Kidney Week

Abstract: PUB111

Characteristics, Clinical Outcomes, and Safety of New Users of Finerenone with CKD and Type 2 Diabetes in Routine Clinical Practice in Japan: A FOUNTAIN Platform Analysis

Session Information

• Publication Only

Category: Diabetic Kidney Disease

• 702 Diabetic Kidney Disease: Clinical

Authors

• Kanasaki, Keizo, Department of Internal Medicine 1, Faculty of Medicine, Shimane University, Izumo, Japan

Keizo Kanasaki, MD, PhD

• Rodriguez Molina, Daloha, Bayer AG, Leverkusen, Nordrhein-Westfalen, Germany

Daloha Rodriguez Molina, MD, PhD

• Yoshikawa-Ryan, Kanae, Bayer Yakuhin Ltd., Medical Affairs & Pharmacovigilance, Osaka, Japan

Kanae Yoshikawa-Ryan, MD

• Yamashita, Satoshi, Bayer Yakuhin Ltd., Medical Affairs & Pharmacovigilance, Osaka, Japan

Satoshi Yamashita, MS

• Okami, Suguru, Bayer Yakuhin Ltd., Medical Affairs & Pharmacovigilance, Osaka, Japan

Suguru Okami, PhD, RPh

• Liu, Fangfang, Bayer AG, Leverkusen, Nordrhein-Westfalen, Germany

Fangfang Liu, PhD

• Farjat, Alfredo E., Bayer AG, Leverkusen, Nordrhein-Westfalen, Germany

Alfredo E. Farjat, PhD

• Oberprieler, Nikolaus G., Bayer AG, Leverkusen, Nordrhein-Westfalen, Germany

Nikolaus G. Oberprieler, PhD

• Kovesdy, Csaba P., University of Tennessee, Memphis, Tennessee, United States

Csaba P. Kovesdy, MD, FASN

• Sato, Atsuhisa, Department of Internal Medicine, Division of Nephrology and Hypertension, International University of Health and Welfare School of Medicine, Minatoku, Japan

Atsuhisa Sato, MD, PharmD

• Vizcaya, David, Bayer AG, Leverkusen, Nordrhein-Westfalen, Germany

David Vizcaya, PhD, MPH

Background

In clinical trials, finerenone reduced risks of cardiovascular and renal complications among patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Evidence regarding finerenone use in real-world clinical settings is limited. This study aims to describe clinical characteristics, outcomes, and safety of new users of finerenone in Japan.

Methods

A retrospective observational cohort study using electronic health records and claims data from Japanese hospital-based databases provided by Real-World Data, Co. was conducted. Persons initiating finerenone from July 2021 to August 2023 with prior CKD and T2D were included. Prevalence of comorbidities and use of concomitant medication during the previous 365 and 180 days were calculated. Occurrence of kidney failure, a composite cardiovascular outcome, and hyperkalemia was assessed during follow-up.

Results

A total of 92 new users of finerenone were identified during the study period. Patient characteristics are described in Table 1. Median follow-up was 49 days. We observed no case of kidney failure and only one of a composite cardiovascular outcome. No patients showed serum potassium >5.5mmom/l or fatal hyperkalemia/hospitalization associated with hyperkalemia during follow-up. Results from ongoing analysis of several hundred finerenone users in one additional database will be presented at the conference presentation.

Conclusion

Early evidence from clinical practice in Japan suggests that finerenone is used for patients across risk stages and comedications. This study is the first database study conducted on evaluation of finerenone use in Japan.

Funding

• Commercial Support – Bayer