瓦达斯塔特每周三次用于由于透析依赖的CKD导致贫血的患者
Hakan R Toka1, Marializa Bernardo2, Steven K Burke3
1Nova Clinical Research, LLC, Bradenton, FL.
概括
低氧诱导因子酸酶抑制剂 (HIF-PHI),如瓦达杜斯塔特,为慢性病 (CKD) 中的贫血提供了ESAs的有效替代品. 这项研究发现,达斯塔特在维持血红蛋白水平方面与MPG-EPO不逊色,具有类似的安全性.
科学领域:
- 腎病學和血液學.
- 药理学和治疗学 药理学和治疗学
背景情况:
- 慢性病 (CKD) 中的贫血通常用红色素形成刺激剂 (ESA) 治疗.
- 低氧诱导因子酸酶抑制剂 (HIF-PHI) 是一种用于贫血管理的新型口服治疗类.
- 甲基聚乙烯甘醇-乙烯-β (MPG-EPO) 是一种长效注射ESA.
研究的目的:
- 为了比较从MPG-EPO转换为口服HIF-PHI的有效性和安全性,与继续MPG-EPO维持疗法相比.
- 评估瓦达杜斯塔特在维持透析依赖性慢性病患者的血红蛋白水平方面的非劣势.
主要方法:
- 3b期,开放标签,非劣势性,多中心试验,涉及456名患有贫血和透析依赖性CKD的成年参与者.
- 参与者被随机分配给接受瓦达杜沙特 (600毫克或900毫克每周三次) 或MPG-EPO,长达52周.
- 疗效终点包括血红蛋白度的平均变化;安全终点包括治疗出现的不良事件.
主要成果:
- 瓦达杜沙特 (组合剂量) 在维持血红蛋白水平方面与MPG-EPO相比,在初级和二级评估期间均不劣.
- 血红蛋白水平在各组保持稳定,在低剂量瓦达杜斯塔特组的最初短暂下降,在第12周稳定下来.
- 治疗出现的不良事件和严重不良事件的发生率在瓦达杜沙特和MPG-EPO组之间是相似的.
结论:
- 每周三次的瓦达斯塔特在治疗透析依赖性慢性病患者的贫血方面表现出与MPG-EPO相比的非劣势.
- 瓦达杜斯塔特为这种患者群体提供了一种安全有效的口服替代注射ESA.
- 可能需要进一步调查以澄清不良事件归因中的潜在错误.
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