Objective <p>Given the limited real-world evidence on finerenone in patients with diabetic kidney disease (DKD), particularly with preserved renal function, this study aimed to evaluate the effectiveness and safety of finerenone in DKD patients.</p> Methods <p>We retrospectively analyzed 127 patients with DKD treated with finerenone, including those with preserved renal function. Changes from baseline in the urine albumin-to-creatinine ratio (UACR), urinary microalbumin (mALB), urinary protein semi-quantitative, urinary N-acetyl-β-D-glucosaminidase (NAG) and estimated glomerular filtration rate (eGFR) were evaluated at 1, 3, and 6 months post-treatment. The safety profile was recorded during treatment.</p> Results <p>Following treatment with finerenone, the median UACR was significantly reduced from a baseline of 100&#xa0;mg/g to 59&#xa0;mg/g, 48&#xa0;mg/g, and 43&#xa0;mg/g at 1, 3, and 6 months, respectively (<i>p</i> &lt; 0.001 for 1 and 3 months). Similarly, mALB levels significantly decreased over the same period (<i>p</i> &lt; 0.001). Stratified analysis revealed that the mean UACR reduction at 1, 3, and 6 months was 35%, 33%, and 21% in stage A2 patients, while it was 44%, 58%, and 57% in stage A3 patients (<i>p</i> &lt; 0.0001). Moreover, finerenone significantly improved UACR staging classification, while also reducing both the proportion of proteinuria (<i>p</i> &lt; 0.0001) and urinary NAG levels (<i>p</i> = 0.001). In terms of safety, eGFR exhibited an initial decline followed by a subsequent rise (<i>p</i> = 0.117). Three patients (2.4%) experienced hyperkalemia, and one patient discontinued treatment due to a decrease in eGFR of more than 30%.</p> Conclusion <p>Finerenone demonstrated a significant reduction in proteinuria in DKD patients, particularly in patients with UACR stage A3, with a favorable safety profile.</p>

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Real-world effectiveness and safety of finerenone in diabetic kidney disease with preserved eGFR: a retrospective study in China

  • Yiru Xu,
  • Sha Zeng,
  • Yanhua Xi,
  • Cuiyun Chen,
  • Guilin Zou,
  • Yan Zhang,
  • Jianying Liu

摘要

Objective

Given the limited real-world evidence on finerenone in patients with diabetic kidney disease (DKD), particularly with preserved renal function, this study aimed to evaluate the effectiveness and safety of finerenone in DKD patients.

Methods

We retrospectively analyzed 127 patients with DKD treated with finerenone, including those with preserved renal function. Changes from baseline in the urine albumin-to-creatinine ratio (UACR), urinary microalbumin (mALB), urinary protein semi-quantitative, urinary N-acetyl-β-D-glucosaminidase (NAG) and estimated glomerular filtration rate (eGFR) were evaluated at 1, 3, and 6 months post-treatment. The safety profile was recorded during treatment.

Results

Following treatment with finerenone, the median UACR was significantly reduced from a baseline of 100 mg/g to 59 mg/g, 48 mg/g, and 43 mg/g at 1, 3, and 6 months, respectively (p < 0.001 for 1 and 3 months). Similarly, mALB levels significantly decreased over the same period (p < 0.001). Stratified analysis revealed that the mean UACR reduction at 1, 3, and 6 months was 35%, 33%, and 21% in stage A2 patients, while it was 44%, 58%, and 57% in stage A3 patients (p < 0.0001). Moreover, finerenone significantly improved UACR staging classification, while also reducing both the proportion of proteinuria (p < 0.0001) and urinary NAG levels (p = 0.001). In terms of safety, eGFR exhibited an initial decline followed by a subsequent rise (p = 0.117). Three patients (2.4%) experienced hyperkalemia, and one patient discontinued treatment due to a decrease in eGFR of more than 30%.

Conclusion

Finerenone demonstrated a significant reduction in proteinuria in DKD patients, particularly in patients with UACR stage A3, with a favorable safety profile.