Chen Wei, Liu Hua-Feng, Chen Qin-Kai, Zhao Ming-Hui, Chen Xiao-Nong, Liu Hong, Wan Jian-Xin, Li Shao-Mei, Chen Meng-Hua, Dai Chun, Shi Hong-Bin, Wei Jia-Li, Zhao Hong-Wen, Wang Li-Hua, Long Gang, Lu Wan-Hong, Tang Ying, Yang Jun-Wei, Cao Li-Ying, Tang Dong-Xing, Yang Yu-Qiong, Yu Xue-Qing
Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
Key Laboratory of Nephrology, National Health Commission and Guangdong Province, Guangzhou, China.
Kidney Dis (Basel). 2022 Dec 15;9(2):82-93. doi: 10.1159/000527833. eCollection 2023 Apr.
Previous studies suggested that sevelamer carbonate is well tolerated with a favorable efficacy and safety profile in both dialysis and nondialysis patients in Europe; however, the efficacy remains controversial, and few studies have examined sevelamer carbonate therapy in other ethnic nondialysis CKD patients. This study assessed the efficacy and safety of sevelamer carbonate in Chinese nondialysis CKD patients with hyperphosphatemia.
The multicenter, randomized, double-blind, parallel-group, placebo-controlled, and phase 3 clinical trial enrolled 202 Chinese nondialysis CKD patients with serum phosphorus ≥1.78 mmol/L. Patients were randomly assigned 1:1 to receive sevelamer carbonate (2.4-12 g per day) or placebo for 8 weeks. The primary outcome was the change in serum phosphorous between baseline and week 8.
Totally 482 Chinese patients were screened and 202 were randomized (sevelamer carbonate, = 101; placebo, = 101). The mean serum phosphorous decreased significantly in patients treated with sevelamer carbonate compared with placebo (-0.22 ± 0.47 vs. 0.05 ± 0.44 mmol/L, < 0.0001). Significantly ( < 0.0001), decreases of serum total cholesterol, low-density lipoprotein cholesterol, and calcium-phosphorus (Ca × P) product levels from baseline to week 8 were shown in sevelamer carbonate group compared with placebo group. Serum intact parathyroid hormone was not significantly changed in the sevelamer carbonate group ( = 0.83). Patients in the sevelamer carbonate group experienced similar adverse events as the placebo group.
Sevelamer carbonate is an effective and well-tolerated phosphate binder in advanced nondialysis CKD Chinese patients with hyperphosphatemia.
先前的研究表明，在欧洲，碳酸司维拉姆在透析和非透析患者中耐受性良好，疗效和安全性良好；然而，其疗效仍存在争议，很少有研究在其他种族的非透析慢性肾脏病（CKD）患者中检验碳酸司维拉姆治疗效果。本研究评估了碳酸司维拉姆在中国非透析CKD高磷血症患者中的疗效和安全性。
这项多中心、随机、双盲、平行组、安慰剂对照的3期临床试验纳入了202例血清磷≥1.78 mmol/L的中国非透析CKD患者。患者按1:1随机分配，接受碳酸司维拉姆（每日2.4 - 12 g）或安慰剂治疗8周。主要结局是基线至第8周血清磷的变化。
共筛查了482例中国患者，202例被随机分组（碳酸司维拉姆组 = 101例；安慰剂组 = 101例）。与安慰剂组相比，接受碳酸司维拉姆治疗的患者平均血清磷显著降低（-0.22±0.47 vs. 0.05±0.44 mmol/L，P<0.0001）。与安慰剂组相比，碳酸司维拉姆组从基线至第8周血清总胆固醇、低密度脂蛋白胆固醇和钙磷（Ca×P）乘积水平显著降低（P<0.0001）。碳酸司维拉姆组血清完整甲状旁腺激素无显著变化（P = 0.83）。碳酸司维拉姆组患者发生的不良事件与安慰剂组相似。
碳酸司维拉姆在晚期非透析CKD中国高磷血症患者中是一种有效且耐受性良好的磷结合剂。
