title: Efficacy and initial dose determination of paricalcitol for treatment of secondary hyperparathyroidism in Chinese subjects.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Subjects with SHPT (n = 216) undergoing hemodialysis were treated with paricalcitol i.v. for 12 weeks. One group was treated according to the EU paricalcitol package insert (PI) (initial μg dose based on iPTH/80), and the other was treated according to the US PI (initial dose of 0.04 μg/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.
  
  
  CONCLUSIONS
  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.
authors.forename: Yucheng
authors.initials: Y
authors.lastname: Yan
authors.forename: Jiaqi
authors.initials: J
authors.lastname: Qian
authors.forename: Nan
authors.initials: N
authors.lastname: Chen
authors.forename: Zhaoxing
authors.initials: Z
authors.lastname: Huang
authors.forename: Gengru
authors.initials: G
authors.lastname: Jiang
authors.forename: Xuewang
authors.initials: X
authors.lastname: Li
authors.forename: Hongli
authors.initials: H
authors.lastname: Lin
authors.forename: Liqiu
authors.initials: L
authors.lastname: Liu
authors.forename: Mei
authors.initials: M
authors.lastname: Wang
authors.forename: Changying
authors.initials: C
authors.lastname: Xing
authors.forename: Xueqing
authors.initials: X
authors.lastname: Yu
authors.forename: Li
authors.initials: L
authors.lastname: Zuo
authors.forename: Michael
authors.initials: M
authors.lastname: Amdahl
authors.forename: Samina
authors.initials: S
authors.lastname: Khan
mesh_terms: D000328:Adult; D000368:Aged; D002118:Calcium / Q000097:blood; D004872:Ergocalciferols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood; D010758:Phosphorus / Q000097:blood; D016037:Single-Blind Method
chemical_list: D004872:Ergocalciferols; D010281:Parathyroid Hormone; D010758:Phosphorus; C084656:paricalcitol; D002118:Calcium