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Abstract: SA-PO273

Effect of Finerenone on CKD Outcomes in Type 2 Diabetes: A Chinese Subgroup Analysis of the FIDELIO-DKD Study

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Zhang, Haitao, National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China
  • Xie, Jingyuan, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
  • Hao, Chuanming, Huashan Hospital Fudan University, Shanghai, Shanghai, China
  • Li, Xuemei, Peking Union Medical College Hospital, Dongcheng-qu, Beijing, China
  • Zhu, Dalong, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China
  • Zheng, Hongguang, General Hospital of Northern Theater Command, Shenyang, China
  • Xu, Xudong, Fudan University Minhang Hospital, Shanghai, China
  • Mo, Zhaohui, The Third Xiangya Hospital of Central South University, Changsha, China
  • Lu, Weiping, The Affiliated Huaian No.1 People’s Hospital of Nanjing Medical University, Huaian, China
  • Lu, Yibing, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China
  • Wu, Chaoqing, The People’s Hospital of Guangxi Zhuang Autonomous Regio, Guangxi, China
  • Tong, Nanwei, Sichuan University West China Hospital, Chengdu, Sichuan, China
  • Wang, Li, Bayer Healthcare Company, Beijing, China
  • Liu, Zhihong, National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China
Background

This subgroup analysis of FIDELIO-DKD trial aimed to evaluate the efficacy and safety of finerenone in chronic kidney disease (CKD) patients with type 2 diabetes mellitus (T2DM) in China.

Methods

Three hundred and seventy-two participants who were recruited from 67 centers in China were randomized 1:1 to oral finerenone or placebo with standard therapy for diabetes. The primary outcome was a composite of kidney failure, sustained decrease of estimated glomerular filtration rate (eGFR) >40% from baseline over at least 4 weeks, or renal death. The key secondary composite outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure.

Results

After a median follow-up of 30 months, the finerenone group showed a relative risk reduction (RRR) of 41% (hazard ratio [HR]=0.59, 95% confidence interval [CI], 0.39 to 0.88; p=0.009) for the primary composite outcome compared to the placebo group, and was consistent across its components with treatment benefit in finerenone group. For the key secondary composite outcome, the finerenone group showed a RRR of 25% (HR=0.75, 95% CI, 0.38 to 1.48; p=0.408), while the global results showed significant differences in favor of finerenone with a RRR of 14% (HR=0.86, 95% CI, 0.75 to 0.99; p=0.03). Adverse events were similar between the two groups. Hyperkalemia leading to discontinuation occurred in 8 (4.3%) and 2 (1.1%) participants in the finerenone and control groups, respectively.

Conclusion

Finerenone resulted in lower risks of CKD progression than placebo and a balanced safety profile in Chinese CKD patients with T2DM.

Funding

  • Commercial Support