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The efficacy and safety of roxadustat treatment for anemia in patients with kidney disease: a meta-analysis and systematic review

  • Nephrology - Original Paper
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Abstract

Background

Anemia is a common complication for patients with kidney disease. Roxadustat is an oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (PHI), which is a newly approved oral drug for anemia. We performed this study to build evidence regarding efficacy and safety of roxadustat in kidney disease patients with or without dialysis.

Methods

We searched the databases of PubMed, Embase, Cochrane library and clinicaltrials.gov from the inception to July 20, 2020. The randomized controlled trials (RCTs) which compared roxadustat with placebo or other therapies in the treatment of anemia in kidney disease patients were included. Data were extracted from eligible studies and pooled in a meta-analysis model using RevMan5.3 and stata13.0 software.

Results

Eight RCTs with 1010 patients were included in our analysis. We found that roxadustat significantly increased hemoglobin (Hb) level (1.10 g/dL, 95% CI [0.52 g/dL, 1.67 g/dL], p = 0.0002), total iron-binding capacity (TIBC) (58.71 µg/dL, 95% CI [44.10 µg/dL, 73.32 µg/dL], p < 0.00001), iron level (9.28 µg/dL, 95% CI [0.11 µg/dL, 18.45 µg/dL], p = 0.05) compared with control group in kidney disease patients. In addition, our result showed that a significant reduction in hepcidin level (− 31.96 ng/mL, 95% CI [− 35.05 ng/mL, − 28.87 ng/mL], p < 0.00001), ferritin (− 44.82 ng/mL, 95% CI [− 64.42 ng/mL, − 25.23 ng/mL], p < 0.00001) was associated with roxadustat. No difference was found between roxadustat and control group in terms of oral iron supplementation, adverse events (AEs), serious adverse events (SAEs), infection, myocardial infraction, stroke, heart failure and death.

Conclusions

Roxadustat has higher mean Hb level than placebo or EPO. Due to the short follow-up period and the lack of critical data, more RCTs are needed to prove long-term safety and effectiveness of roxadustat in the future.

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Authors and Affiliations

  1. Department of Pharmacy, The Third Hospital of Hebei Medical University, 139 Ziqiang Road, Qiaoxi District, Shijiazhuang, 050051, Hebei Province, China

    Suhui Qie, Ning Jiao, Kunfeng Duan, Yang Liu & Guoqiang Liu

  2. Department of Chinese Pharmacy, Hebei Maternity Hospital, 27 Shifeng Road, Qiaoxi District, Shijiazhuang, 050051, Hebei Province, China

    Jingxin Li

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  1. Suhui Qie
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Contributions

GL and SQ conceived and designed study. NJ, KD, and JL made literature search, data extraction, data analysis, data interpretation. YL, GL and SQ assessed the quality of studies, drafting and critical revision of the manuscript. All authors had edited the draft, reviewed the manuscript and approved the final draft.

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Correspondence to Guoqiang Liu.

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Qie, S., Jiao, N., Duan, K. et al. The efficacy and safety of roxadustat treatment for anemia in patients with kidney disease: a meta-analysis and systematic review. Int Urol Nephrol 53, 985–997 (2021). https://doi.org/10.1007/s11255-020-02693-7

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