Paricalcitol versus cinacalcet plus low-dose vitamin D for the treatment of secondary hyperparathyroidism in patients receiving haemodialysis: study design and baseline characteristics of the IMPACT SHPT study.
Paricalcitol versus cinacalcet plus low-dose vitamin D for the treatment of secondary hyperparathyroidism in patients receiving haemodialysis: study design and baseline characteristics of the IMPACT SHPT study.
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DOI：
10.1093/ndt/gfr531
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发表时间：
2012-05
期刊：
影响因子：
--
通讯作者：
Audhya P
中科院分区：
文献类型：
--
作者：
Ketteler M;Martin KJ;Cozzolino M;Goldsmith D;Sharma A;Khan S;Dumas E;Amdahl M;Marx S;Audhya P
背景帕立骨化醇和西那卡塞是继发性甲状旁腺功能亢进（SHPT）血液透析患者的常用疗法。我们在12个国家进行了一项多中心研究，以比较帕立骨化醇和西那卡塞治疗SHPT的安全性和疗效。 方法.年龄≥18岁、接受维持性血液透析且全段甲状旁腺激素（iPTH）300-800 pg/mL的5期慢性肾病患者，钙8.4-10.0 mg/dL（2.09-2.49 mmol/L）和磷≤6.5 mg/dL（2.09 mmol/L）被随机分配到根据帕立骨化醇给药模式定义的两个分层中，（静脉内，美国和俄罗斯部位，IV层;口服，非美国和非俄罗斯部位，口服层）或西那卡塞为中心的治疗。主要终点是每个治疗组中在治疗第21-28周期间达到平均iPTH值150-300 pg/mL的患者比例。假设西那卡塞和帕立骨化醇的疗效缓解率分别为36%和66%，停药率为20%，估计每个分层中的124例受试者可提供81%的把握度来检测主要终点的30%绝对差异。 结果在筛选的746例患者中，272例（平均年龄：63岁;平均iPTH：509 pg/mL）接受了随机化。基线时血液透析的平均持续时间为3.7年。合并症包括高血压（90.4%）、2型糖尿病（40.4%）、充血性心力衰竭（17.3%）、冠状动脉疾病（34.6%）和胃肠道疾病（75%）。 结论.研究参与者代表了iPTH升高的血液透析患者的多国队列。研究结果将为血液透析患者的SHPT最佳治疗提供有价值的信息。
Background. Paricalcitol and cinacalcet are common therapies for patients on haemodialysis with secondary hyperparathyroidism (SHPT). We conducted a multi-centre study in 12 countries to compare the safety and efficacy of paricalcitol and cinacalcet for the treatment of SHPT. Methods. Patients aged ≥18 years with Stage 5 chronic kidney disease receiving maintenance haemodialysis and with intact parathyroid hormone (iPTH) 300–800 pg/mL, calcium 8.4–10.0 mg/dL (2.09–2.49 mmol/L) and phosphorus ≤6.5 mg/dL (2.09 mmol/L) were randomized within two strata defined by the mode of paricalcitol administration to treatment with paricalcitol- (intra-venous, US and Russian sites, IV stratum; oral, non-US and non-Russian sites, oral stratum) or cinacalcet-centred therapy. The primary endpoint is the proportion of patients in each treatment group who achieve a mean iPTH value of 150–300 pg/mL during Weeks 21–28 of treatment. Assuming efficacy response rates of 36 and 66% for cinacalcet and paricalcitol, respectively, and a 20% discontinuation rate, 124 subjects in each stratum were estimated to provide 81% power to detect a 30% absolute difference in the primary endpoint. Results. Of 746 patients screened, 272 (mean age, 63 years; mean iPTH, 509 pg/mL) were randomized. Mean duration of haemodialysis at baseline was 3.7 years. Comorbidities included hypertension (90.4%), Type 2 diabetes (40.4%), congestive heart failure (17.3%), coronary artery disease (34.6%) and gastrointestinal disorders (75%). Conclusions. The study participants are representative of a multinational cohort of patients on haemodialysis with elevated iPTH. The study results will provide valuable information on the best available treatment of SHPT in patients on haemodialysis.
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DOI：
10.1056/nejmoa0706130
发表时间：
2008-08-07
期刊：
The New England journal of medicine
影响因子：
--
作者：
Gutiérrez OM;Mannstadt M;Isakova T;Rauh-Hain JA;Tamez H;Shah A;Smith K;Lee H;Thadhani R;Jüppner H;Wolf M
通讯作者：
Wolf M
影响因子：
19.6
作者：
Galitzer, H.;Ben-Dov, I. Z.;Naveh-Many, Tally
通讯作者：
Naveh-Many, Tally
影响因子：
19.6
作者：
Block, Geoffrey A.;Zaun, David;St Peter, Wendy L.
通讯作者：
St Peter, Wendy L.
影响因子：
4.2
作者：
Lund, Richard J.;Andress, Dennis L.;Heaney, Robert P.
通讯作者：
Heaney, Robert P.
影响因子：
158.5
作者：
Block, GA;Martin, KJ;Goodman, WG
通讯作者：
Goodman, WG