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Cinacalcet HCl reduces hypercalcemia in primary hyperparathyroidism across a wide spectrum of disease severity
Munro Peacock1, J P Bilezikian, M A Bolognese
1Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana 46202, USA. mpeacock@iupui.edu
Insights
Cinacalcet effectively lowers serum calcium in primary hyperparathyroidism (PHPT) patients, regardless of disease severity. This treatment is well-tolerated and maintains efficacy over 4.5 years.
Area of Science:
- Endocrinology
- Pharmacology
- Clinical Medicine
Background:
- Primary hyperparathyroidism (PHPT) is a condition marked by high serum calcium and parathyroid hormone (PTH) levels.
- Effective management strategies are crucial for patients with PHPT.
Purpose of the Study:
- To evaluate the efficacy of cinacalcet in reducing serum calcium in PHPT patients.
- To assess cinacalcet's effectiveness across diverse PHPT disease severities.
Main Methods:
- Pooled analysis of data from three multicenter clinical trials involving cinacalcet for PHPT.
- Patients categorized into three groups: prior parathyroidectomy, surgical candidates, and mild asymptomatic PHPT.
- Treatment involved cinacalcet for up to 4.5 years, with monitoring of serum calcium, PTH, phosphate, and bone mineral density.
Main Results:
- Cinacalcet demonstrated similar efficacy in reducing serum calcium and PTH across all patient categories.
- A significant proportion of patients achieved normal serum calcium levels (≤10.3 mg/dL).
- Treatment was well-tolerated with mild adverse events, and efficacy was sustained over the follow-up period.
Conclusions:
- Cinacalcet is an effective treatment option for managing PHPT across a wide spectrum of disease severity.
- The drug is generally well-tolerated and maintains its therapeutic effect long-term.
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.
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