Abstract
Purpose
Renal anemia is a common complication of chronic kidney disease. Currently, recombinant human erythropoietin and roxadustat are the main treatments. In China, diabetic kidney disease is the primary cause of chronic kidney disease. However, high-quality evidence on the efficacy of roxadustat in patients with non-dialysis-dependent chronic kidney disease and diabetes mellitus is scarce. This study aimed to assess the clinical effect of roxadustat in such patients.
Methods
Patients with non-dialysis-dependent anemia and diabetes mellitus who received roxadustat or recombinant human erythropoietin for ≥ 4 weeks were enrolled. We compared baseline characteristics, including age, gender, hypertension, and hemoglobin level, and then employed a 1:3 ratio propensity score matching. The primary efficacy outcomes were changes in hemoglobin levels. After propensity score matching, 212 patients were analyzed, including the roxadustat (n = 53) and recombinant human erythropoietin (n = 159) groups. Baseline characteristics were comparable, including hemoglobin level, estimated glomerular filtration rate, and glycated hemoglobin A1c (p > 0.05).
Results
After 4, 12, and 24 weeks of treatment, the median hemoglobin levels in the roxadustat group were 97.5 g/L, 104 g/L, and 106.5 g/L, respectively, significantly surpassing the corresponding levels in the recombinant human erythropoietin group at 91 g/L, 94.5 g/L, and 94.5 g/L (p = 0.002, p = 0.025, p = 0.006, respectively). Additionally, subgroup analysis demonstrated better treatment efficacy of roxadustat patients with elevated high-sensitivity C-reactive protein and low albumin levels.
Conclusion
In Chinese patients with anemia and diabetes not on dialysis, roxadustat efficiently and rapidly improved and maintained hemoglobin levels unaffected by elevated high-sensitivity C-reactive protein and low albumin levels.
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Availability of data and materials
The dataset generated and/or analyzed during the current study is not publicly available due to restrictions of patient privacy or ethical. But they are available upon reasonable request to the corresponding author.
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Acknowledgements
We would highly appreciate the excellent contributions from our colleagues at Zhejiang Provincial People’s Hospital to this study. We also sincerely thanks for the Yidu Cloud Technology Company Ltd due to their technical support and data platform.
Funding
This work was supported by the National Natural Science Foundation of China under Grant [number 82202042]; Medical Science and Technology Project of Zhejiang Province under Grant [number 2023KY454]; the Zhejiang Traditional Chinese Medicine Science and Technology Program [2023ZL261].
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Q He, L Shao: project design and development. Y Li, B Zhu: administrative support. X Hu, Y Shang, M Wang: collection, management, and assembly of data. C Jin, Y Ren: data collection, management, analysis, manuscript writing and editing.
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This study was approved by the Ethics Committee of Zhejiang Provincial People’s Hospital (2022QT346) and conducted under the Declaration of Helsinki, 2013 revision. We protected patients privacy by anonymizing all data. The retrospective study waived informed consent requirements.
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Jin, C., Ren, Y., Wang, M. et al. Clinical effect of roxadustat vs. erythropoietin in non-dialysis CKD with diabetes: a single center propensity score matching analysis. Int Urol Nephrol (2024). https://doi.org/10.1007/s11255-024-03983-0
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DOI: https://doi.org/10.1007/s11255-024-03983-0