Division of Nephrology, Ikegami General Hospital, Medical Corporation SHOWAKAI, Tokyo, Japan.
Ther Apher Dial. 2022 Apr;26(2):357-361. doi: 10.1111/1744-9987.13717. Epub 2021 Aug 3.
Roxadustat is one of the oral hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) that stimulates erythropoiesis and regulates the genes related to iron metabolism. The treatment of HIF-PHIs is useful compared with that of erythropoietin stimulating agent (ESA) using various instruments and procedures. Few clinical researchers have examined the efficacy and safety of switching treatment from Darbepoetin to Roxadustat in Japanese hemodialysis (HD) patients. However, HIF-PHIs have severe adverse drug reactions, such as thrombotic events. In the present study, we evaluated the lower dose of roxadustat in HD patients receiving high dose of ESA therapy. Eighteen anemic HD patients receiving an ESA, that is,, darbepoetin over 40 μg per week, were enrolled in this study. The treatment of these patients was changed to 20 mg of roxadustat three times weekly for 6 months, after which doses were adjusted to achieve a hemoglobin (Hb) target of 10.0-12.0 g/dL. An increase of 58.1 ± 32.5 mg roxadustat three times weekly increased Hb. It also achieved and then maintained levels within the target range at month 6. Ferritin levels of more than 100 ng/mL or TSAT levels of more than 20% were maintained during the 6-month treatment periods with oral or intravenous iron supplementation. It seems unnecessary to increase the initial dose of roxadustat for patients using high doses of ESA. It is suggested that a reconsideration of the starting dose of roxadustat in Japanese HD patients is needed. (Ikegami General Hospital, Medical Corporation SHOWAKAI、Approval number: 2020-4).
罗沙司他是一种口服低氧诱导因子脯氨酰羟化酶抑制剂(HIF-PHI),可刺激红细胞生成并调节与铁代谢相关的基因。与使用各种仪器和程序的促红细胞生成素刺激剂(ESA)治疗相比,HIF-PHI 的治疗效果更优。很少有临床研究人员检查过将治疗从达贝泊汀转换为罗沙司他在日本血液透析(HD)患者中的疗效和安全性。然而,HIF-PHI 有严重的药物不良反应,如血栓事件。在本研究中,我们评估了 HD 患者接受高剂量 ESA 治疗时使用较低剂量罗沙司他的效果。18 名接受 ESA(即每周达贝泊汀超过 40μg)治疗的贫血 HD 患者入组本研究。这些患者的治疗方案改为每周 3 次 20mg 罗沙司他,持续 6 个月,然后根据需要调整剂量,以达到 10.0-12.0g/dL 的血红蛋白(Hb)目标值。每周增加 58.1±32.5mg 罗沙司他可使 Hb 增加,并在第 6 个月时达到并维持目标范围内的水平。在 6 个月的口服或静脉铁补充治疗期间,铁蛋白水平超过 100ng/mL 或转铁蛋白饱和度(TSAT)水平超过 20%。对于使用高剂量 ESA 的患者,似乎没有必要增加罗沙司他的初始剂量。建议需要重新考虑日本 HD 患者使用罗沙司他的起始剂量。(日本 SHOWAKAI 医疗公司生协有明医院、批准号:2020-4)。