PMID- 34428860 OWN - NLM STAT- MEDLINE DCOM- 20220426 LR - 20220426 IS - 1365-2125 (Electronic) IS - 0306-5251 (Linking) VI - 88 IP - 3 DP - 2022 Mar TI - Efficacy and safety of roxadustat for anaemia in dialysis-dependent and non-dialysis-dependent chronic kidney disease patients: A systematic review and meta-analysis. PG - 919-932 LID - 10.1111/bcp.15055 [doi] AB - AIMS: Renal anaemia is a common complication of chronic kidney disease (CKD). Roxadustat is the first-in-class oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anaemia. In this systematic review, we aimed to investigate the efficacy and safety of roxadustat in the treatment of anaemia in CKD patients. METHODS: PubMed, Cochrane Library, Embase, and ClinicalTrials.gov databases were searched from their inception to February 2021 for randomised controlled trials (RCTs) that compared the efficacy and safety of roxadustat to those of an erythropoiesis-stimulating agent (ESA) or a placebo in treating anaemia in CKD patients. RESULTS: Nine RCTs involving 2743 patients were found. The meta-analysis showed that roxadustat increased haemoglobin (Hb) level by 0.91 g/dL (95% confidence interval [CI]: 0.47-1.34, P < .05), transferrin level by 0.50 mg/dL (95% CI: 0.34-0.65, P < .05), and total iron-binding capacity by 50.64 mug/dL (95% CI: 36.21-65.07, P < .05) in CKD patients. Decreases in hepcidin (mean difference [MD] = -23.16, 95% CI: -37.12 to -9.19, P < .05) and ferritin (MD = -38.35, 95% CI: -67.41 to -9.29, P < .05) levels were also observed. There was no significant difference in the incidence of adverse events (AEs) (OR: 1.12, 95% CI: 0.95-1.32, P = .17) between the roxadustat and control groups; however, the incidence of serious AEs in the roxadustat group was significantly higher than that in the ESA group (OR: 1.33, 95% CI: 1.06-1.68, P < .05). CONCLUSION: Roxadustat can significantly improve renal anaemia in CKD patients by increasing Hb level and iron metabolism. However, attention must be paid to the risk of SAEs during treatment. CI - (c) 2021 British Pharmacological Society. FAU - Zheng, Li AU - Zheng L AUID- ORCID: 0000-0003-0971-0343 AD - Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China. AD - Department of Pharmacy, China Aerospace Science & Industry Corporation 731 Hospital, Beijing, China. FAU - Tian, Jinhui AU - Tian J AUID- ORCID: 0000-0002-0054-2454 AD - Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China. FAU - Liu, Deping AU - Liu D AUID- ORCID: 0000-0001-5887-4120 AD - Department of Cardiovascular Medicine, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China. FAU - Zhao, Yan AU - Zhao Y AD - Department of Pharmacy, China Aerospace Science & Industry Corporation 731 Hospital, Beijing, China. FAU - Fang, Xiaoyong AU - Fang X AD - Department of Pharmacy, China Aerospace Science & Industry Corporation 731 Hospital, Beijing, China. FAU - Zhang, Yatong AU - Zhang Y AD - Department of Pharmacy, Beijing Hospital, Beijing, China. FAU - Liu, Yuming AU - Liu Y AD - Department of Endocrinology and Metabolism and Nephropathy, China Aerospace Science & Industry Corporation 731 Hospital, Beijing, China. LA - eng PT - Journal Article PT - Meta-Analysis PT - Research Support, Non-U.S. Gov't PT - Review PT - Systematic Review DEP - 20210930 PL - England TA - Br J Clin Pharmacol JT - British journal of clinical pharmacology JID - 7503323 RN - 0 (Hematinics) RN - 0 (Isoquinolines) RN - E1UOL152H7 (Iron) RN - TE7660XO1C (Glycine) RN - X3O30D9YMX (roxadustat) SB - IM MH - *Anemia/drug therapy/etiology MH - Female MH - Glycine/analogs & derivatives MH - *Hematinics/adverse effects MH - Humans MH - Iron MH - Isoquinolines MH - Male MH - Renal Dialysis/adverse effects MH - *Renal Insufficiency, Chronic/drug therapy/therapy OTO - NOTNLM OT - chronic kidney disease OT - meta-analysis OT - renal anaemia OT - roxadustat EDAT- 2021/08/25 06:00 MHDA- 2022/04/27 06:00 CRDT- 2021/08/24 20:29 PHST- 2021/08/08 00:00 [revised] PHST- 2021/04/15 00:00 [received] PHST- 2021/08/12 00:00 [accepted] PHST- 2021/08/25 06:00 [pubmed] PHST- 2022/04/27 06:00 [medline] PHST- 2021/08/24 20:29 [entrez] AID - 10.1111/bcp.15055 [doi] PST - ppublish SO - Br J Clin Pharmacol. 2022 Mar;88(3):919-932. doi: 10.1111/bcp.15055. Epub 2021 Sep 30.