Document Detail

A Randomised Controlled Trial to Compare the Efficacy and Safety of Oral Paricalcitol with Oral Calcitriol in Dialysis Patients with Secondary Hyperparathyroidism.
MedLine Citation:
PMID:  23311404     Owner:  NLM     Status:  Publisher    
AIM: 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 randomised 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 150-300pg/ml, serum calcium <=2.74mmol/l and calcium-phosphate product <=5.63mmol2/l2. 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 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 >2.74mmol/l). Other adverse events were similar between groups. CONCLUSION: Our study suggests that oral paricalcitol has similar efficacy and safety to oral calcitriol.
Loke Meng Ong; Punithavathi Narayanan; Heong Keong Goh; Anita Bhajan Manocha; Ghazali Tv Ahmad; Mahanim Omar; Sukeri Mohamad; Bak-Leong Goh; Shahnaz Shah; Mohd Ramli Seman; Ndralingam Vaithilingam; Rozina Ghazalli; Korina Rahmat; Wan Shaariah; Chen Hua Ching;
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-13
Journal Detail:
Title:  Nephrology (Carlton, Vic.)     Volume:  -     ISSN:  1440-1797     ISO Abbreviation:  Nephrology (Carlton)     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-14     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9615568     Medline TA:  Nephrology (Carlton)     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2013 The Authors. Nephrology © 2013 Asian Pacific Society of Nephrology.
Penang Hospital.
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