拟钙剂AMG 073可降低继发性甲状旁腺功能亢进症患者的甲状旁腺激素水平及钙磷乘积。
The calcimimetic AMG 073 reduces parathyroid hormone and calcium x phosphorus in secondary hyperparathyroidism.
作者信息
Lindberg Jill S, Moe Sharon M, Goodman William G, Coburn Jack W, Sprague Stuart M, Liu Wei, Blaisdell Peter W, Brenner Robert M, Turner Stewart A, Martin Kevin J
机构信息
Ochsner Clinical Research Center, New Orleans, Louisiana 70121, USA.
出版信息
Kidney Int. 2003 Jan;63(1):248-54. doi: 10.1046/j.1523-1755.2003.00720.x.
BACKGROUND
A need exists for a therapy that lowers parathyroid hormone (PTH) without increasing calcium x phosphorus in patients with secondary hyperparathyroidism. The calcimimetic AMG 073 increases the sensitivity of the parathyroid calcium-sensing receptor to extracellular calcium, thereby reducing PTH secretion. Consequently, AMG 073 may provide a novel therapy for secondary hyperparathyroidism.
METHODS
Seventy-eight hemodialysis patients with secondary hyperparathyroidism were enrolled into this 18-week, double-blind, randomized, placebo-controlled, dose titration study. Daily oral AMG 073 doses were administered to determine the effect on PTH, serum calcium, phosphorus, and calcium x phosphorus.
RESULTS
The mean baseline PTH was similar in patients administered AMG 073 or placebo (632 +/- 280.1 pg/mL vs. 637 +/- 455.9 pg/mL, respectively). PTH decreased by 26.0% in the AMG 073-treated group, compared with an increase of 22.0% in the placebo group (P < 0.001). A greater proportion in the AMG 073 group (38%) had a decrease in PTH >or=30%, compared with the placebo group (8%) (P = 0.001). Decreases in PTH were independent of baseline vitamin D usage. Patients receiving AMG 073 had an 11.9% decrease in calcium x phosphorus compared with a 10.9% increase in the placebo group (P < 0.001). Use of vitamin D sterols, as well as both calcium and noncalcium-containing phosphate binders. were similar between treatment groups. Administration of AMG 073 was safe and well tolerated in this 18-week study.
CONCLUSIONS
The calcimimetic AMG 073 decreases both PTH and calcium x phosphorus levels in hemodialysis patients with secondary hyperparathyroidism.
背景
对于继发性甲状旁腺功能亢进患者，需要一种在不增加钙磷乘积的情况下降低甲状旁腺激素（PTH）的治疗方法。拟钙剂AMG 073可增加甲状旁腺钙敏感受体对细胞外钙的敏感性，从而减少PTH分泌。因此，AMG 073可能为继发性甲状旁腺功能亢进提供一种新的治疗方法。
方法
78例继发性甲状旁腺功能亢进的血液透析患者被纳入这项为期18周的双盲、随机、安慰剂对照、剂量滴定研究。给予每日口服AMG 073剂量，以确定其对PTH、血清钙、磷和钙磷乘积的影响。
结果
接受AMG 073或安慰剂治疗的患者平均基线PTH相似（分别为632±280.1 pg/mL和637±455.9 pg/mL）。AMG 073治疗组的PTH下降了26.0%，而安慰剂组增加了22.0%（P<0.001）。AMG 073组中PTH下降≥30%的比例更高（38%），而安慰剂组为8%（P = 0.001）。PTH的下降与基线维生素D的使用无关。接受AMG 073治疗的患者钙磷乘积下降了11.9%，而安慰剂组增加了10.9%（P<0.001）。治疗组之间维生素D甾醇以及含钙和不含钙的磷结合剂的使用情况相似。在这项为期18周的研究中，AMG 073的给药是安全且耐受性良好的。
结论
拟钙剂AMG 073可降低继发性甲状旁腺功能亢进血液透析患者的PTH和钙磷乘积水平。
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