Department of Nephrology, Showa University School of Medicine, Tokyo, Japan.
Medical Specialty, Japan Medical Affairs, Astellas Pharma, Inc., 2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8411, Japan.
Clin Exp Nephrol. 2022 Sep;26(9):843-850. doi: 10.1007/s10157-022-02225-w. Epub 2022 Apr 24.
Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for treating anemia of chronic kidney disease (CKD). This post hoc analysis of a Japanese, open-label, partially randomized, phase 3 study in patients with non-dialysis-dependent (NDD) CKD evaluated disease state-related parameters among patients with and without diabetes mellitus who received roxadustat. In the 1517-CL-0310 study (NCT02988973), roxadustat was noninferior to darbepoetin alfa for change in average hemoglobin levels at Weeks 18-24 from baseline who received roxadustat.
Patients enrolled in the 1517-CL-0310 study who received roxadustat were included in this post hoc analysis. Hematologic (hemoglobin, reticulocyte/erythrocyte ratio, mean corpuscular volume [MCV], and mean corpuscular hemoglobin [MCH]), iron-related (ferritin, total iron-binding capacity, transferrin, ceruloplasmin, and hepcidin), metabolic (HbA1c, glycated albumin, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol), and renal (eGFR) parameters were summarized descriptively by visit through Week 52.
Among 201 included patients, 105 (52.2%) and 96 (47.8%) were in the Diabetes and No Diabetes subgroups, respectively. There were no clinically meaningful differences through Week 52 for most hematologic, iron-related, metabolic, or renal parameters between patients in the Diabetes and No Diabetes subgroups. MCV and MCH remained lower and HbA1c and glycated albumin remained higher in patients in the Diabetes subgroup through Week 52. Both subgroups experienced a similar benefit from roxadustat in maintaining hemoglobin levels in the target range of 10-12 g/dL.
Roxadustat maintained hemoglobin levels in the target range with similar clinical parameters irrespective of diabetes mellitus presence at baseline.
罗沙司他是一种口服低氧诱导因子脯氨酰羟化酶抑制剂，用于治疗慢性肾脏病（CKD）贫血。本项日本、开放标签、部分随机、3 期研究的事后分析评估了接受罗沙司他治疗的非透析依赖型（NDD）CKD 患者中合并和不合并糖尿病患者的疾病相关参数。在 1517-CL-0310 研究（NCT02988973）中，罗沙司他在治疗 18-24 周期间的平均血红蛋白水平变化方面不劣于达贝泊汀α，并且这些患者接受了罗沙司他治疗。
本项事后分析纳入了 1517-CL-0310 研究中接受罗沙司他治疗的患者。通过第 52 周的访视，总结了血液学（血红蛋白、网织红细胞/红细胞比、平均红细胞体积 [MCV]和平均红细胞血红蛋白 [MCH]）、铁相关（铁蛋白、总铁结合能力、转铁蛋白、铜蓝蛋白和铁调素）、代谢（HbA1c、糖化白蛋白、总胆固醇、低密度脂蛋白胆固醇和高密度脂蛋白胆固醇）和肾脏（eGFR）参数，并进行描述性总结。
在纳入的 201 例患者中，105 例（52.2%）和 96 例（47.8%）患者分别进入糖尿病亚组和非糖尿病亚组。在第 52 周时，两组患者的大多数血液学、铁相关、代谢或肾脏参数之间没有临床意义的差异。在第 52 周时，糖尿病亚组的 MCV 和 MCH 仍然较低，HbA1c 和糖化白蛋白仍然较高。两组患者均从罗沙司他治疗中获益，使血红蛋白水平维持在 10-12 g/dL 的目标范围内。
无论基线时是否合并糖尿病，罗沙司他均能维持目标范围内的血红蛋白水平，且具有相似的临床参数。
