Zitt Emanuel, Fouque Denis, Jacobson Stefan H, Malberti Fabio, Ryba Miroslav, Ureña Pablo, Rix Marianne, Dehmel Bastian, Manamley Nick, Vervloet Marc
Academic Teaching Hospital , Feldkirch , Austria.
Clin Kidney J. 2013 Jun;6(3):287-294. doi: 10.1093/ckj/sft026. Epub 2013 Apr 11.
The calcimimetic cinacalcet lowers parathyroid hormone (PTH), calcium (Ca) and phosphorus (P) in dialysis patients with secondary hyperparathyroidism (SHPT). We explored serum P changes in dialysis patients treated with cinacalcet, while controlling for vitamin D sterol and phosphate binder (PB) changes, based on data from the pan-European observational study ECHO.
Patients were categorized by serum P change (decreased/unchanged/increased) at 12 months after starting cinacalcet and subcategorized by vitamin D sterol and PB dose changes (decreased/unchanged/increased). The impact of PTH, Ca and P, and vitamin D sterol, PB and cinacalcet doses (absolute values and/or change) was evaluated. Predictors of P change were explored using univariate and multivariate general linear models (GLM) and logistic regression analysis.
At Month 12, 661 (41%) of 1607 patients had decreased, 61 (4%) unchanged and 400 (25%) increased serum P, while 485 patients had missing data. In 45% of the patients with serum P reduction, vitamin D was either increased or unchanged and P binders decreased or unchanged. PTH was a key predictor of serum P reduction, with an estimated 3% decrease in P per 10% reduction in PTH. Changes in vitamin D sterol and PB doses were not generally significant factors in GLM and regression analyses.
The serum P reduction observed in a significant proportion of dialysis patients after adding cinacalcet to an existing therapeutic regimen for SHPT appears to result mainly from PTH reduction, rather than from changes in vitamin D sterol or PB doses. Financial support for the ECHO study was provided by Amgen.
拟钙剂西那卡塞可降低继发性甲状旁腺功能亢进(SHPT)透析患者的甲状旁腺激素(PTH)、钙(Ca)和磷(P)水平。基于泛欧洲观察性研究ECHO的数据,我们在控制维生素D固醇和磷结合剂(PB)变化的同时,探讨了接受西那卡塞治疗的透析患者的血清磷变化情况。
根据开始使用西那卡塞12个月后的血清磷变化(降低/不变/升高)对患者进行分类,并根据维生素D固醇和PB剂量变化(降低/不变/升高)进行亚分类。评估PTH、Ca、P以及维生素D固醇、PB和西那卡塞剂量(绝对值和/或变化)的影响。使用单变量和多变量一般线性模型(GLM)以及逻辑回归分析来探索磷变化的预测因素。
在第12个月时,1607例患者中有661例(41%)血清磷降低,61例(4%)不变,400例(25%)升高,另有485例患者数据缺失。在血清磷降低的患者中,45%的患者维生素D水平升高或不变,磷结合剂减少或不变。PTH是血清磷降低的关键预测因素,PTH每降低10%,磷估计降低3%。在GLM和回归分析中,维生素D固醇和PB剂量的变化通常不是显著因素。
在现有SHPT治疗方案中加用西那卡塞后,相当一部分透析患者出现血清磷降低,这似乎主要是由于PTH降低,而非维生素D固醇或PB剂量的变化。ECHO研究得到了安进公司的资金支持。