Center for Observational Research, Amgen Inc., Thousand Oaks, CA, USA.
Am J Nephrol. 2013;37(4):389-98. doi: 10.1159/000350213. Epub 2013 Mar 29.
BACKGROUND/AIMS: Data describing real-world use and effectiveness of cinacalcet are limited. We aimed to characterize predictors of treatment and changes in secondary hyperparathyroidism (SHPT) biochemistry after cinacalcet initiation.
We studied 25,250 in-center hemodialysis patients from a large dialysis provider, alive through November 2004, with no prior cinacalcet prescription. Patients were followed until initiation of cinacalcet, censoring, death, or July 31, 2007. Initiators were further followed for dose titration and discontinuation. Predictors of these events were evaluated using Cox proportional hazards modeling. Biochemical parameters and other SHPT medication use were compared between baseline, pre-initiation, and post-initiation time points.
Over an average of 1.25 years of follow-up, 30% of patients initiated cinacalcet therapy. Between baseline and initiation (mean of 386 days), parathyroid hormone (PTH) and phosphorus levels increased 78 and 7%, respectively, in these patients. After adjustment, cinacalcet initiation was associated with higher SHPT severity, younger age, African-American race, higher phosphorus levels, and more comorbidity. Within 1 month of initiation, median PTH was reduced by 15-30% and phosphorus by 3-5%. Reductions were sustained or increased over 12 months, depending on initiating PTH level and whether dose up-titration occurred. Discontinuation was common, although many patients reinitiated.
A substantial proportion of patients experienced SHPT progression and initiated cinacalcet treatment. Reductions in biochemistry varied by disease severity and whether doses were titrated.
背景/目的：关于西那卡塞的实际应用和疗效的数据有限。本研究旨在描述西那卡塞治疗开始后甲状旁腺功能亢进症（SHPT）生化指标变化的预测因素。
我们研究了一家大型透析机构的 25250 名中心血液透析患者，这些患者在 2004 年 11 月前均无西那卡塞用药史。患者在开始使用西那卡塞、被剔除、死亡或 2007 年 7 月 31 日前接受随访。开始使用西那卡塞的患者进一步接受剂量调整和停药随访。采用 Cox 比例风险模型评估这些事件的预测因素。在基线、用药前和用药后时间点比较生化参数和其他治疗 SHPT 的药物使用情况。
在平均 1.25 年的随访期间，30%的患者开始使用西那卡塞治疗。与基线相比，在开始治疗前（平均 386 天），患者甲状旁腺激素（PTH）和磷水平分别增加了 78%和 7%。校正后，开始使用西那卡塞与更严重的 SHPT、年龄更小、非裔美国人、更高的磷水平和更多的合并症相关。在开始治疗后 1 个月内，PTH 中位数降低 15%-30%，磷降低 3%-5%。在 12 个月内，降低或升高的幅度取决于开始时的 PTH 水平和是否调整剂量。虽然许多患者重新开始使用西那卡塞，但停药的情况较为常见。
相当一部分患者的甲状旁腺功能亢进症病情进展并开始使用西那卡塞治疗。生化指标的降低程度取决于疾病的严重程度和剂量是否调整。
