title: Randomized controlled trial to compare the efficacy and safety of oral paricalcitol with oral calcitriol in dialysis patients with secondary hyperparathyroidism.
abstract: OBJECTIVE
  The objective of the study was to compare the efficacy and safety of oral paricalcitol with oral calcitriol for treating secondary hyperparathyroidism.
  
  
  METHODS
  We conducted the first multicenter open-labelled parallel group randomized controlled trial in 66 patients on dialysis. Patients were randomized to paricalcitol or calcitriol at a 3:1 dose ratio and adjusted to maintain intact parathyroid hormone (iPTH) level between 150-300 pg/mL, serum calcium ≤2.74 mmol/L and calcium-phosphate product ≤5.63 mmol(2) /L(2). The primary end point was the proportion of patients who achieved >30% reduction in iPTH.
  
  
  RESULTS
  At 24 weeks, 22 (61.1%) patients in the paricalcitol and 22 (73.3%) in the calcitriol group had achieved the primary end-point (P-value = 0.29). The cumulative proportion of patients who achieved the end-point at 6 weeks, 12 weeks and 24 weeks were 50%, 80.6% and 86.1%, respectively, in paricalcitol and 53.3%, 86.7% and 86.7%, respectively, in the calcitriol group (P-value = 0.67). Median time to the end-point was 6 weeks in both groups. There were no significant differences in iPTH level at any time during the study. The median reduction in iPTH at 24 weeks was 48.4% in the paricalcitol group and 41.9% in the calcitriol group (P-value = 0.6). The median maximal iPTH reduction was 77.1% (paricalcitol) and 83.7% (calcitriol), P-value = 0.3. Serum calcium and incidence of hypercalcaemia did not differ between groups. 16.7% of patients in both groups had at least one episode of hypercalcaemia (serum calcium >2.74 mmol/L). Other adverse events were similar between groups.
  
  
  CONCLUSIONS
  Our study suggests that oral paricalcitol has similar efficacy and safety to oral calcitriol.
authors: Penang Hospital, Georgetown, Malaysia. onglokemeng@gmail.com
authors: Loke Meng
authors: LM
authors: Ong
authors: Punithavathi
authors: P
authors: Narayanan
authors: Heong Keong
authors: HK
authors: Goh
authors: Anita Bhajan
authors: AB
authors: Manocha
authors: Ahmad
authors: A
authors: Ghazali
authors: Mahanim
authors: M
authors: Omar
authors: Sukeri
authors: S
authors: Mohamad
authors: Bak-Leong
authors: BL
authors: Goh
authors: Shahnaz
authors: S
authors: Shah
authors: Mohd Ramli
authors: MR
authors: Seman
authors: Indralingam
authors: I
authors: Vaithilingam
authors: Rozina
authors: R
authors: Ghazalli
authors: Korina
authors: K
authors: Rahmat
authors: Wan
authors: W
authors: Shaariah
authors: Chen Hua
authors: CH
authors: Ching
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000469:Alkaline Phosphatase / Q000097:blood; D000704:Analysis of Variance; D015415:Biomarkers / Q000097:blood; D002117:Calcitriol / Q000008:administration & dosage* / Q000009:adverse effects; D002118:Calcium / Q000097:blood; D016009:Chi-Square Distribution; D015536:Down-Regulation; D004872:Ergocalciferols / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D053208:Kaplan-Meier Estimate; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy*; D008296:Malaysia; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood; D010710:Phosphates / Q000097:blood; D006435:Renal Dialysis / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D004872:Ergocalciferols; C470125:PTH protein, human; D010281:Parathyroid Hormone; D010710:Phosphates; C084656:paricalcitol; D000469:Alkaline Phosphatase; D002117:Calcitriol; D002118:Calcium