (analyzed as a continuous vari…

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Crossref · 10.7326/m23-1023

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  • Both SGLT2 inhibitors and finerenone have shown that the majority of their beneficial effect is mediated by reduction in albuminuria.

    “Reduction in albuminuria is also important to evaluate the efficacy of medications prescribed for kidney protection, as both SGLT2 inhibitors and finerenone have shown that the majority of their beneficial effect is mediated by reduction in albuminuria (42,43).”

    From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [42]

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Agarwal, R., Tu, W., Farjat, A. E., Farag, Y. M. K., Toto, R., Kaul, S., Lawatscheck, R., Rohwedder, K., Ruilope, L. M., Rossing, P., Pitt, B., Filippatos, G., Anker, S. D., Bakris, G. L., FIDELIO-DKD and FIGARO-DKD Investigators, Vallejos, A., MacIsaac, R., Schernthaner, G., Gillard, P., Canziani, M. E. F., Temelkova-Kurktschiev, T., Burgess, E., Tobe, S., González, F., Liu, Z.-H., Bonfanti, A. Á. C., Jaramillo, C. F., Prazny, M., Strand, J., Marre, M., Schmieder, R., Wanner, C., Sarafidis, P. A., Chan, J., Rosivall, L., Eustace, J., Grossman, E., Yagil, Y., Remuzzi, G., Koya, D., Wada, T., Rovalo, M. M., Gansevoort, R., Kooy, A., Finnes, T., DeLeon, F., Gumprecht, J., Teixeira e Costa, F., Dreval, A., Vathsala, A., Amod, A., Kim, S. G., Lee, B. W., Santos, J. P., Tengmark, B.-O., Burnier, M., Lee, C.-T., Yamwong, S., Sari, R., McCafferty, K., Mankovsky, B., Adler, S., Fried, L., Williams, M., Khanh, T. 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Affiliations
  • Richard L. Roudebush VA Medical Center (US)
  • Indiana University Indianapolis (US)
  • Bayer (United Kingdom) (GB)
  • Bayer U.S. LLC, Cambridge, Massachusetts (Y.M.K.F.)
  • The University of Texas Southwestern Medical Center (US)
  • Cedars-Sinai Medical Center (US)
  • Bayer (Germany) (DE)
  • Research Institute Hospital 12 de Octubre (ES)
  • University of Copenhagen (DK)
  • University of Michigan (US)
  • National and Kapodistrian University of Athens (GR)
  • Wroclaw Medical University (PL)
  • University of Chicago (US)
ORCID
Venue
Annals of Internal Medicine
Publisher
American College of Physicians
Published
2023-12
Volume
176
Issue
12
Pages
1606-1616
ISSN
  • 0003-4819 (ISSN-L)
  • 1539-3704
DOI
10.7326/m23-1023
OpenAlex
W4389296163
Cited by
109
References
37
Citations by year
2026: 44 · 2025: 42 · 2024: 21 · 2023: 2
FWCI
21.15
Type
journal article
Language
en
Open access
closed
Locations
  • Annals of Internal Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Research at the University of Copenhagen (University of Copenhagen) (publishedVersion)
  • University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion)
Funders
Bayer
Topics
  • Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal Regulation and Hypertension
  • Health Sciences › Medicine › Nephrology › Acute Kidney Injury Research
Keywords
albuminuria, chronic kidney disease, type 2 diabetes, non-steroidal mineralocorticoid receptor antagonists, albumin-creatinine ratio, mediation analysis, renal failure, cardiovascular outcomes, estimated glomerular filtration rate decline, heart failure hospitalization
MeSH terms
Mediation Analysis, Albuminuria, Diabetes Mellitus, Type 2, Diabetic Nephropathies, Glomerular Filtration Rate, Humans, Naphthyridines, Renal Insufficiency, Chronic, Renal Insufficiency

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