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      Comparison of efficacy of roxadustat and erythropoietin for the treatment of renal anemia in patients with chronic kidney disease: a retrospective study

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          Abstract

          Background

          Renal anemia is a common complication in patients with end-stage renal disease (ESRD). Both roxadustat and recombinant human erythropoietin (rhEPO) are alternative option for patients with renal anemia. However, the adverse events of rhEPO limited the wide use of it and the concrete difference of real clinical efficacy of rhEPO and roxadustat was still uncertain. This study aimed to assess the clinical efficacy of roxadustat for improving renal anemia in patients with chronic kidney disease.

          Methods

          A retrospective cohort study of 790 consecutive patients with renal anemia treated with roxadustat and rhEPO was conducted at the Zhejiang Provincial People’s Hospital. Patients were classified into two groups: roxadustat (n=95) and rhEPO (n=695). Baseline characteristics were compared in two groups. After propensity-score matching at a 1:3 ratio, we compared the efficacy of roxadustat and rhEPO in improving anemia, mainly using the Mann-Whitney U test. The follow-up period lasted 24 weeks.

          Results

          The baseline characteristics were comparable between the two groups after propensity-score matching. There were no significant differences in the hemoglobin levels and estimated glomerular filtration rates (eGFRs) of the two groups before roxadustat or rhEPO treatment (P>0.05). The hemoglobin level after 4 weeks of treatment was 96 g/L in the roxadustat group, and the increase from baseline was 10 g/L; in the rhEPO group, these values were 87 and 6 g/L, respectively (P<0.001). After 12 weeks of treatment, the hemoglobin level and change from baseline were 105 and 15 g/L in the roxadustat group and 94 and 11 g/L in the rhEPO group, respectively (P<0.001). Similar results were observed after 24 weeks of treatment; the hemoglobin level and change from baseline were 105 and 17 g/L in the roxadustat group and 97 and 14 g/L in the rhEPO group (P=0.001).

          Conclusions

          This retrospective study demonstrated that orally administered roxadustat improved hemoglobin levels more than rhEPO in patients with CKD and anemia.

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          2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes—2021

          (2020)
          The American Diabetes Association (ADA) "Standards of Medical Care in Diabetes" includes the ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee (https://doi.org/10.2337/dc21-SPPC), are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations, please refer to the Standards of Care Introduction (https://doi.org/10.2337/dc21-SINT). Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.
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            A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease.

            Marc Pfeffer, Emmanuel A. Burdmann, Chao-Yin Chen … (2009)
            Anemia is associated with an increased risk of cardiovascular and renal events among patients with type 2 diabetes and chronic kidney disease. Although darbepoetin alfa can effectively increase hemoglobin levels, its effect on clinical outcomes in these patients has not been adequately tested. In this study involving 4038 patients with diabetes, chronic kidney disease, and anemia, we randomly assigned 2012 patients to darbepoetin alfa to achieve a hemoglobin level of approximately 13 g per deciliter and 2026 patients to placebo, with rescue darbepoetin alfa when the hemoglobin level was less than 9.0 g per deciliter. The primary end points were the composite outcomes of death or a cardiovascular event (nonfatal myocardial infarction, congestive heart failure, stroke, or hospitalization for myocardial ischemia) and of death or end-stage renal disease. Death or a cardiovascular event occurred in 632 patients assigned to darbepoetin alfa and 602 patients assigned to placebo (hazard ratio for darbepoetin alfa vs. placebo, 1.05; 95% confidence interval [CI], 0.94 to 1.17; P=0.41). Death or end-stage renal disease occurred in 652 patients assigned to darbepoetin alfa and 618 patients assigned to placebo (hazard ratio, 1.06; 95% CI, 0.95 to 1.19; P=0.29). Fatal or nonfatal stroke occurred in 101 patients assigned to darbepoetin alfa and 53 patients assigned to placebo (hazard ratio, 1.92; 95% CI, 1.38 to 2.68; P<0.001). Red-cell transfusions were administered to 297 patients assigned to darbepoetin alfa and 496 patients assigned to placebo (P<0.001). There was only a modest improvement in patient-reported fatigue in the darbepoetin alfa group as compared with the placebo group. The use of darbepoetin alfa in patients with diabetes, chronic kidney disease, and moderate anemia who were not undergoing dialysis did not reduce the risk of either of the two primary composite outcomes (either death or a cardiovascular event or death or a renal event) and was associated with an increased risk of stroke. For many persons involved in clinical decision making, this risk will outweigh the potential benefits. (ClinicalTrials.gov number, NCT00093015.) 2009 Massachusetts Medical Society
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              Prevalence of chronic kidney disease in China: a cross-sectional survey.

