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首页> 外文期刊>Clinical journal of the American Society of Nephrology: CJASN >Cardiovascular safety and all-cause mortality of methoxy polyethylene glycol-epoetin beta and other erythropoiesis-stimulating agents in anemia of ckd a randomized noninferiority trial
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Cardiovascular safety and all-cause mortality of methoxy polyethylene glycol-epoetin beta and other erythropoiesis-stimulating agents in anemia of ckd a randomized noninferiority trial

机译：甲氧基聚乙二醇-epoetinβ和其他促红细胞刺激剂的心血管安全性和全导致的CKD A型随机性非血小毒试验中的促进剂

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ABSTRACT: Background and objectives Erythropoiesis-stimulating agents correct anemia of CKD but may increase cardiovascular risk. We compared cardiovascular outcomes and all-cause mortality associated with monthly methoxy polyethylene glycol-epoetin beta with those of the shorter-acting agents epoetin alfa/beta and darbepoetin alfa in patients with anemia of CKD. Design, setting, participants, & measurements We conducted a multicenter, open-label, noninferiority trial in which patients were randomized to receive methoxy polyethylene glycol-epoetin beta or reference erythropoiesis-stimulating agents, stratified by maintenance or correction treatment status and C-reactive protein level. The trial had a prespecified noninferiority margin of 1.20 for the hazard ratio (HR) for the primary end point (a composite of all-cause mortality, nonfatal myocardial infarction or stroke, adjudicated by an independent blinded committee). This trial is registered with ClinicalTrials.gov, number NCT00773513. Results In total, 2818 patients underwent randomization, received methoxy polyethylene glycol-epoetin beta or a reference agent, and were followed for a median of 3.4 years (maximum, 8.4 years). In the modified intention-to-treat analysis, a primary end point event occurred in 640 (45.4%) patients in the methoxy polyethylene glycol-epoetin beta arm, and 644 (45.7%) in the reference arm (HR 1.03; 95% confidence interval [95% CI], 0.93 to 1.15, P=0.004 for noninferiority). All-cause mortality was not different between treatment groups (HR 1.06; 95% CI, 0.94 to 1.19). Results in patient subgroups on dialysis or treated in the correction or maintenance settings were comparable to the primary analysis. Conclusions In patients with anemia of CKD, once-monthly methoxy polyethylene glycol-epoetin beta was noninferior to conventional, shorter-acting erythropoiesis-stimulating agents with respect to rates of major adverse cardiovascular events or all-cause mortality. ? 2019 by the American Society of Nephrology.
机译：摘要：背景和目标促红细胞刺激剂纠正CKD的贫血，但可能会增加心血管风险。我们将心血管结果和每月甲氧基聚乙二醇-epoetinβ相关的心血管结果和全导致死亡率与CKD的贫血患者的较短作用剂Epoetin Alfa /β和Darbopoetin Alfa相关联。设计，设定，参与者和测量我们进行了多中心，开放标签，非闭合性试验，其中患者被随机化以接受通过维持或校正治疗状态和C反应分层的甲氧基聚乙二醇 - 环丁蛋白β或参考促红细胞刺激剂。蛋白质水平。该试验为主要终点的危险比（HR）具有1.20的预先限制的非资格率，适用于主要终点（全导致死亡率，非致死性心肌梗死或中风的综合，由独立的盲委员会裁定）。此试验在ClinicalTrials.gov中注册，NCT00773513号码。结果总共2818名患者接受随机化，接受甲氧基聚乙二醇 - 环液蛋白酶β或参考剂，并进行3.4岁（最高，8.4岁）的中位数。在改进的意向治疗分析中，在甲氧基聚乙二醇 - 己酰甲蛋白β臂中的640（45.4％）患者中发生主要终点事件，以及参考臂中的644（45.7％）（HR 1.03; 95％的信心间隔[95％CI]，0.93至1.15，P = 0.004对于非侵入性）。治疗组之间的所有原因死亡率在（HR 1.06; 95％CI，0.94至1.19）之间没有差异。导致患者亚组透析或在校正或维护环境中处理的亚组与主要分析相当。结论CKD的贫血患者，每月甲氧基聚乙二醇-epoetinβ不具有常规，短发挥的促红细胞生成刺激剂，相对于主要不良心血管事件或全导致死亡率的速率。还2019年由美国肾脏学会。

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