Randomized Equivalence Study Evaluating the Possibility of Switching Hemodialysis Patients Receiving Subcutaneous Human Erythropoietin Directly to Intravenous Darbepoetin Alfa
Randomized Equivalence Study Evaluating the Possibility of Switching Hemodialysis Patients Receiving Subcutaneous Human Erythropoietin Directly to Intravenous Darbepoetin Alfa
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DOI：
10.1345/aph.1k664
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发表时间：
2009-02-01
影响因子：
2.9
通讯作者：
Canaud, Bernard
中科院分区：
文献类型：
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作者：
Chazot, Charles;Terrat, Jean Claude;Canaud, Bernard
背景：Darbepoetin是一种促红细胞生成剂（ESA），可静脉注射或皮下注射，无剂量损失；然而，从皮下重组人促红细胞生成素（rHuEPO）直接转换到静脉注射达百培生成素的研究很少。目的：建立血液透析患者在皮下达贝泊汀治疗2个月后，直接从皮下rHuEPO切换到静脉注射达贝泊汀与间接从皮下rHuEPO切换到静脉注射达贝泊汀的等效性。方法：在这项开放、随机、为期6个月的前瞻性研究中，接受血液透析的终末期肾病患者被随机分为两组：直接从皮下rHuEPO切换到静脉注射达贝泊汀（1组），在皮下达贝泊汀治疗2个月后间接从皮下rHuEPO切换到静脉注射达贝泊汀（2组）。第三个非随机组（对照组），由静脉注射rHuEPO的患者转换为静脉注射达贝泊丁，也研究了从一种类型的ESA到另一种类型的ESA的变化，以反映血红蛋白（Hb）水平的可能变化。主要终点是6个月时Hb水平稳定的患者比例。次要终点包括第3个月时Hb的稳定性、达贝泊丁的剂量要求和给药途径的安全性。结果：在154名随机患者中，第1组和第2组Hb水平稳定的百分比分别在第3个月（86.0% vs 91.3%）和第6个月（82.1% vs 81.6%；差异为-0.5 [90% CI -12.8至11.8]）。在基线和第6个月之间，两组的平均Hb水平保持稳定，平均达贝泊丁剂量没有变化。在整个研究过程中，三组的平均铁蛋白水平保持在100 μ g/L以上，达贝泊丁耐受性良好。结论：该研究显示，直接从皮下rHuEPO切换到静脉注射darepoetin的患者在Hb稳定性方面具有相同的疗效，无需增加剂量。
BACKGROUND: Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA) used either intravenously or subcutaneously with no dose penalty; however, the direct switch from subcutaneous recombinant human erythropoietin (rHuEPO) to intravenous darbepoetin has barely been studied.OBJECTIVE: To establish the equivalence of a direct switch from subcutaneous rHuEPO to intravenous darbepoetin versus an indirect switch from subcutaneous rHuEPO to intravenous darbepoetin after 2 months of subcutaneous darbepoetin in patients undergoing hemodialysis.METHODS: In this open, randomized, 6-month, prospective study, patients with end-stage kidney disease who were on hemodialysis were randomized into 2 groups: direct switch from subcutaneous rHuEPO to intravenous darbepoetin (group 1) and indirect switch from subcutaneous rHuEPO to intravenous darbepoetin after 2 months of subcutaneous darbepoetin (group 2). A third, nonrandomized group (control), consisting of patients treated with intravenous rHuEPO who were switched to intravenous darbepoetin, was also studied to reflect possible variations of hemoglobin (Hb) levels due to change from one type of ESA to the other. The primary outcome was the proportion of patients with stable Hb levels at month 6. Secondary endpoints included Hb stability at month 3, dosage requirements for darbepoetin, and safety of the administration route.RESULTS: Among 154 randomized patients, the percentages with stable Hb levels were equivalent in groups 1 and 2, respectively, at month 3 (86.0% vs 91.3%) and month 6 (82.1 % vs 81.6%; difference -0.5 [90% CI -12.8 to 11.8]). Mean Hb levels between baseline and month 6 remained stable in both groups, with no variation in mean darbepoetin dose. Mean ferritin levels remained above 100 mu g/L in the 3 groups during the whole study, and darbepoetin was well tolerated.CONCLUSIONS: This study has shown equivalent efficacy on Hb stability without the need for dosage increase in patients switched directly from subcutaneous rHuEPO to intravenous darepoetin.