Shigematsu Takashi
Division of Nephrology and Blood Purification Medicine, Wakayama Medical University, Wakayama, Japan.
Ther Apher Dial. 2008 Feb;12(1):55-61. doi: 10.1111/j.1744-9987.2007.00541.x.
Treating hyperphosphatemia without increasing the calcium load in chronic kidney disease patients on dialysis is important, as conventional treatment frequently results in ectopic calcification. Sevelamer, a monotherapy for hyperphosphatemia is frequently associated with gastrointestinal disorders, often resulting in discontinuation of treatment. Lanthanum carbonate is a novel non-calcium-based phosphate binder for the treatment of chronic kidney disease. Here, its clinical efficacy and safety were assessed in Japanese dialysis patients. A placebo-controlled, randomized, double-blind, parallel group, multicenter study was performed in Japanese dialysis patients. Patients were treated with various dosages of lanthanum carbonate or a placebo daily for six weeks. The primary efficacy endpoint was the change in serum phosphate level from the baseline. Secondary endpoints included achievement rates to target serum phosphate levels and changes in serum calcium levels. Safety was evaluated by the incidence of drug-related and treatment-emergent adverse events. A significant reduction in serum phosphate level was demonstrated for all dosages from Week 1. This dose-dependent effect was also observed in the changes in serum calcium x phosphate product, yet there was no notable difference in serum calcium or serum intact parathyroid hormone levels. The incidence of drug-related adverse events was dose-dependent, with the most common being gastrointestinal symptoms. Lanthanum carbonate effectively controls serum phosphate levels and is generally tolerable to Japanese chronic kidney disease patients on dialysis, as reported for the Caucasian population. The optimal dosage in Japanese patients needs to be confirmed using a flexible-dose titration schedule.
在接受透析的慢性肾脏病患者中,在不增加钙负荷的情况下治疗高磷血症很重要,因为传统治疗常常导致异位钙化。司维拉姆作为一种治疗高磷血症的单一疗法,常与胃肠道疾病相关,常常导致治疗中断。碳酸镧是一种用于治疗慢性肾脏病的新型非钙基磷酸盐结合剂。在此,对日本透析患者评估了其临床疗效和安全性。在日本透析患者中开展了一项安慰剂对照、随机、双盲、平行组、多中心研究。患者每天接受不同剂量的碳酸镧或安慰剂治疗,为期六周。主要疗效终点是血清磷酸盐水平相对于基线的变化。次要终点包括达到目标血清磷酸盐水平的成功率和血清钙水平的变化。通过药物相关和治疗中出现的不良事件的发生率评估安全性。从第1周起,所有剂量的血清磷酸盐水平均显著降低。在血清钙×磷酸盐乘积的变化中也观察到这种剂量依赖性效应,但血清钙或血清完整甲状旁腺激素水平没有显著差异。药物相关不良事件的发生率呈剂量依赖性,最常见的是胃肠道症状。正如在白种人群中所报道的那样,碳酸镧能有效控制血清磷酸盐水平,并且日本接受透析的慢性肾脏病患者总体上可以耐受。需要采用灵活的剂量滴定方案来确定日本患者的最佳剂量。