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J Clin Endocrinol Metab. 2011 Jan;96(1):E9-18. doi: 10.1210/jc.2010-1221. Epub 2010 Oct 13.

Cinacalcet HCl reduces hypercalcemia in primary hyperparathyroidism across a wide spectrum of disease severity.

Author information

  • 1Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana 46202, USA. mpeacock@iupui.edu

Abstract

CONTEXT:

Primary hyperparathyroidism (PHPT) is characterized by elevated serum calcium (Ca) and increased PTH concentrations.

OBJECTIVE:

The objective of the investigation was to establish the efficacy of cinacalcet in reducing serum Ca in patients with PHPT across a wide spectrum of disease severity.

DESIGN AND SETTING:

The study was a pooled analysis of data from three multicenter clinical trials of cinacalcet in PHPT.

PATIENTS:

Patients were grouped into three disease categories for analysis based on the following: 1) history of failed parathyroidectomy (n = 29); 2) meeting one or more criteria for parathyroidectomy but without prior surgery (n = 37); and 3) mild asymptomatic PHPT without meeting criteria for either above category (n = 15).

INTERVENTION:

The intervention in this study was treatment with cinacalcet for up to 4.5 yr.

OUTCOMES:

Measurements in the study included serum Ca, PTH, phosphate, and bone-specific alkaline phosphatase, and areal bone mineral density (aBMD). Vital signs, safety biochemical and hematological indices, and adverse events were monitored throughout the study period.

RESULTS:

The extent of cinacalcet-induced serum Ca reduction, proportion of patients achieving normal serum Ca (≤10.3 mg/dl), reduction in serum PTH, and increase in serum phosphate were similar across all three categories. Except for decreased aBMD at the total femur indicated for parathyroidectomy group at 1 yr, no significant changes in aBMD occurred. The efficacy of cinacalcet was maintained for up to 4.5 yr of follow-up. AEs were mild and similar across the three categories.

CONCLUSIONS:

Cinacalcet is equally effective in the medical management of PHPT patients across a broad spectrum of disease severity, and overall cinacalcet is well tolerated.

PMID:
20943783
[PubMed - indexed for MEDLINE]
PMCID:
PMC3203649
Free PMC Article
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