Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis
Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis
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DOI：
10.1056/nejmoa031633
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发表时间：
2004-04-08
影响因子：
158.5
通讯作者：
Goodman, WG
中科院分区：
文献类型：
--
作者：
Block, GA;Martin, KJ;Goodman, WG
背景：在接受透析的患者中，用维生素D和钙治疗继发性甲状旁腺功能亢进常并发高钙血症和高磷血症，这可能导致心血管疾病和不良的临床结果。石灰化剂靶向钙敏感受体和降低甲状旁腺激素水平，而不增加钙和磷水平。我们报告了两项相同的随机、双盲、安慰剂对照试验的结果，评估了拟钙化剂盐酸西那卡塞的安全性和有效性。方法：接受血液透析和经标准治疗后继发性甲状旁腺功能亢进控制不充分的患者被随机分配接受cinacalcet（371例）或安慰剂（370例）26周。每日一次的剂量从30毫克增加到180毫克，以达到每毫升250毫克或更低的甲状旁腺激素水平。主要终点是在14周的疗效评估阶段中值在该范围内的患者百分比。结果：cinacalcet组有43%的患者达到了主要终点，而安慰剂组只有5% (P
BACKGROUND:Treatment of secondary hyperparathyroidism with vitamin D and calcium in patients receiving dialysis is often complicated by hypercalcemia and hyperphosphatemia, which may contribute to cardiovascular disease and adverse clinical outcomes. Calcimimetics target the calcium-sensing receptor and lower parathyroid hormone levels without increasing calcium and phosphorus levels. We report the results of two identical randomized, double-blind, placebo-controlled trials evaluating the safety and effectiveness of the calcimimetic agent cinacalcet hydrochloride.METHODS:Patients who were receiving hemodialysis and who had inadequately controlled secondary hyperparathyroidism despite standard treatment were randomly assigned to receive cinacalcet (371 patients) or placebo (370 patients) for 26 weeks. Once-daily doses were increased from 30 mg to 180 mg to achieve intact parathyroid hormone levels of 250 pg per milliliter or less. The primary end point was the percentage of patients with values in this range during a 14-week efficacy-assessment phase.RESULTS:Forty-three percent of the cinacalcet group reached the primary end point, as compared with 5 percent of the placebo group (P