Please use this identifier to cite or link to this item: https://hdl.handle.net/1/150
Title: Cinacalcet HCl, An Oral Calcimimetic Agent for the Treatment of Secondary Hyperparathyroidism in Hemodialysis and Peritoneal Dialysis: A Randomized, Double-Blind, Multicenter Study
Authors: Lindberg, Jill S ;Culleton, Bruce ;Wong, Gordon ;Borah, Michael F ;Clark, Roderick V ;Shapiro, Warren B ;Roger, Simon D ;Husserl, Fred E ;Klassen, Preston S ;Guo, Matthew D ;Albizem, Moetaz B ;Coburn, Jack W 
Issue Date: Mar-2005
Source: Volume 16, Issue, pp. 800-807
Journal title: Journal of the American Society of Nephrology
Abstract: Management of secondary hyperparathyroidism is challenging with traditional therapy. The calcimimetic cinacalcet HCl acts on the calcium-sensing receptor to increase its sensitivity to calcium, thereby reducing parathyroid hormone (PTH) secretion. This phase 3, multicenter, randomized, placebo-controlled, double-blind study evaluated the efficacy and safety of cinacalcet in hemodialysis (HD) and peritoneal dialysis (PD) patients with PTH > or =300 pg/ml despite traditional therapy. A total of 395 patients received once-daily oral cinacalcet (260 HD, 34 PD) or placebo (89 HD, 12 PD) titrated from 30 to 180 mg to achieve a target intact PTH (iPTH) level of < or =250 pg/ml. During a 10-wk efficacy assessment phase, cinacalcet was more effective than control for PTH reduction outcomes, including proportion of patients with mean iPTH levels < or =300 pg/ml (46 versus 9%), proportion of patients with > or =30% reduction in iPTH from baseline (65 versus 13%), and proportion of patients with > or =20, > or =40, or > or =50% reduction from baseline. Cinacalcet had comparable efficacy in HD and PD patients; 50% of PD patients achieved a mean iPTH < or =300 pg/ml. Cinacalcet also significantly reduced serum calcium, phosphorus, and Ca x P levels compared with control treatment. The most common side effects, nausea and vomiting, were usually mild to moderate in severity and transient. Once-daily oral cinacalcet was effective in rapidly and safely reducing PTH, Ca x P, calcium, and phosphorus levels in patients who received HD or PD. Cinacalcet offers a new therapeutic option for controlling secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
Description: Open Access: http://jasn.asnjournals.org/content/16/3/800.full.pdf+html
URI: https://elibrary.cclhd.health.nsw.gov.au/cclhdjspui/handle/1/150
DOI: 10.1681/ASN.2004060512
Pubmed: http://www.ncbi.nlm.nih.gov/pubmed/15689407
ISSN: 1046-6673
Publicaton type: Journal Article
Keywords: Kidney Disease
Drug Therapy
Dialysis
Study or Trial: Randomized Controlled Clinical Trial/Controlled Clinical Trial
Appears in Collections:Renal Medicine

Show full item record

Page view(s)

24
checked on Mar 28, 2024

Google ScholarTM

Check

Altmetric


Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.