Akizawa Tadao, Kurita Noriaki, Mizobuchi Masahide, Fukagawa Masafumi, Onishi Yoshihiro, Yamaguchi Takuhiro, Ellis Alan R, Fukuma Shingo, Alan Brookhart M, Hasegawa Takeshi, Kurokawa Kiyoshi, Fukuhara Shunichi
Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.
Department of Innovative Research and Education for Clinicians and Trainees (DiRECT), Fukushima Medical University Hospital, Fukushima, Japan.
Sci Rep. 2016 Apr 13;6:19612. doi: 10.1038/srep19612.
Cinacalcet lowers parathyroid hormone levels. Whether it can prolong survival of people with chronic kidney disease (CKD) complicated by secondary hyperparathyroidism (SHPT) remains controversial, in part because a recent randomized trial excluded patients with iPTH <300 pg/ml. We examined cinacalcet's effects at different iPTH levels. This was a prospective case-cohort and cohort study involving 8229 patients with CKD stage 5D requiring maintenance hemodialysis who had SHPT. We studied relationships between cinacalcet initiation and important clinical outcomes. To avoid confounding by treatment selection, we used marginal structural models, adjusting for time-dependent confounders. Over a mean of 33 months, cinacalcet was more effective in patients with more severe SHPT. In patients with iPTH ≥ 500 pg/ml, the reduction in the risk of death from any cause was about 50% (Incidence Rate Ratio [IRR] = 0.49; 95% Confidence Interval [95% CI]: 0.29-0.82). For a composite of cardiovascular hospitalization and mortality, the association was not statistically significant, but the IRR was 0.67 (95% CI: 0.43-1.06). These findings indicate that decisions about using cinacalcet should take into account the severity of SHPT.
西那卡塞可降低甲状旁腺激素水平。它能否延长合并继发性甲状旁腺功能亢进（SHPT）的慢性肾脏病（CKD）患者的生存期仍存在争议，部分原因是最近一项随机试验排除了iPTH<300 pg/ml的患者。我们研究了西那卡塞在不同iPTH水平下的作用。这是一项前瞻性病例队列和队列研究，纳入了8229例需要维持性血液透析且患有SHPT的CKD 5D期患者。我们研究了开始使用西那卡塞与重要临床结局之间的关系。为避免治疗选择造成的混杂，我们使用了边际结构模型，并对随时间变化的混杂因素进行了调整。在平均33个月的时间里，西那卡塞对SHPT更严重的患者更有效。在iPTH≥500 pg/ml的患者中，任何原因导致的死亡风险降低约50%（发病率比[IRR]=0.49；95%置信区间[95%CI]：0.29-0.82）。对于心血管住院和死亡的综合情况，该关联无统计学意义，但IRR为0.67（95%CI：0.43-1.06）。这些发现表明，关于使用西那卡塞的决策应考虑SHPT的严重程度。
