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学科主题: 临床医学
题名:
Efficacy and initial dose determination of paricalcitol for treatment of secondary hyperparathyroidism in Chinese subjects
作者: Yan, Yucheng1; Qian, Jiaqi1; Chen, Nan2; Huang, Zhaoxing3; Jiang, Gengru4; Li, Xuewang5; Lin, Hongli6; Liu, Liqiu7; Wang, Mei8; Xing, Changying9,10; Yu, Xueqing11; Zuo, Li12; Amdahl, Michael13; Khan, Samina13
关键词: paricalcitol ; secondary hyperparathyroidism ; end-stage renal disease ; hemodialysis
刊名: CLINICAL NEPHROLOGY
发表日期: 2014
DOI: 10.5414/CN107762
卷: 81, 期:1, 页:20-29
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Urology & Nephrology
研究领域[WOS]: Urology & Nephrology
关键词[WOS]: CHRONIC KIDNEY-DISEASE ; VITAMIN-D ; ALKALINE-PHOSPHATASE ; SERUM-CALCIUM ; BONE-DISEASE ; HEMODIALYSIS ; CALCITRIOL ; MORTALITY ; SURVIVAL ; CKD
英文摘要:

Aim: Prevalence of secondary hyperparathyroidism (SHPT), a renal disease complication, is increasing in China. Available therapies may not optimally control SHPT, particularly in patients with hypercalcemia, hyperphosphatemia, and parathyroid hyperplasia. This study examined efficacy and safety of two dosing regimens of selective vitamin D receptor activator paricalcitol. Materials and methods: Subjects with SHPT (n = 216) undergoing hemodialysis were treated with paricalcitol IV for 12 weeks. One group was treated according to the EU paricalcitol package insert (PI) (initial mu g dose based on iPTH/80), and the other was treated according to the US PI (initial dose of 0.04 mu g/kg). Dose titration was based on iPTH and serum calcium (Ca) and phosphorus (P) levels. Results: The primary endpoint of two consecutive >= 30% iPTH decreases was achieved by 88.6% and 55.9% of subjects in the EU and US PI groups, respectively. Noninferiority of the EU PI group vs. the US PI group was demonstrated (lower bound of the 1-sided 97.5% CI = 21.3%). Superiority of the EU PI group was shown (lower limit > 0%) and confirmed by Fisher′s exact-test (p < 0.001); both groups showed similar achievement of recommended KDIGO iPTH levels. Ca and P levels were relatively constant. Conclusion: Both EU and US PI paricalcitol dosing strategies effectively reduced iPTH levels in Chinese subjects with SHPT, with minimal impact on Ca and P levels.

语种: 英语
项目资助者: AbbVie Inc. ; AbbVie
WOS记录号: WOS:000335444800003
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/55820
Appears in Collections:北京大学第二临床医学院_期刊论文

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作者单位: 1.AbbVie Inc, N Chicago, IL USA
2.Peking Univ, Peoples Hosp, Beijing 100871, Peoples R China
3.Jiangsu Prov Hosp, Nanjing, Jiangsu, Peoples R China
4.Peking Univ, Hosp 1, Beijing 100871, Peoples R China
5.Dalian Med Univ, Affiliated Hosp 1, Dalian, Peoples R China
6.Shanghai Jiao Tong Univ, Sch Med, Renji Hosp, Shanghai 200001, Peoples R China
7.Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Shanghai 200001, Peoples R China
8.Wenzhou Med Coll, Affiliated Hosp 1, Wenzhou, Peoples R China
9.Shanghai Jiao Tong Univ, Sch Med, Xinhua Hosp, Shanghai 200001, Peoples R China
10.Beijing Union Med Coll Hosp, Beijing, Peoples R China
11.Qingdao Univ, Coll Med, Affiliated Hosp, Qingdao 266071, Peoples R China
12.Nanjing Med Univ, Affiliated Hosp 1, Nanjing, Jiangsu, Peoples R China
13.Sun Yat Sen Univ, Affiliated Hosp 1, Guangzhou 510275, Guangdong, Peoples R China

Recommended Citation:
Yan, Yucheng,Qian, Jiaqi,Chen, Nan,et al. Efficacy and initial dose determination of paricalcitol for treatment of secondary hyperparathyroidism in Chinese subjects[J]. CLINICAL NEPHROLOGY,2014,81(1):20-29.
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