Finerenone in Patients with Chronic Kidney Disease and Type 2 Diabetes: The FIDELIO-DKD Subgroup from China

Abstract

Background: This prespecified subgroup analysis of the FIDELIO-DKD trial aimed to evaluate the efficacy and safety of finerenone in patients with chronic kidney disease (CKD) and type 2 diabetes mellitus (T2DM) in China. Methods: Three hundred and seventy-two participants were recruited from 67 centers in China and randomized 1:1 to oral finerenone or placebo with standard therapy for T2DM. The primary composite outcome included 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 included 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 with placebo, consistent across its components with treatment benefits with finerenone. Based on an absolute between-group difference of 12.2% after 30 months, the number of patients who needed to be treated (NNT) with finerenone to prevent one primary outcome event was eight (95%CI: 4 to 84). 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). Adverse events were similar between the two groups. The effects of finerenone on blood pressure were modest. No gynecomastia events were reported in the study. Hyperkalemia leading to discontinuation occurred in eight (4.3%) and two (1.1%) participants in the finerenone and control groups, respectively. The incidence of acute kidney injury was comparable between the two groups (1.6% vs. 1.6%). Conclusions: Finerenone resulted in lower risks of CKD progression than placebo and a balanced safety profile in Chinese patients with CKD and T2DM.

Guideline for the Management of Diabetes Mellitus in the Elderly in China (2024 Edition)

“…The FIDELIO‐DKD study has demonstrated a significant decrease in the risk of renal composite endpoint events in patients with T2DM and CKD treated with finerenone 166 . The results from the Chinese subgroup data are consistent with those in the overall population 167 . The FIDELITY study, a predefined pooled analysis of two large international multicenter phase III trials (FIDELIO‐DKD and FIGARO‐DKD 168 ), has revealed that finerenone significantly decreases the long‐term risk of renal and cardiac composite events in older individuals with T2DM and CKD, in agreement with findings in the overall population 169 .…”

“… 166 The results from the Chinese subgroup data are consistent with those in the overall population. 167 The FIDELITY study, a predefined pooled analysis of two large international multicenter phase III trials (FIDELIO‐DKD and FIGARO‐DKD 168 ), has revealed that finerenone significantly decreases the long‐term risk of renal and cardiac composite events in older individuals with T2DM and CKD, in agreement with findings in the overall population. 169 For older patients with diabetes with CKD and proteinuria (eGFR ≥25 mL min −1 (1.73 m 2 ) −1 ), adding finerenone to the maximum tolerated dose of ACEI or ARB is recommended to decrease proteinuria and delay CKD progression.…”