The Phosphate Binder Ferric Citrate and Mineral Metabolism and Inflammatory Markers in Maintenance Dialysis Patients: Results From Prespecified Analyses of a Randomized Clinical Trial.
The Phosphate Binder Ferric Citrate and Mineral Metabolism and Inflammatory Markers in Maintenance Dialysis Patients: Results From Prespecified Analyses of a Randomized Clinical Trial.
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维持性透析患者的磷酸盐结合剂柠檬酸铁、矿物质代谢和炎症标志物：随机临床试验的预先指定分析结果。
DOI：
10.1053/j.ajkd.2015.03.013
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发表时间：
2015
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We
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作者：
VanBuren,PeterN;Lewis,JuliaB;Dwyer,JamieP;Greene,Tom;Middleton,John;Sika,Mohammed;Umanath,Kausik;Abraham,JosephineD;Arfeen,ShahabulS;Bowline,IsaiG;Chernin,Gil;Fadem,StephenZ;Goral,Simin;Koury,Mark;Sinsakul,MarvinV;We
背景磷酸盐结合剂是治疗透析患者高磷血症的基石。柠檬酸铁是一种铁基口服磷酸盐粘合剂，能有效地降低血磷水平。研究设计为期52周，开放标签，3期，随机对照试验，用于安全性评估。设置和参与者：洗涤之前的磷酸盐粘合剂后，维持血磷水平在≥6.0m g/dL的透析患者。干预2：1随机分为柠檬酸铁组和主动对照组(西维拉姆碳酸盐和/或醋酸钙)。结果：1年后矿物质骨病、蛋白能量消耗/炎症和不良事件的发生。测定血清钙、完整甲状旁腺激素、磷、铝、白细胞计数、淋巴细胞百分比、血清氮、尿素和/或醋酸钙结果有292名参与者被随机分配到柠檬酸铁组，149名参与者被随机分配到积极对照组。两个组之间的关系很好。从基线的平均变化来看，柠檬酸铁组和活动对照组的磷水平下降幅度相似(−2.04±0.99[SD]vs−2.18±2.25 mg/dL；P=0.09)；血清钙水平在柠檬酸铁组和活动对照组类似地升高(0.22±0.90 vs 0.31±0.95 mg/dL；P=0.02)。4名服用醋酸钙的受试者出现高钙血症。柠檬酸铁组和主动对照组甲状旁腺激素水平下降相似(−167.1±399.8 vs−152.7±392.1 pg/mL；P=0.08)。血清白蛋白、碳酸氢盐、血清尿素氮、白细胞计数和淋巴细胞百分率、铝值，柠檬酸铁组与对照组相似。服用西维拉姆的参与者的总和低密度脂蛋白胆固醇水平低于服用柠檬酸铁和醋酸钙的参与者。限制开放标签研究，腹膜透析患者较少。结论与主动对照相比，柠檬酸铁控磷作用相似，对透析患者骨和矿物质代谢指标的影响相似。没有证据表明蛋白质能量浪费/炎症或铝中毒，随机分配到柠檬酸铁组的参与者较少发生严重不良事件。柠檬酸铁是一种有效的磷酸盐粘结剂，其安全性可与七叶胶和醋酸钙相媲美。
BackgroundPhosphate binders are the cornerstone of hyperphosphatemia management in dialysis patients. Ferric citrate is an iron-based oral phosphate binder that effectively lowers serum phosphorus levels.Study Design52-week, open-label, phase 3, randomized, controlled trial for safety-profile assessment.Setting & ParticipantsMaintenance dialysis patients with serum phosphorus levels ≥6.0 mg/dL after washout of prior phosphate binders.Intervention2:1 randomization to ferric citrate or active control (sevelamer carbonate and/or calcium acetate).OutcomesChanges in mineral bone disease, protein-energy wasting/inflammation, and occurrence of adverse events after 1 year.MeasurementsSerum calcium, intact parathyroid hormone, phosphorus, aluminum, white blood cell count, percentage of lymphocytes, serum urea nitrogen, and bicarbonate.ResultsThere were 292 participants randomly assigned to ferric citrate, and 149, to active control. Groups were well matched. For mean changes from baseline, phosphorus levels decreased similarly in the ferric citrate and active control groups (−2.04 ± 1.99 [SD] vs −2.18 ± 2.25 mg/dL, respectively;P= 0.9); serum calcium levels increased similarly in the ferric citrate and active control groups (0.22 ± 0.90 vs 0.31 ± 0.95 mg/dL;P= 0.2). Hypercalcemia occurred in 4 participants receiving calcium acetate. Parathyroid hormone levels decreased similarly in the ferric citrate and active control groups (−167.1 ± 399.8 vs −152.7 ± 392.1 pg/mL;P= 0.8). Serum albumin, bicarbonate, serum urea nitrogen, white blood cell count and percentage of lymphocytes, and aluminum values were similar between ferric citrate and active control. Total and low-density lipoprotein cholesterol levels were lower in participants receiving sevelamer than those receiving ferric citrate and calcium acetate. Fewer participants randomly assigned to ferric citrate had serious adverse events compared with active control.LimitationsOpen-label study, few peritoneal dialysis patients.ConclusionsFerric citrate was associated with similar phosphorus control compared to active control, with similar effects on markers of bone and mineral metabolism in dialysis patients. There was no evidence of protein-energy wasting/inflammation or aluminum toxicity, and fewer participants randomly assigned to ferric citrate had serious adverse events. Ferric citrate is an effective phosphate binder with a safety profile comparable to sevelamer and calcium acetate.