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治疗慢性肾脏病相关贫血的 HIF 脯氨酰羟化酶抑制剂恩莱瑞司他:证据回顾。

Treatment of anemia associated with chronic kidney disease with the HIF prolyl hydroxylase inhibitor enarodustat: A review of the evidence.

机构信息

Medical Affairs Department, Torii Pharmaceutical Co. Ltd, Tokyo, Japan.

Pharmaceutical Division, Japan Tobacco Inc, Tokyo, Japan.

出版信息

Ther Apher Dial. 2022 Aug;26(4):679-693. doi: 10.1111/1744-9987.13820. Epub 2022 Mar 7.

DOI:10.1111/1744-9987.13820
PMID:35218616
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9539985/
Abstract

Enarodustat, a newly developed hypoxia-inducible factor prolyl hydroxylase inhibitor, is used in clinical practice in Japan. Several clinical studies showed that enarodustat corrected and maintained hemoglobin (Hb) levels by stimulating endogenous erythropoietin production and improving iron utilization in anemic patients with chronic kidney disease, regardless of whether they were on dialysis. In addition, Phase III comparative studies demonstrated that enarodustat was noninferior to darbepoetin alfa in controlling Hb levels. Furthermore, enarodustat was well tolerated during the treatment. Enarodustat is currently being developed in the Republic of Korea and China and is expected to be developed worldwide. This article reviews the data on enarodustat, including the findings from preclinical studies, pharmacokinetics/pharmacodynamics, and efficacy and safety results of clinical studies.

摘要

依罗尤单抗,一种新研发的低氧诱导因子脯氨酰羟化酶抑制剂,已在日本的临床实践中使用。多项临床研究表明,依罗尤单抗通过刺激内源性促红细胞生成素的产生和改善铁的利用,可纠正和维持贫血的慢性肾脏病患者的血红蛋白(Hb)水平,无论其是否接受透析。此外,III 期对照研究表明,依罗尤单抗在控制 Hb 水平方面不劣于达贝泊汀α。此外,依罗尤单抗在治疗期间耐受性良好。依罗尤单抗目前正在韩国和中国开发,并有望在全球范围内开发。本文综述了依罗尤单抗的数据,包括临床前研究、药代动力学/药效学以及临床研究的疗效和安全性结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f9d/9539985/223dcfc84fe1/TAP-26-679-g002.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f9d/9539985/7dcbff95d961/TAP-26-679-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f9d/9539985/9a831df5c64f/TAP-26-679-g003.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f9d/9539985/f9dc593ed9a3/TAP-26-679-g007.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f9d/9539985/223dcfc84fe1/TAP-26-679-g002.jpg

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Two long-term phase 3 studies of enarodustat (JTZ-951) in Japanese anemic patients with chronic kidney disease not on dialysis or on maintenance hemodialysis: SYMPHONY ND-Long and HD-Long studies.
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