Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-Ku, Tokyo, 105-8461, Japan.
Research and Development, Bayer Yakuhin Ltd, 2-4-9 Umeda, Kita-Ku, Osaka, 530-0001, Japan.
Clin Exp Nephrol. 2023 Aug;27(8):651-659. doi: 10.1007/s10157-023-02353-x. Epub 2023 Apr 24.
Erythropoiesis-stimulating agents (ESAs) are the standard treatment for patients with renal anemia to increase hemoglobin (Hb) levels and reduce the need for blood transfusions. However, treatments targeting high Hb levels require high doses of ESAs administered intravenously, which is associated with an elevated risk of adverse cardiovascular events. Furthermore, there have been some problems such as hemoglobin variability and low achievement of target hemoglobin due to the shorter half-lives of ESAs. Consequently, erythropoietin-promoting medications, such as hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitors, have been developed. This study aimed to evaluate changes in the Treatment Satisfaction Questionnaire for Medicine version II (TSQM-II) domain scores relative to baseline in each trial, to assess patient satisfaction with molidustat versus darbepoetin alfa.
This post-hoc analysis of two clinical trials compared treatment satisfaction with an HIF-PH inhibitor, molidustat, versus a standard ESA, darbepoetin alfa, as part of therapy in patients with non-dialysis chronic kidney disease (CKD) and renal anemia.
Exploratory outcome data using the TSQM-II showed that both arms in both trials had enhanced treatment satisfaction over the course of the study period, as well as improvements in most TSQM-II domains at week 24 of treatment. Molidustat was associated with convenience domain scores at multiple time points depending on the trial. More patients were highly satisfied with the convenience of molidustat than that of darbepoetin alfa. Patients treated with molidustat had increased global satisfaction domain scores compared with those treated with darbepoetin alfa; however, the differences in global satisfaction domain scores were not significant.
These patient-reported satisfaction outcomes support the use of molidustat as a patient-centered treatment option for CKD-related anemia.
ClinicalTrials.gov Identifier: NCT03350321 (November 22, 2017).
gov Identifier: NCT03350347 (November 22, 2017).
促红细胞生成素刺激剂（ESAs）是治疗肾性贫血患者增加血红蛋白（Hb）水平和减少输血需求的标准治疗方法。然而，针对高 Hb 水平的治疗需要静脉内给予高剂量的 ESA，这与心血管不良事件的风险升高有关。此外，由于 ESA 的半衰期较短，存在一些问题，如血红蛋白变异性和目标血红蛋白水平的低达标率。因此，已经开发了促红细胞生成素促进药物，如缺氧诱导因子脯氨酰羟化酶（HIF-PH）抑制剂。本研究旨在评估与基线相比，每个试验中治疗满意度问卷（TSQM-II）各领域评分的变化，以评估莫立司他与达贝泊汀 α 的患者满意度。
这两项临床试验的事后分析比较了 HIF-PH 抑制剂莫立司他与标准 ESA 达贝泊汀 α 作为非透析慢性肾脏病（CKD）和肾性贫血患者治疗的一部分的治疗满意度。
使用 TSQM-II 的探索性结果数据表明，两项试验的两个治疗组在研究期间都提高了治疗满意度，并且在治疗的第 24 周时大多数 TSQM-II 领域都有所改善。根据试验的不同，莫立司他在多个时间点与便利性领域评分相关。与达贝泊汀 α 相比，更多的患者对莫立司他的便利性高度满意。与达贝泊汀 α 治疗的患者相比，接受莫立司他治疗的患者的全球满意度领域评分更高；然而，全球满意度领域评分的差异没有统计学意义。
这些患者报告的满意度结果支持将莫立司他作为 CKD 相关贫血的以患者为中心的治疗选择。
ClinicalTrials.gov 标识符：NCT03350321（2017 年 11 月 22 日）。
gov 标识符：NCT03350347（2017 年 11 月 22 日）。
