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Cinacalcet: An oral calcimimetic agent for the management of hyperparathyroidism.
Clin Ther. 2005 Nov; 27(11):1725-51.CT

Abstract

BACKGROUND

Uncontrolled hyperparathyroidism (HPT), particularly HPT resulting from chronic kidney disease (CKD), is associated with significant morbidity and cardiovascular mortality. Traditional medical therapy (eg, vitamin D sterols, calcium, phosphate binders) has been inadequate for the management of HPT and its vascular and skeletal complications.

OBJECTIVE

: The goal of this article was to review the efficacy and safety profile of cinacalcet, a second-generation calcimimetic, in the management of HPT secondary to CKD, primary HPT, and parathyroid carcinoma.

METHODS

MEDLINE, Web of Science, and International Pharmaceutical Abstracts were searched from 1995 to July 2005 using the terms cinacalcet, AMG 073, KRN 1493, calcimimetics, hypercalcemia, and hyperparathyroidism.

RESULTS

Compared with placebo, cinacalcet significantly reduced parathyroid hormone levels within 2 to 4 hours after administration (P < 0.05). In Phase III trials involving 1136 patients with secondary HPT, 56% of those who received cinacalcet achieved the National Kidney Foundation Kidney Disease Outcomes Quality Initiative target of a reduction in parathyroid hormone to <300 pg/mL, 65% achieved a calcium-phosphorus product <55 mg2/dL2, and a respective 49% and 46% achieved normalized serum calcium and phosphorus levels (P < 0.001). Cinacalcet's effects were similar regardless of patients' demographic characteristics, duration or mode of dialysis, severity of HPT, or use of concomitant medical therapy. Preliminary evidence suggests that cinacalcet may reverse cortical bone loss. Cinacalcet was well tolerated, with nausea (31%) and vomiting (27%) being the most commonly reported adverse effects. Hypocalcemia was transient in 5% of patients, was usually asymptomatic, and was corrected by dose reduction.

CONCLUSIONS

Based on the available evidence, cinacalcet is effective and well tolerated in the treatment of secondary HPT and refractory parathyroid carcinoma. Its use in primary HPT appears promising. Further investigations are needed to determine if cinacalcet can prevent the long-term complications of HPT and reduce mortality.

Authors+Show Affiliations

School of Pharmacy, University of California-San Francisco, 521 Parnassus Avenue C-152, San Francisco, CA 94143-0622, USA. dongb@pharmacy.ucsf.edu

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

16368445

Citation

Dong, Betty J.. "Cinacalcet: an Oral Calcimimetic Agent for the Management of Hyperparathyroidism." Clinical Therapeutics, vol. 27, no. 11, 2005, pp. 1725-51.
Dong BJ. Cinacalcet: An oral calcimimetic agent for the management of hyperparathyroidism. Clin Ther. 2005;27(11):1725-51.
Dong, B. J. (2005). Cinacalcet: An oral calcimimetic agent for the management of hyperparathyroidism. Clinical Therapeutics, 27(11), 1725-51.
Dong BJ. Cinacalcet: an Oral Calcimimetic Agent for the Management of Hyperparathyroidism. Clin Ther. 2005;27(11):1725-51. PubMed PMID: 16368445.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cinacalcet: An oral calcimimetic agent for the management of hyperparathyroidism. A1 - Dong,Betty J, PY - 2005/07/21/accepted PY - 2005/12/22/pubmed PY - 2006/3/21/medline PY - 2005/12/22/entrez SP - 1725 EP - 51 JF - Clinical therapeutics JO - Clin Ther VL - 27 IS - 11 N2 - BACKGROUND: Uncontrolled hyperparathyroidism (HPT), particularly HPT resulting from chronic kidney disease (CKD), is associated with significant morbidity and cardiovascular mortality. Traditional medical therapy (eg, vitamin D sterols, calcium, phosphate binders) has been inadequate for the management of HPT and its vascular and skeletal complications. OBJECTIVE: : The goal of this article was to review the efficacy and safety profile of cinacalcet, a second-generation calcimimetic, in the management of HPT secondary to CKD, primary HPT, and parathyroid carcinoma. METHODS: MEDLINE, Web of Science, and International Pharmaceutical Abstracts were searched from 1995 to July 2005 using the terms cinacalcet, AMG 073, KRN 1493, calcimimetics, hypercalcemia, and hyperparathyroidism. RESULTS: Compared with placebo, cinacalcet significantly reduced parathyroid hormone levels within 2 to 4 hours after administration (P < 0.05). In Phase III trials involving 1136 patients with secondary HPT, 56% of those who received cinacalcet achieved the National Kidney Foundation Kidney Disease Outcomes Quality Initiative target of a reduction in parathyroid hormone to <300 pg/mL, 65% achieved a calcium-phosphorus product <55 mg2/dL2, and a respective 49% and 46% achieved normalized serum calcium and phosphorus levels (P < 0.001). Cinacalcet's effects were similar regardless of patients' demographic characteristics, duration or mode of dialysis, severity of HPT, or use of concomitant medical therapy. Preliminary evidence suggests that cinacalcet may reverse cortical bone loss. Cinacalcet was well tolerated, with nausea (31%) and vomiting (27%) being the most commonly reported adverse effects. Hypocalcemia was transient in 5% of patients, was usually asymptomatic, and was corrected by dose reduction. CONCLUSIONS: Based on the available evidence, cinacalcet is effective and well tolerated in the treatment of secondary HPT and refractory parathyroid carcinoma. Its use in primary HPT appears promising. Further investigations are needed to determine if cinacalcet can prevent the long-term complications of HPT and reduce mortality. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/16368445/Cinacalcet:_An_oral_calcimimetic_agent_for_the_management_of_hyperparathyroidism_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(05)00294-8 DB - PRIME DP - Unbound Medicine ER -