Mann J F E, de Francisco A, Nassar G, Canaud B
KfH Kidney Center, Munich, and Department of Medicine IV, University of Erlangen-Nurnberg, Germany.
Clin Nephrol. 2011 Jul;76(1):9-15. doi: 10.5414/cn106847.
Frequent dosing and requirements for dose adjustments of erythropoiesis-stimulating agents (ESAs) create significant burdens for healthcare providers and have been associated with hemoglobin (Hb) cycling, hampering maintenance of target Hb levels. We compared the frequency of dose changes in dialysis patients who received methoxy polyethylene glycolepoetin beta; (a continuous erythropoietin receptor activator (C.E.R.A.)) or a shorter-acting ESA.
Data were analyzed from three Phase III maintenance trials, using almost identical protocols, in dialysis patients treated with C.E.R.A. every 2 weeks (q2w) or every 4 weeks (q4w) or a comparator ESA (epoetin or darbepoetin alpha; at their previous dose/administration interval). Dosage was adjusted to maintain Hb ± 1 g/dl of baseline and 10 - 13.5 g/dl during titration (28 weeks) and evaluation (8 weeks), and 11 - 13 g/dl during follow-up (16 weeks).
Data were analyzed from 564 patients treated with C.E.R.A. q2w, 410 with C.E.R.A. q4w and 572 with comparator ESA at their usual dosing interval. Significantly fewer dose changes were needed in patients receiving C.E.R.A. q2w (p < 0.05) or C.E.R.A. q4w (p < 0.001) than in patients treated with comparator ESAs.
This retrospective analysis suggests that C.E.R.A. q4w maintains Hb levels in dialysis patients and requires fewer dose changes compared with other ESAs.
促红细胞生成素刺激剂（ESA）频繁给药及剂量调整需求给医疗服务提供者带来了沉重负担，并与血红蛋白（Hb）波动相关，阻碍了目标Hb水平的维持。我们比较了接受甲氧基聚乙二醇化促红细胞生成素β（一种持续促红细胞生成素受体激活剂（C.E.R.A.））或短效ESA的透析患者的剂量变化频率。
对三项III期维持试验的数据进行分析，这些试验采用几乎相同的方案，涉及接受每2周（q2w）或每4周（q4w）一次C.E.R.A.治疗的透析患者，或接受对照ESA（依泊汀或达贝泊汀α，按其先前剂量/给药间隔）治疗的透析患者。在滴定期（28周）和评估期（8周）将剂量调整为维持Hb在基线水平±1 g/dl且在10 - 13.5 g/dl之间，在随访期（16周）维持在11 - 13 g/dl之间。
分析了564例每2周接受一次C.E.R.A.治疗、410例每4周接受一次C.E.R.A.治疗以及572例按常规给药间隔接受对照ESA治疗的患者的数据。接受每2周一次C.E.R.A.治疗（p < 0.05）或每4周一次C.E.R.A.治疗（p < 0.001）的患者所需的剂量变化明显少于接受对照ESA治疗的患者。
这项回顾性分析表明，与其他ESA相比，每4周一次的C.E.R.A.可维持透析患者的Hb水平，且所需的剂量变化更少。
