| A Randomised Controlled Trial to Compare the Efficacy and Safety of Oral Paricalcitol with Oral Calcitriol in Dialysis Patients with Secondary Hyperparathyroidism. | |
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MedLine Citation:
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PMID: 23311404 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: JOURNAL ARTICLE Date: 2013-1-13 |
Journal Detail:
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Title: Nephrology (Carlton, Vic.) Volume: - ISSN: 1440-1797 ISO Abbreviation: Nephrology (Carlton) Publication Date: 2013 Jan |
Date Detail:
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Created Date: 2013-1-14 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9615568 Medline TA: Nephrology (Carlton) Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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© 2013 The Authors. Nephrology © 2013 Asian Pacific Society of Nephrology. |
Affiliation:
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Penang Hospital. |
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