Division of Nephrology, Klinikum Coburg, Coburg, Germany.
Nephrol Dial Transplant. 2012 Aug;27(8):3270-8. doi: 10.1093/ndt/gfs018. Epub 2012 Mar 2.
Optimal treatment for secondary hyperparathyroidism (SHPT) has not been defined. The IMPACT SHPT (ClinicalTrials.gov identifier: NCT00977080) study assessed whether dose-titrated paricalcitol plus supplemental cinacalcet only for hypercalcaemia is superior to cinacalcet plus low-dose vitamin D in controlling intact parathyroid hormone (iPTH) levels in patients with SHPT on haemodialysis.
In this 28-week, multicentre, open-label Phase 4 study, participants were randomly selected to receive paricalcitol or cinacalcet plus low-dose vitamin D. Randomization and analyses were stratified by mode of paricalcitol administration [intravenous (IV) or oral]. The primary efficacy end point was the proportion of subjects who achieved a mean iPTH value of 150-300 pg/mL during Weeks 21-28.
Of 272 subjects randomized, 268 received one or more dose of study drug; 101 in the IV and 110 in the oral stratum with two or more values during Weeks 21-28 were included in the primary analysis. In the IV stratum, 57.7% of subjects in the paricalcitol versus 32.7% in the cinacalcet group (P = 0.016) achieved the primary end point. In the oral stratum, the corresponding proportions of subjects were 54.4% for paricalcitol and 43.4% for cinacalcet (P = 0.260). Cochran-Mantel-Haenszel analysis, controlling for stratum, revealed overall superiority of paricalcitol (56.0%) over cinacalcet (38.2%; P = 0.010) in achieving iPTH 150-300 pg/mL during Weeks 21-28. Hypercalcaemia occurred in 4 (7.7%) and 0 (0%) of paricalcitol-treated subjects in the IV and oral strata, respectively. Hypocalcaemia occurred in 46.9% and 54.7% of cinacalcet-treated subjects in the IV and oral strata, respectively.
Paricalcitol versus cinacalcet plus low-dose vitamin D provided superior control of iPTH, with low incidence of hypercalcaemia.
尚未明确继发性甲状旁腺功能亢进症（SHPT）的最佳治疗方法。IMPACT SHPT（ClinicalTrials.gov 标识符：NCT00977080）研究评估了剂量滴定的帕立骨化醇加补充西那卡塞仅用于高钙血症是否优于西那卡塞加低剂量维生素 D，以控制血液透析患者的 SHPT 患者的全段甲状旁腺激素（iPTH）水平。
在这项 28 周、多中心、开放性 4 期研究中，参与者被随机选择接受帕立骨化醇或西那卡塞加低剂量维生素 D。随机化和分析按帕立骨化醇给药方式（静脉内[IV]或口服）分层。主要疗效终点是在第 21-28 周期间达到 iPTH 值 150-300 pg/mL 的受试者比例。
在 272 名随机分配的受试者中，268 名接受了一种或多种研究药物剂量；在第 21-28 周期间有两个或更多值的 101 名 IV 组和 110 名口服组被纳入主要分析。在 IV 组中，帕立骨化醇组的 57.7%的受试者与西那卡塞组的 32.7%（P = 0.016）达到了主要终点。在口服组中，帕立骨化醇组和西那卡塞组的相应比例分别为 54.4%和 43.4%（P = 0.260）。控制分层后，Cochran-Mantel-Haenszel 分析显示帕立骨化醇（56.0%）总体优于西那卡塞（38.2%；P = 0.010），在第 21-28 周期间达到 iPTH 150-300 pg/mL。IV 组和口服组分别有 4（7.7%）和 0（0%）名帕立骨化醇治疗的受试者发生高钙血症。IV 组和口服组分别有 46.9%和 54.7%的西那卡塞治疗的受试者发生低钙血症。
帕立骨化醇与西那卡塞加低剂量维生素 D 相比，可更好地控制 iPTH，且低钙血症发生率较低。
