贫血是慢性肾脏疾病（CKD）常见并伴随有不良的生活质量和心血管结局的病症，其治疗对卫生保健系统来说也是一个重要的经济负担。尽管治疗有效，但目前慢性肾脏疾病患者的贫血治疗标准是使用红细胞生成刺激因子进行持续注射，这使得治疗对于非在中心维持血液透析的患者而言更难以接受或实现。此外，安全隐患也出现在红细胞计数保持正常或接近正常水平的研究中，包括心血管事件和死亡风险增加。口服有效的缺氧诱导因子羟化酶抑制剂vadadustat可以通过激活内源性促红细胞生成素产生途径来纠正贫血，可能优于红细胞生成刺激因子的作用。 为了全面分析强效vadadustat在依赖透析和非依赖透析的CKD相关贫血患者中的安全资料，我们汇总了第3期临床试验计划中每个治疗组的安全人口（n=7,373），并比较了每个治疗组的治疗相关不良事件（TEAEs）的风险。 在随机接受vadadustat和达比诺臂丙的患者中，TEAE速率（88.9% vs 89.3%），治疗相关严重不良事件（58.0% vs 59.3%）和导致死亡的TEAE速率（16.1% vs 16.2%）相似，特别是与心血管、肝脏和肿瘤相关的不良事件的比率也相似。 对于使用vadadustat治疗的与CKD相关的贫血患者，我们观察到相对于使用达比诺臂丙患者的不良事件速率相似。© 2022作者。由巴塞尔的Karger AG出版。

Anemia frequently occurs in chronic kidney disease (CKD), is associated with poor quality of life and cardiovascular outcomes, and its treatment represents a considerable economic burden to the healthcare system. Although effective, the current standard of care for the treatment of anemia in chronic kidney disease patients with erythropoiesis-stimulating agents requires chronic/ongoing injections, making the treatment less accessible or desirable to patients not treated by in-center maintenance hemodialysis. Furthermore, safety concerns, including an increased risk of cardiovascular events and mortality, have emerged from their use in studies targeting hemoglobin concentrations in the normal or near-normal range. The orally active hypoxia-inducible factor prolyl hydroxylase inhibitor vadadustat may offer advantages over erythropoiesis-stimulating agents by correcting anemia via pathways activating endogenous erythropoietin production.To comprehensively analyze the safety profile of vadadustat in patients with dialysis-dependent and non-dialysis-dependent CKD-related anemia, we pooled the safety populations from each of the four trials in the phase 3 clinical program (n = 7,373) and compared the risk of treatment-emergent adverse events (TEAEs) for each treatment arm.In patients randomized to vadadustat versus darbepoetin alfa, rates of TEAEs (88.9% vs. 89.3%), treatment-emergent serious adverse events (58.0% vs. 59.3%), and TEAEs leading to death (16.1% vs. 16.2%) were similar, as were rates of adverse events of special interest, including cardiovascular-, hepatic-, and neoplasm-related adverse events.Among patients with CKD-related anemia treated with vadadustat, we observed similar rates of adverse events relative to those treated with darbepoetin alfa.© 2022 The Author(s). Published by S. Karger AG, Basel.