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Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study.
J Am Soc Nephrol. 2005 Mar; 16(3):800-7.JA

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.

Authors+Show Affiliations

New Orleans Nephrology Associates, 4228 Houma Boulevard, Metairie, LA 70006, USA. jlindberg@bellsouth.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15689407

Citation

Lindberg, Jill S., et al. "Cinacalcet HCl, an Oral Calcimimetic Agent for the Treatment of Secondary Hyperparathyroidism in Hemodialysis and Peritoneal Dialysis: a Randomized, Double-blind, Multicenter Study." Journal of the American Society of Nephrology : JASN, vol. 16, no. 3, 2005, pp. 800-7.
Lindberg JS, Culleton B, Wong G, et al. Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study. J Am Soc Nephrol. 2005;16(3):800-7.
Lindberg, J. S., Culleton, B., Wong, G., Borah, M. F., Clark, R. V., Shapiro, W. B., Roger, S. D., Husserl, F. E., Klassen, P. S., Guo, M. D., Albizem, M. B., & Coburn, J. W. (2005). Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study. Journal of the American Society of Nephrology : JASN, 16(3), 800-7.
Lindberg JS, et al. Cinacalcet HCl, an Oral Calcimimetic Agent for the Treatment of Secondary Hyperparathyroidism in Hemodialysis and Peritoneal Dialysis: a Randomized, Double-blind, Multicenter Study. J Am Soc Nephrol. 2005;16(3):800-7. PubMed PMID: 15689407.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study. AU - Lindberg,Jill S, AU - Culleton,Bruce, AU - Wong,Gordon, AU - Borah,Michael F, AU - Clark,Roderick V, AU - Shapiro,Warren B, AU - Roger,Simon D, AU - Husserl,Fred E, AU - Klassen,Preston S, AU - Guo,Matthew D, AU - Albizem,Moetaz B, AU - Coburn,Jack W, Y1 - 2005/02/02/ PY - 2005/2/4/pubmed PY - 2005/6/29/medline PY - 2005/2/4/entrez SP - 800 EP - 7 JF - Journal of the American Society of Nephrology : JASN JO - J. Am. Soc. Nephrol. VL - 16 IS - 3 N2 - 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. SN - 1046-6673 UR - https://www.unboundmedicine.com/medline/citation/15689407/Cinacalcet_HCl_an_oral_calcimimetic_agent_for_the_treatment_of_secondary_hyperparathyroidism_in_hemodialysis_and_peritoneal_dialysis:_a_randomized_double_blind_multicenter_study_ L2 - http://jasn.asnjournals.org/cgi/pmidlookup?view=long&amp;pmid=15689407 DB - PRIME DP - Unbound Medicine ER -