              Luxia Zhang, Fang Wang, Li WANG … (2012)
              The prevalence of chronic kidney disease is high in developing countries. However, no national survey of chronic kidney disease has been done incorporating both estimated glomerular filtration rate (eGFR) and albuminuria in a developing country with the economic diversity of China. We aimed to measure the prevalence of chronic kidney disease in China with such a survey. We did a cross-sectional survey of a nationally representative sample of Chinese adults. Chronic kidney disease was defined as eGFR less than 60 mL/min per 1·73 m(2) or the presence of albuminuria. Participants completed a lifestyle and medical history questionnaire and had their blood pressure measured, and blood and urine samples taken. Serum creatinine was measured and used to estimate glomerular filtration rate. Urinary albumin and creatinine were tested to assess albuminuria. The crude and adjusted prevalence of indicators of kidney damage were calculated and factors associated with the presence of chronic kidney disease analysed by logistic regression. 50,550 people were invited to participate, of whom 47,204 agreed. The adjusted prevalence of eGFR less than 60 mL/min per 1·73 m(2) was 1·7% (95% CI 1·5-1·9) and of albuminuria was 9·4% (8·9-10·0). The overall prevalence of chronic kidney disease was 10·8% (10·2-11·3); therefore the number of patients with chronic kidney disease in China is estimated to be about 119·5 million (112·9-125·0 million). In rural areas, economic development was independently associated with the presence of albuminuria. The prevalence of chronic kidney disease was high in north (16·9% [15·1-18·7]) and southwest (18·3% [16·4-20·4]) regions compared with other regions. Other factors independently associated with kidney damage were age, sex, hypertension, diabetes, history of cardiovascular disease, hyperuricaemia, area of residence, and economic status. Chronic kidney disease has become an important public health problem in China. Special attention should be paid to residents in economically improving rural areas and specific geographical regions in China. The Ministry of Science and Technology (China); the Science and Technology Commission of Shanghai; the National Natural Science Foundation of China; the Department of Health, Jiangsu Province; the Sichuan Science and Technology Department; the Ministry of Education (China); the International Society of Nephrology Research Committee; and the China Health and Medical Development Foundation. Copyright © 2012 Elsevier Ltd. All rights reserved.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Transl Androl Urol
                Journal ID (iso-abbrev): Transl Androl Urol
                Journal ID (publisher-id): TAU
                Title: Translational Andrology and Urology
                Publisher: AME Publishing Company
                ISSN (Print): 2223-4683
                ISSN (Electronic): 2223-4691
                Publication date (Print and electronic): November 2022
                Publication date (Print): November 2022
                Volume: 11
                Issue: 11
                Pages: 1568-1576
                Affiliations
                [1 ]Urology & Nephrology Center, Department of Nephrology, Zhejiang Provincial People’s Hospital (Affiliated People’s Hospital, Hangzhou Medical College) , Hangzhou, China;
                [2 ]Bengbu Medical College , Bengbu, China;
                [3 ]deptDivision of Health Sciences , Hangzhou Normal University , Hangzhou, China;
                [4 ]deptDepartment of Nephrology , the First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine) , Hangzhou, China
                Author notes

                Contributions: (I) Conception and design: Q He, L Shao; (II) Administrative support: Y Li, B Zhu; (III) Provision of study materials or patients: C Jin, Y Ren, B Ye; (IV) Collection and assembly of data: C Jin, Y Zhang, C Luo; (V) Data analysis and interpretation: C Jin, Y Zhang, L Shao; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

                Correspondence to: Lina Shao. Urology & Nephrology Center, Department of Nephrology, Zhejiang Provincial People’s Hospital (Affiliated People’s Hospital, Hangzhou Medical College), Hangzhou 310014, China. Email: shaolina@ 123456hmc.edu.cn ; Qiang He. Department of Nephrology, the First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine), Hangzhou 310014, China. Email: qianghe1973@ 123456126.com .
                Article
                Publisher ID: tau-11-11-1568
                DOI: 10.21037/tau-22-709
                PMC ID: 9732703
                PubMed ID: 36507485
                SO-VID: 607a47a9-365d-4199-92f0-138ec9b380f7
                Copyright © 2022 Translational Andrology and Urology. All rights reserved.
                License:

                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
                Date received : 27 September 2022
                Date accepted : 17 November 2022
                Categories
                Subject: Original Article

                Keywords: roxadustat,erythropoietin,chronic kidney disease (ckd),anemia,propensity-score matching
                Data availability:
                Keywords: roxadustat, erythropoietin, chronic kidney disease (ckd), anemia, propensity-score matching

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