Akizawa Tadao, Origasa Hideki, Kameoka Chisato, Kaneko Yuichiro, Kawasaki Shigenori
Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.
Ther Apher Dial. 2014 Apr;18(2):122-31. doi: 10.1111/1744-9987.12068. Epub 2013 Aug 27.
Hyperphosphatemia is a prognostic factor for morbidity and mortality in chronic kidney disease. Bixalomer is a nonabsorbable polymer that decreases serum phosphate levels by binding phosphate in the gastrointestinal tract. This study compared the efficacy and safety of bixalomer versus sevelamer hydrochloride for controlling hyperphosphatemia in hemodialysis patients. This was a multicenter, randomized open-label, non-inferiority study. The primary endpoint was serum phosphate on completion of treatment. Administration of bixalomer was started at 1.5 g/day and adjusted to a maximum of 7.5 g/day depending on the serum phosphate level. Sevelamer hydrochloride was started at 3.0 or 6.0 g/day and adjusted to a maximum of 9.0 g/day. Treatment was continued for 12 weeks. Fifty-five patients were randomized to each treatment group. After 12 weeks, the baseline adjusted mean serum phosphate level was 5.87 mg/dL in the bixalomer group and 5.55 mg/dL in the sevelamer group, with a difference of 0.31 mg/dL and 95% confidence interval (CI) of [-0.13 to 0.76]. The upper limit of the 95%CI for the difference of the mean serum phosphate level between the two groups was <1.0 mg/dL, which was the non-inferiority margin in this study. Thus, non-inferiority of bixalomer to sevelamer was confirmed. The incidence of adverse events was lower in the bixalomer group, and bixalomer did not promote acidosis. Bixalomer achieved a similar reduction of serum phosphate to sevelamer, while causing fewer adverse reactions. Consequently, the usefulness of bixalomer for treating hyperphosphatemia was confirmed.
高磷血症是慢性肾脏病发病和死亡的一个预后因素。比沙洛美是一种不可吸收的聚合物，通过在胃肠道结合磷酸盐来降低血清磷酸盐水平。本研究比较了比沙洛美与盐酸司维拉姆在控制血液透析患者高磷血症方面的疗效和安全性。这是一项多中心、随机开放标签、非劣效性研究。主要终点是治疗结束时的血清磷酸盐水平。比沙洛美起始剂量为1.5克/天，并根据血清磷酸盐水平调整至最大7.5克/天。盐酸司维拉姆起始剂量为3.0或6.0克/天，并调整至最大9.0克/天。治疗持续12周。每个治疗组随机分配55例患者。12周后，比沙洛美组基线调整后的平均血清磷酸盐水平为5.87毫克/分升，司维拉姆组为5.55毫克/分升，差异为0.31毫克/分升，95%置信区间（CI）为[-0.13至0.76]。两组平均血清磷酸盐水平差异的95%CI上限<1.0毫克/分升，这是本研究中的非劣效界值。因此，证实了比沙洛美不劣于司维拉姆。比沙洛美组不良事件的发生率较低，且比沙洛美不会促进酸中毒。比沙洛美降低血清磷酸盐的效果与司维拉姆相似，同时不良反应较少。因此，证实了比沙洛美治疗高磷血症的有效性。
