DOSING, TREATMENT PATTERNS, UACR CHANGES, AND SAFETY WITH FINERENONE TREATMENT: AN INTERIM ANALYSIS OF THE ASIA-PACIFIC COHORT OF FINE-REAL

 

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DOSING, TREATMENT PATTERNS, UACR CHANGES, AND SAFETY WITH FINERENONE TREATMENT: AN INTERIM ANALYSIS OF THE ASIA-PACIFIC COHORT OF FINE-REAL

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Nan Hee
Kim
Nan Hee Kim nhkendo@gmail.com Korea University College of Medicine Division of Endocrinology and Metabolism, Department of Internal Medicine Seoul Korea (Republic of) *
Lixin Guo glx1218@163.com Chinese Academy of Medical Sciences Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine Beijing China -
Kevin M. Pantalone PANTALK@ccf.org Cleveland Clinic . Cleveland, OH United States -
Christoph Wanner Wanner_C@ukw.de University Hospital Würzburg . Würzburg Germany -
David C. Wheeler d.wheeler@ucl.ac.uk University College London . London United Kingdom -
Nihar R. Desai nihar.desai@yale.edu Yale School of Medicine . New Haven, CT United States -
Ricardo Correa-Rotter correarotter@gmail.com Instituto Nacional de Ciencias Médicas y Nutricion Salvador Zubiran . Ciudad de Mexico Mexico -
Susanne B. Nicholas sunicholas@mednet.ucla.edu David Geffen School of Medicine University of California Los Angeles, CA United States -
Sonia Ares Gómez sonia.gomez.ext@bayer.com Syneos Health . Madrid Spain -
Andrea Horvat-Broecker andrea.horvat-broecker@bayer.com Bayer AG . Wuppertal Germany -
Marcel Schulze marcel.schulze1@bayer.com Bayer AG . Berlin Germany -
Martin Merz martin.merz@bayer.com Bayer AG . Berlin Germany -
Sankar D. Navaneethan Sankar.Navaneethan@bcm.edu Baylor College of Medicine . Houston, TX United States -
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FINE-REAL (NCT05348733) assesses real-world finerenone use in participants (pts) ≥18 years with type 2 diabetes mellitus (T2D) and chronic kidney disease (CKD). This interim analysis describes dosing strategies, treatment patterns, UACR changes, and safety during treatment with finerenone in the FINE-REAL Asia-Pacific (APAC) cohort.  

FINE-REAL is a global, prospective, single-arm, non-interventional study conducted in 19 countries. The APAC region included China mainland (n=297), South Korea (n=716), Singapore (n=21), Taiwan (n=177), and Thailand (n=75). Pts were recruited mainly from nephrology (51%) and endocrinology (47%) settings and enrolled only after the decision to initiate finerenone. Data were collected between June 13, 2022 and June 13, 2025 (data cut-off). Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that occurred during finerenone therapy regardless of any potential relationship to treatment. 

Of 1286 APAC pts, 897 (70%) were male; mean (SD) age was 65 (12) years. Mean (SD) duration of T2D and CKD was 15.8 (9.5) years (n=1148) and 4.8 (5.1) years (n=1111), respectively. Median (IQR) follow-up was 119.5 (1−337) days. At baseline, mean (SD) eGFR was 55 (21) mL/min/1.73 m2 (n=1255) and median (IQR) UACR was 515 (198−1292) mg/g (n=943), versus mean (SD) eGFR 55 (20) mL/min/1.73 m2 and median (IQR) UACR 629 (262−1354) in the FIDELITY Asian population (n=2858).[1] Mean (SD) HbA1c was 7.5 (1.5) % (n=1014). Concomitant RAASi, SGLT2i, and GLP-1 RA were used by 1064 (83%), 784 (61%), and 185 (14%) pts, respectively. Finerenone was initiated at 10 mg in 984 (77%) and 20 mg in 302 (23%) pts, respectively; 18% of pts initiated on 10 mg were up-titrated at least once and 8% of pts initiated on 20 mg were down-titrated at least once. UACR data for pts with values at baseline and follow-up are shown in the table. UACR declined between baseline and 4 months and 12 months, with reductions from baseline in median UACR of 41% and 42%, respectively, exceeding the ADA recommendation of >30% reduction.[2] TEAEs and treatment-emergent serious AEs were observed in 379 (29%) and 110 (9%) pts, respectively. Treatment-emergent hyperkalemia events were reported in 104 (8%) pts, leading to permanent discontinuation in 5 (0.4%); serious treatment-emergent hyperkalemia events were reported in 2 (0.2%) pts, leading to hospitalization in 1 (<0.1%); no hyperkalemia events were life-threatening or led to dialysis or death.  

Table

Despite use of other guideline-directed therapies in many pts, finerenone reduced UACR between baseline and 4 months; this effect was maintained at 12 months. Kidney impairment at baseline in the APAC cohort of FINE-REAL was less severe compared with the FIDELITY Asian population.[1] A greater proportion of FINE-REAL pts received concomitant SGLT2i or GLP-1 RA than in the FIDELITY Asian population or recent registries; RAASi use was greater in the FIDELITY Asian population.[1,3−5] Safety was favorable and consistent with the known safety profile of finerenone.

References

1. Wada T, et al. Kidney Dis 2025;11:402−15.

2. ADA Professional Practice Committee. Diabetes Care 2025;48:S239−51.

3. Nicholas SB, et al. Diabetes Obes Metab 2023;25:2970−9.

4. Lim C-E, et al. Eur J Prev Cardiol 2023;30:634−43.

5. Jeong SJ, et al. BMC Nephrol 2021;22:177.

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