Cinacalcet Lowers Serum Alkaline Phosphatase in Maintenance Hemodialysis Patients
Cinacalcet Lowers Serum Alkaline Phosphatase in Maintenance Hemodialysis Patients
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DOI：
10.2215/cjn.03790808
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发表时间：
2009-03-01
影响因子：
9.8
通讯作者：
Kalantar-Zadeh, Kamyar
中科院分区：
文献类型：
--
作者：
Belozeroff, Vasily;Goodman, William G.;Kalantar-Zadeh, Kamyar
背景和目标：研究表明血清碱性磷酸酶（AP）升高与血液透析患者死亡率增加之间存在相关性，但现有治疗对AP的影响尚未完全了解。我们评估了西那卡塞对AP的影响，在控制试验data.Design的二次分析，设置，参与者和测量：这是一个事后分析的数据从三个26周的随机，双盲，安慰剂对照，3期试验和26周的双盲，安慰剂对照的扩展试验，调查西那卡塞在继发性甲状旁腺功能亢进治疗透析患者。对890例甲状旁腺素>= 300 pg/ml、血钙>= 8.4 mg/dl的血液透析患者，采用西那卡塞加标准治疗或单用标准治疗52 wk。评估了总AP（非骨特异性AP）在基线;滴定结束;以及研究第26、42和52周时（西那卡塞/对照受试者实现AP自基线降低>= 20%或任何AP降低的比例; AP >= 120 U/L的受试者比例）。在52周时，与对照组相比，西那卡塞治疗组AP降低≥ 20%（39 vs 18%）或任何AP降低（58 vs 36%）的患者比例更高。在第52周，达到≥ 20%或任何AP降低（由相对比例确定）的可能性分别为2.33（95%置信区间1.50至3.61）和1.74（95%置信区间1.31至2.31）。与对照组（分别为35.0 - 48.6%）相比，西那卡塞治疗倾向于降低AP >= 120 U/L的患者百分比（基线，42.6%;第52周，30.6%）。
Background and objectives: Studies suggest an association between elevated serum alkaline phosphatase (AP) and increased mortality in hemodialysis patients, but the effect of existing therapies on AP is not fully understood. We assessed the effects of cinacalcet on AP in a secondary analysis of controlled trial data.Design, setting, participants, & measurements: This was a post hoc analysis of data from three 26-wk randomized, double-blind, placebo-controlled, phase 3 trials and a 26-wk double-blind, placebo-controlled extension trial that investigated cinacalcet in secondary hyperparathyroidism treatment in dialysis patients. Hemodialysis patients (n = 890) with intact parathyroid hormone >= 300 pg/ml and serum calcium >= 8.4 mg/dl received cinacalcet plus standard therapy or standard therapy alone for up to 52 wk. Total, not bone-specific, AP was assessed (proportion of cinacalcet/control subjects achieving a >= 20% or any AP reduction from baseline; the proportion of subjects with AP >= 120 U/L) at baseline; the end of titration; and study weeks 26, 42, and 52.Results: At 52 wk, a greater proportion of cinacalcet-treated patients had either a >= 20% (39 versus 18%) or any (58 versus 36%) AP reduction compared with control subjects, respectively. The likelihood of achieving either a >= 20% or any AP reduction (determined by relative proportion) was 2.33 (95% confidence interval 1.50 to 3.61) and 1.74 (95% confidence interval 1.31 to 2.31), respectively, at week 52. Cinacalcet treatment tended toward a decreased percentage of patients with AP >= 120 U/L (baseline, 42.6%; week 52, 30.6%) compared with control (35.0 to 48.6%, respectively).Conclusions: In this combined analysis of controlled trials of patients who were receiving hemodialysis, cinacalcet lowered total serum AP.