低氧诱导因子脯氨酸酰羟化酶抑制剂(HIF-PHIs)是开发用于治疗与慢性肾脏疾病(CKD)相关的贫血的新药。这类药物刺激内源性促红细胞生成素的产生,同时,改善铁的吸收和铁储存的动员(daprodustat不太明显,vadadustat和enarodustat)。在过去的几年中,已经发表了几项研究,表明这些药物在纠正与CKD相关的贫血方面并不劣于标准疗法。HIF-PHI的功效与与标准红细胞生成刺激剂(ESA)治疗相当的安全性特征相关。然而,HIF-PHIs的研究时间不足以明确排除新药对不良事件的影响,比如癌症,死亡和可能的心血管事件,这通常是在长期随访后发生的。肾脏疾病:改善全球结果(KDIGO)最近报道了2021年举行的HIF-PHI争议会议的结论。意大利肾脏病学会认可的本立场文件的目标是通过审查HIF-PHIs的疗效和安全性以及它们在感兴趣的亚群中的使用,更好地适应最新的KDIGOHIF-PHIs会议的结论。
Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) are new drugs developed for the treatment of anemia associated with chronic kidney disease (CKD). This class of drugs stimulates endogenous erythropoietin production and, at the same time, improves iron absorption and mobilization of iron stores (less evident with daprodustat, vadadustat and enarodustat). Several studies have been published in the last few years showing that these agents are not inferior to standard therapy in correcting anemia associated with CKD. The efficacy of HIF-PHIs is coupled with a safety profile comparable to that of standard erythropoiesis stimulating agent (ESA) treatment. However, studies with HIF-PHIs were not long enough to definitively exclude the impact of new drugs on adverse events, such as cancer, death and possibly cardiovascular events, that usually occur after a long follow-up period. Kidney Disease: Improving Global Outcomes (KDIGO) recently reported the conclusions of the Controversies Conference on HIF-PHIs held in 2021. The goal of the present position paper endorsed by the Italian Society of Nephrology is to better adapt the conclusions of the latest KDIGO Conference on HIF-PHIs to the Italian context by reviewing the efficacy and safety of HIF-PHIs as well as their use in subpopulations of interest as emerged from more recent publications not discussed during the KDIGO Conference.