Home Dialysis Center (HDC), Center of Study for Social and Health Humaniztion (CEHUS), São Paulo, Brazil.
Department of Pharmacology, Institute of Biomedical Sciences, University of São Paulo, Brazil.
Int J Immunopathol Pharmacol. 2014 Jan-Mar;27(1):25-35. doi: 10.1177/039463201402700105.
Sevelamer hydrochloride is an ionic exchange resin with high affinity for phosphate. This phosphate-binding agent has few serious adverse reactions with the advantage of reducing total and low density lipoprotein (LDL) cholesterol levels. However, it is controversial as to whether sevelamer hydrochloride can modulate the inflammatory response via endotoxin reduction. Therefore, a single-center, open-label, prospective and randomized study was performed to compare the clinical efficacy, safety and anti-inflammatory activity of two sevelamer hydrochloride tablet forms a branded tablet form, Renagel (Genzyme manufacturer) and its generic equivalent (EMS manufacturer). Twenty-eight chronic kidney disease volunteer patients at stage 5 (CDK 5D), on chronic low-flux hemodialysis carried out in 4-hour sessions, three times a week, were studied. The serum phosphorus, ionic calcium, total cholesterol and fractions, bicarbonate, blood pH, interleukin (IL)-6, IL-10, IL-1 beta and tumor necrosis factor-alpha (TNF-alpha) levels were collected prior to dialysis at mid-week. The incidence of gastrointestinal adverse effects were determined at the end of the phosphate-binder washout period as well as at the end of the fourth and eighth weeks of use of both tablet forms. The same magnitude of reduction in serum phosphorus was observed with both sevelamer tablet forms. Only the Renagel group showed lower total cholesterol and lower LDL cholesterol levels at the fourth and eighth week versus baseline. No significant differences in serum cytokine levels were identified in either drug group. However, the incidence of intestinal obstipation was higher among patients who used the generic equivalent form. In conclusion, Renagel and its EMS generic equivalent tablet forms have a similar clinical efficacy in reducing phosphorus in CKD 5D patients on low-flux hemodialysis and a similar safety profile.
盐酸司维拉姆是一种对磷酸盐具有高亲和力的离子交换树脂。这种磷酸盐结合剂的严重不良反应较少，其优点是降低总胆固醇和低密度脂蛋白（LDL）胆固醇水平。然而，关于盐酸司维拉姆是否可以通过降低内毒素来调节炎症反应仍存在争议。因此，进行了一项单中心、开放标签、前瞻性和随机研究，比较了两种盐酸司维拉姆片剂的临床疗效、安全性和抗炎活性，一种是品牌片剂瑞格（Genzyme 制造商），另一种是其通用等效制剂（EMS 制造商）。研究了 28 名处于 5 期（CKD 5D）的慢性肾病志愿者患者，他们接受每周 3 次、每次 4 小时的低通量慢性血液透析。在透析前的周中、透析结束时和使用两种片剂的第 4 周和第 8 周收集血清磷、离子钙、总胆固醇和各部分、碳酸氢盐、血液 pH 值、白细胞介素（IL）-6、IL-10、IL-1β和肿瘤坏死因子-α（TNF-α）水平。在磷酸盐结合剂洗脱期结束时以及使用两种片剂的第 4 周和第 8 周结束时，确定胃肠道不良反应的发生率。两种司维拉姆片剂形式都观察到血清磷的同等程度降低。只有瑞格组在第 4 周和第 8 周时总胆固醇和 LDL 胆固醇水平较基线更低。在任何药物组中，血清细胞因子水平均无显著差异。然而，使用通用等效制剂的患者中肠道便秘的发生率更高。总之，瑞格及其 EMS 通用等效片剂形式在降低低通量血液透析的 CKD 5D 患者的磷方面具有相似的临床疗效和安全性。
