Cinacalcet lowering of serum fibroblast growth factor-23 concentration may be independent from serum Ca, P, PTH and dose of active vitamin D in peritoneal dialysis patients: a randomized controlled study

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• 作者：Hyo Jin Kim (1)
  Hyunsuk Kim (1)
  Nara Shin (1)
  Ki Young Na (2)
  Yong Lim Kim (3)
  Daejung Kim (4)
  Jae Hyun Chang (5)
  Young Rim Song (6)
  Young-Hwan Hwang (7)
  Yon Su Kim (1)
  Curie Ahn (1)
  Joongyub Lee (8)
  Kook-Hwan Oh (1)
  
• 关键词：Cinacalcet ; Fibroblast growth factor 23 ; Peritoneal dialysis
• 刊名：BMC Nephrology
• 出版年：2013
• 出版时间：December 2013
• 年：2013
• 卷：14
• 期：1
• 全文大小：353KB
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  26. The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2369/14/112/prepub
  
• 作者单位：Hyo Jin Kim (1)
  Hyunsuk Kim (1)
  Nara Shin (1)
  Ki Young Na (2)
  Yong Lim Kim (3)
  Daejung Kim (4)
  Jae Hyun Chang (5)
  Young Rim Song (6)
  Young-Hwan Hwang (7)
  Yon Su Kim (1)
  Curie Ahn (1)
  Joongyub Lee (8)
  Kook-Hwan Oh (1)
  
  1. Department of Internal Medicine, Seoul National University, Seoul, Korea
  2. Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea
  3. Department of Internal Medicine, Kyungpook National University, Daegu, Korea
  4. Department of Internal Medicine, Sungkyunkwan University, Seoul, Korea
  5. Department of Internal Medicine, Gachon University, Incheon, Korea
  6. Department of Internal Medicine, Hallym University, Seoul, Korea
  7. Department of Internal Medicine, Eulji University, Seoul, Korea
  8. Medical Research Collaborating Center, Seoul National University Hospital, Seoul, Korea
  

文摘

Background Elevated serum level of fibroblast growth factor-23 (FGF23) is associated with adverse outcomes in dialyzed patients. Objectives The CUPID study compared the efficacy of a cinacalcet-based regimen with conventional care (vitamin D and P binders) for achieving the stringent NKF-K/DOQI targets for peritoneal dialysis (PD) patients. Additionally, we analyzed change in FGF23 levels between two treatments to explore the cinacalcet effect in lowering FGF23. Design Multicenter, open-labeled, randomized controlled study. Setting Seven university-affiliated hospitals in Korea. Participants Overall, 66 peritoneal dialysis patients were enrolled. Intervention Sixty six patients were randomly assigned to treatment with either cinacalcet + oral vitamin D (cinacalcet group, n = 33) or oral vitamin D alone (control group, n = 33) to achieve K/DOQI targets. CUPID included a 4-week screening for vitamin D washout, a 12-week dose-titration, and a 4-week assessment phases. We calculated mean values of iPTH, Ca, P, Ca x P, during assessment phase and final FGF23 to assess the outcome. Main outcome measures Achievement of >30% reduction of iPTH from baseline (primary) and FGF23 reduction (secondary). Results 72.7% (n = 24) of the cinacalcet group and 93.9% (n = 31) of the control group completed the study. Cinacalcet group received 30.2 ± 18.0 mg/day of cinacalcet and 0.13 ± 0.32 μg/d oral vitamin D (P < 0.001 vs. control with 0.27 ± 0.18 μg/d vitamin D). The proportion of patients who reached the primary endpoint was not statistically different (48.5% vs. 51.5%, cinacalcet vs. control, P = 1.000). After treatment, cinacalcet group experienced a significant reduction in FGF23 levels (median value from 3,960 to 2,325 RU/ml, P = 0.002), while an insignificant change was shown for control group (from 2,085 to 2,415 RU/ml). The percent change of FGF23 after treatment was also significantly different between the two groups (?42.54% vs. 15.83%, P = 0.008). After adjustment, cinacalcet treatment was independently associated with the serum FGF23 reduction. Conclusion Cinacalcet treatment was independently associated with the reduction of FGF23 in our PD patients. Trial registration Controlled trials NCT01101113