Finerenone in Japanese Patients with Diabetic Kidney Disease: Insights from the J-DREAMS Real-World Database

 

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https://storage.unitedwebnetwork.com/files/1099/ee9bf57d8ff91cfc40f7b0e82b234c08.pdf
Finerenone in Japanese Patients with Diabetic Kidney Disease: Insights from the J-DREAMS Real-World Database

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Mitsuru
Ohsugi
Mitsuru Ohsugi ohsugi.m@jihs.go.jp Japan Institute for Health Security Diabetes and Metabolism Information Center Tokyo Japan *
Ryotaro Bouchi bouchi.r@jihs.go.jp Japan Institute for Health Security Diabetes and Metabolism Information Center Tokyo Japan -
Kanae Yoshikawa-Ryan kanae.ryan@bayer.com Bayer Yakuhin Integrated Evidence Generation Tokyo Japan -
Satoshi Yamashita satoshi.yamashita@bayer.com Bayer Yakuhin General Medicine Medical Affairs Tokyo Japan -
Suguru Okami suguru.okami@bayer.com Bayer Yakuhin Integrated Evidence Generation Tokyo Japan -
Kohjiro Ueki ueki.k@jihs.go.jp Japan Institute for Health Security Diabetes Research Center Tokyo Japan -
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Diabetic kidney disease (DKD) remains a leading cause of end-stage renal disease worldwide. Finerenone, a non-steroidal mineralocorticoid receptor antagonist, has demonstrated renal and cardiovascular benefits in randomized controlled trials. However, real-world evidence in Asian populations, particularly in Japan, is limited. This study aims to evaluate the renal effects of finerenone in Japanese patients with DKD using the J-DREAMS database, a nationwide real-world registry.

We conducted a retrospective cohort analysis of patients with type 2 diabetes mellitus (T2DM) and DKD who initiated finerenone therapy, identified from the J-DREAMS database between June 1, 2021, and March 31, 2025. Patients undergoing dialysis or kidney transplantation were excluded. Renal function was assessed using estimated glomerular filtration rate (eGFR), and albuminuria was evaluated via urinary albumin-to-creatinine ratio (UACR). Changes in eGFR slope and UACR were analyzed over a 12-month period, stratified by CKD stages (G1–G4 and G2–G4 subsets). Statistical comparisons were performed using linear mixed models, and 95% confidence intervals (CI) were calculated for UACR changes.

Among 24,868 patients with T2DM, 482 individuals initiated finerenone therapy. Their baseline characteristics were as follows: mean age 67.7 ± 12.5 years, 29.3% female, diabetes duration 18.9 ± 11.7 years, HbA1c 7.2 ± 1.1%, eGFR 51.7 ± 24.2 ml/min/1.73m², and UACR 810 ± 1485 mg/g creatinine. 32 (6.6%), 107 (22.2%), 258 (53.5%), and 78 (16.2%) patients were classified as CKD stages G1, G2, G3, and G4, respectively. Compared to the overall T2DM cohort, finerenone initiators were older, predominantly male, had a longer duration of diabetes, lower eGFR, and higher UACR.

eGFR slope:

From 12 months prior to baseline:

G1–G4: −2.19 ml/min/1.73m²/year

G2–G4: −2.57 ml/min/1.73m²/year

From baseline to 12 months post-finerenone:

G1–G4: −3.13 ml/min/1.73m²/year

G2–G4: −1.35 ml/min/1.73m²/year

UACR reduction:

G1–G4:

0 to 4 months: −0.151 (95% CI: −0.219 to −0.082)

0 to 9 months: −0.276 (95% CI: −0.340 to −0.213)

0 to 12 months: −0.244 (95% CI: −0.315 to −0.173)

G2–G4:

0 to 4 months: −0.132 (95% CI: −0.205 to −0.060)

0 to 9 months: −0.238 (95% CI: −0.307 to −0.169)

0 to 12 months: −0.233 (95% CI: −0.310 to −0.156)

These findings suggest a stabilization or attenuation of renal function decline in G2–G4 patients following finerenone initiation, with consistent reductions in albuminuria across subgroups.

This real-world analysis from the J-DREAMS database supports the renal protective effects of finerenone in Japanese patients with DKD, particularly in those with moderate-to-advanced CKD stages. The observed improvements in UACR and eGFR slope warrant further investigation in a full cohort analysis and may inform clinical decision-making in Asian populations.

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