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      Effect of Roxadustat versus erythropoietin (EPO) for treating anemia in patients with diabetic kidney disease: a retrospective cohort study

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          Abstract

          Background

          Renal anemia of diabetic kidney disease (DKD) shows higher incidence rate, earlier onset and higher severity than other chronic kidney disease (CKD). Roxadustat, an oral hypoxia-inducible factor-prolyl hydroxylase inhibitor, improves CKD anemia. This retrospective cohort study evaluates if Roxadustat could effectively treat DKD anemia.

          Methods

          DKD anemia patients treated with either Roxadustat or erythropoietin (EPO) for 3 months in two hospitals were enrolled. EPO group were matched 1:1 to Roxadustat group based on age, gender and baseline Hb. Baseline data include age, sex, dialysis, height, weight, hemoglobin (Hb), hematocrit (Hct), serum albumin (ALB), serum creatinine (Scr), eGFR, C-reactive protein (CRP), and intact parathyroid hormone (iPTH). Primary and secondary outcomes were change of Hb (ΔHb) and Hct (ΔHct), Hb response rate and Hb qualified rate. Sensitivity analyses were performed and the effect size were calculated.

          Results

          No significant differences were observed in body mass index (BMI), Scr, eGFR, Hct, CRP, and dialysis between the 2 groups (61 subjects each). ALB, iPTH, and DKD stage differed between the 2 groups. After 3-month treatment, Roxadustat significantly increased patients’ Hb and Hct. Although ΔHb and ΔHct of the Roxadustat group was higher than those of EPO group, difference in the least-square mean changes (95% CI) were 4.9 (–2.4, 12.1) and 1.2 (–1.1, 3.4), while Cohen’s d were 0.18 and 0.14, suggesting that Roxadustat’s ability to increase Hb within 3-month was similar to EPO. 78.7% and 54.1% of the patients responded to anti-anemia therapy in the Roxadustat and EPO group, respectively. Logistic regression analysis showed the Hb response rate of Roxadustat was 3.30 (1.20, 9.94) times higher than that of EPO. Subgroup analysis suggested that Roxadustat might have better efficacy in treating patients in the advanced stage, with high CRP and iPTH, and low ALB levels.

          Conclusions

          In DKD patients, Roxadustat improves renal anemia. Effect of Roxadustat is similar to that of EPO.

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          Most cited references39

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          Roxadustat Treatment for Anemia in Patients Undergoing Long-Term Dialysis

          Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and regulates iron metabolism. Additional data are needed regarding the effectiveness and safety of roxadustat as compared with standard therapy (epoetin alfa) for the treatment of anemia in patients undergoing dialysis.
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            Roxadustat for Anemia in Patients with Kidney Disease Not Receiving Dialysis

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              Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor Roxadustat (FG-4592) for the Treatment of Anemia in Patients with CKD.

              Roxadustat (FG-4592), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis, regulates iron metabolism, and reduces hepcidin, was evaluated in this phase 2b study for safety, efficacy, optimal dose, and dose frequency in patients with nondialysis CKD.
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                Author and article information

                Journal
                Ann Transl Med
                Ann Transl Med
                ATM
                Annals of Translational Medicine
                AME Publishing Company
                2305-5839
                2305-5847
                November 2022
                November 2022
                : 10
                : 22
                : 1224
                Affiliations
                [1 ]deptDepartment of Nephrology, Hunan Key Laboratory of Kidney Disease and Blood Purification, The Second Xiangya Hospital , Central South University , Changsha, China;
                [2 ]deptDepartment of Nephrology, The First Affiliated Hospital of Zhejiang University , Zhejiang University , Hangzhou, China
                Author notes

                Contributions: (I) Conception and design: L Xiao, Y Liu; (II) Administrative support: L Xiao; (III) Provision of study materials or patients: L Xiao, L Sun, Y Liu, F Liu; (IV) Collection and assembly of data: Y Liu, L Zhang, Y Huang, S Zhang; (V) Data analysis and interpretation: Y Liu, L Zhang, Y Huang, Y Zhao, C Wei, K Yang, X Li; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

                [#]

                These authors contributed equally to this work.

                Correspondence to: Li Xiao, MD, PhD. Department of Nephrology, The Second Xiangya Hospital, Central South University, 139 Renmin Middle Road, Changsha 410011, China. Email: xiaolizndx@ 123456csu.edu.cn .
                Article
                atm-10-22-1224
                10.21037/atm-22-4344
                9761136
                36544686
                aa00b752-17e0-4998-ac01-5e18ebd9ae9a
                2022 Annals of Translational Medicine. All rights reserved.

                Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0.

                History
                : 16 August 2022
                : 17 November 2022
                Categories
                Original Article

                roxadustat,renal anemia,diabetic kidney disease (dkd)

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