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学科主题: 临床医学
题名:
Sevelamer carbonate lowers serum phosphorus effectively in haemodialysis patients: a randomized, double-blind, placebo-controlled, dose-titration study
作者: Chen, Nan1; Wu, Xiongfei2; Ding, Xiaoqiang3; Mei, Changlin4; Fu, Ping5; Jiang, Gengru6; Li, Xuemei7; Chen, Jianghua8; Liu, Bicheng9; La, Yan10; Hou, Fanfan11; Ni, Zhaohui12; Fu, Junzhou13; Xing, Changying14; Yu, Xuequing15; Huang, Chaoxing16; Zuo, Li17; Wang, Li18; Hunter, John19; Dillon, Maureen19; Plone, Melissa19; Neylan, John19
关键词: clinical study ; haemodialysis ; hyperphosphataemia ; placebo ; sevelamer carbonate
刊名: NEPHROLOGY DIALYSIS TRANSPLANTATION
发表日期: 2014
DOI: 10.1093/ndt/gft232
卷: 29, 期:1, 页:152-160
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Transplantation ; Urology & Nephrology
研究领域[WOS]: Transplantation ; Urology & Nephrology
关键词[WOS]: CHRONIC KIDNEY-DISEASE ; FREE PHOSPHATE BINDER ; CHRONIC-RENAL-FAILURE ; PARATHYROID-HORMONE ; MINERAL METABOLISM ; LANTHANUM CARBONATE ; DIALYSIS OUTCOMES ; PRACTICE PATTERNS ; CROSSOVER DESIGN ; CALCIUM ACETATE
英文摘要:

Hyperphosphataemia in patients with advanced chronic kidney disease (CKD) is associated with adverse outcomes, including vascular calcification and higher mortality rates. While phosphate lowering is an integral aspect of CKD management, the efficacy and safety of phosphate binders in a contemporary cohort of Chinese haemodialysis patients (who have different genetics and dietary patterns than other populations) has not been previously described. Moreover, sparse data are available on strategies for optimal dose titration when transitioning from a calcium-based to a polymer-based phosphate binder.

This randomized, double-blind, dose-titration study compared sevelamer carbonate (starting dose 800 mg three times daily) with placebo over 8 weeks duration in Chinese CKD patients on haemodialysis. Patients were required to be using calcium-based binders prior to study start.

In all, 205 patients were randomized (sevelamer, n 135; placebo, n 70); mean age was 48.6 years, 61 were male and the mean time on dialysis was 4.4 years. The mean serum phosphorus decreased significantly in patients treated with sevelamer carbonate [change 0.69 0.64 mmol/L (2.14 1.98 mg/dL)] but remained persistently elevated with placebo [change 0.06 0.57 mmol/L (0.19 1.76 mg/dL)] (P 0.0001). When compared with placebo, sevelamer carbonate treatment resulted in statistically significant greater mean reductions from baseline in serum total (17.1 versus 3.3) and low-density lipoprotein cholesterol (33.5 versus7.6) (P 0.0001 for both). Sevelamer carbonate was well tolerated with 96 adherence compared with 97 adherence in the placebo arm. Overall, adverse events experienced by patients in the sevelamer carbonate and placebo treatment groups were similar and consistent with their underlying renal disease.

This study demonstrated that hyperphosphataemia developed quickly following the cessation of phosphate binders and remained persistently elevated in end-stage CKD in the placebo-treated group. Gradually titrating up sevelamer carbonate from an initial dose of 2.4 g/day to an average daily dose of 7.1 2.5 g/day was well tolerated, safe and efficacious in contemporary Chinese haemodialysis patients.

语种: 英语
所属项目编号: SVCARB03808
项目资助者: Sanofi ; Genzyme Corporation
WOS记录号: WOS:000330664000021
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/60926
Appears in Collections:北京大学第一临床医学院_期刊论文

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作者单位: 1.Genzyme Corp, Cambridge, MA USA
2.Shanghai Ruijin Hosp, Shanghai, Peoples R China
3.Southwest Hosp, Chongqing, Peoples R China
4.Fudan Univ, Zhongshan Hosp, Shanghai 200433, Peoples R China
5.Shanghai Changzheng Hosp, Shanghai, Peoples R China
6.Peking Univ, Hosp 1, Beijing 100871, Peoples R China
7.Sichuan Prov Peoples Hosp, Chengdu, Peoples R China
8.Sichuan Univ, West China Hosp, Chengdu 610064, Peoples R China
9.Qingdao Municipal Hosp, Eastern Hosp, Qingdao, Peoples R China
10.Nanfang Hosp, Guangzhou, Guangdong, Peoples R China
11.Jiangsu Prov Hosp, Nanjing, Jiangsu, Peoples R China
12.Shanghai Jiao Tong Univ, Sch Med, Xinhua Hosp, Shanghai 200030, Peoples R China
13.Beijing Union Med Coll Hosp, Beijing, Peoples R China
14.Zhejiang Univ, Affiliated Hosp 1, Coll Med, Hangzhou 310003, Zhejiang, Peoples R China
15.Southeast Univ, Zhongda Hosp, Nanjing, Jiangsu, Peoples R China
16.Shanghai Jiao Tong Univ, Sch Med, Renji Hosp, Shanghai 200030, Peoples R China
17.Guangzhou First Municipal Peoples Hosp, Guangzhou, Guangdong, Peoples R China
18.Sun Yat Sen Univ, Affiliated Hosp 1, Guangzhou 510275, Guangdong, Peoples R China
19.Wenzhou Med Coll, Affiliated Hosp 1, Wenzhou, Peoples R China

Recommended Citation:
Chen, Nan,Wu, Xiongfei,Ding, Xiaoqiang,et al. Sevelamer carbonate lowers serum phosphorus effectively in haemodialysis patients: a randomized, double-blind, placebo-controlled, dose-titration study[J]. NEPHROLOGY DIALYSIS TRANSPLANTATION,2014,29(1):152-160.
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