UNASSIGNED: This article provides a comprehensive review of the latest literature, with a particular focus on the effectiveness and safety of vadadustat.
UNASSIGNED: A phase 3, randomized, open-label, clinical trial (PRO2TECT) demonstrated that vadadustat had the prespecified non-inferiority for hematologic efficacy as compared with darbepoetin alfa in non-dialysis-dependent patients not previously treated with ESA. However, vadadustat did not show non-inferiority in major adverse cardiovascular events in the non-US/non-Europe patients. It may partly because of imbalances of the baseline eGFR level in those countries. In dialysis-dependent patients, a phase 3 clinical trial (INNO2VATE) showed vadadustat was non-inferior to darbepoetin alfa in cardiovascular safety and maintenance of hemoglobin levels. Adverse events including cancer, retinopathy, thrombosis, and vascular calcification should be evaluated in future clinical studies.
■本文提供了对最新文献的全面回顾,特别关注vadadustat的有效性和安全性。
■第三阶段,随机,开放标签,临床试验(PRO2TECT)表明,在先前未接受ESA治疗的非透析依赖患者中,与darbepoetinalfa相比,vadadustat在血液学疗效方面具有预设的非劣效性.然而,在非美国/非欧洲患者中,vadadustat在主要不良心血管事件中未显示非劣效性。部分原因可能是这些国家eGFR基线水平的不平衡。在透析依赖患者中,一项3期临床试验(INNO2VATE)显示,vadadustat在心血管安全性和血红蛋白水平维持方面不劣于darbepoietinalfa.不良事件包括癌症,视网膜病变,血栓形成,血管钙化应在未来的临床研究中进行评估。