Alsalimy Noor, Awaisu Ahmed
Geriatrics Section, Rumailah Hospital, P.O. Box 3050, Doha, Qatar.
Int J Clin Pharm. 2014 Dec;36(6):1115-25. doi: 10.1007/s11096-014-0023-x. Epub 2014 Oct 7.
Anemia management in non-dialysis-dependent chronic kidney disease (CKD) patients is associated with cardiovascular and cost benefits, slows decline in renal function, and prevents mortality. Different reviews have focused on evaluating the safety and efficacy of methoxy polyethylene glycol-epoetin beta (MPG-EPO), a continuous erythropoietin receptor activator, in CKD patients regardless of dialysis dependency and others have studied this novel agent exclusively in CKD patients receiving dialysis.
To evaluate the efficacy and tolerability of MPG-EPO compared with other erythropoiesis stimulating agents (in particular darbepoetin alfa) for the treatment of anemia in non-dialysis-dependent CKD patients.
A systematic review of original studies published mainly in MEDLINE, Cochrane Database, ScienceDirect, ProQuest, clinical trials registries, and Google Scholar was carried out to identify randomized controlled trials (RCTs) comparing MPG-EPO with other erythropoiesis stimulating agents or placebo among patients with anemia of CKD who were not yet receiving dialysis. Data were independently extracted by two reviewers using standardized data abstraction tool.
Four trials involving 1,155 patients were included in the review. The changes in hemoglobin level from the baseline reported by the reviewed studies demonstrate that MPG-EPO was clinically non-inferior to darbepoetin alfa. In addition, the studies documented that MPG-EPO-treated patients experienced a lower rate of hemoglobin level above the target range of 12-13 g/dL than darbepoetin-treated patients. The proportion of patients requiring RBC transfusion was higher among patients who received darbepoetin alfa than those who received MPG-EPO. However, the time to hemoglobin response was longer with MPG-EPO than with darbepoetin. Finally, the incidences of serious adverse events were similar between the two therapeutic agents.
There are currently only few well-designed head-to-head RCTs investigating the efficacy and safety of MPG-EPO compared with other ESAs in non-dialysis-dependent patients. MPG-EPO therapy compared with darbepoetin alfa has demonstrated favorable effects of increasing and maintaining hemoglobin concentrations to recommended target levels. This mini-review is not conclusive due to limited number of studies. Therefore, the beneficial effects and tolerability of MPG-EPO among non-dialysis-dependent CKD patients should be further investigated, given the economic and clinical benefits of managing anemia in this population.
非透析依赖型慢性肾脏病（CKD）患者的贫血管理与心血管益处和成本效益相关，可减缓肾功能下降，并预防死亡。不同的综述聚焦于评估持续促红细胞生成素受体激活剂甲氧基聚乙二醇 - 促红细胞生成素β（MPG - EPO）在CKD患者中的安全性和疗效，无论其是否依赖透析，而其他综述则专门在接受透析的CKD患者中研究了这种新型药物。
评估MPG - EPO与其他促红细胞生成刺激剂（特别是阿法达贝泊汀）相比，用于治疗非透析依赖型CKD患者贫血的疗效和耐受性。
对主要发表在MEDLINE、Cochrane数据库、ScienceDirect、ProQuest、临床试验注册库和谷歌学术上的原始研究进行系统综述，以识别在尚未接受透析的CKD贫血患者中比较MPG - EPO与其他促红细胞生成刺激剂或安慰剂的随机对照试验（RCT）。两名审阅者使用标准化数据提取工具独立提取数据。
该综述纳入了四项涉及1155名患者的试验。综述研究报告的血红蛋白水平相对于基线的变化表明，MPG - EPO在临床上不劣于阿法达贝泊汀。此外，研究记录显示，接受MPG - EPO治疗的患者血红蛋白水平高于12 - 13 g/dL目标范围的发生率低于接受阿法达贝泊汀治疗的患者。接受阿法达贝泊汀治疗的患者中需要红细胞输血的比例高于接受MPG - EPO治疗的患者。然而，MPG - EPO达到血红蛋白反应的时间比阿法达贝泊汀更长。最后，两种治疗药物的严重不良事件发生率相似。
目前仅有少数设计良好的头对头随机对照试验研究了MPG - EPO与其他促红细胞生成素类似物在非透析依赖型患者中的疗效和安全性。与阿法达贝泊汀相比，MPG - EPO治疗已显示出将血红蛋白浓度提高并维持在推荐目标水平的有利效果。由于研究数量有限，本小型综述尚无定论。因此，鉴于管理该人群贫血的经济和临床益处，MPG - EPO在非透析依赖型CKD患者中的有益效果和耐受性应进一步研究。
