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- Title
Cinacalcet HCl reduces hypercalcemia in primary hyperparathyroidism across a wide spectrum of disease severity.
- Authors
Peacock, Munro; Bilezikian, J P; Bolognese, M A; Borofsky, Michael; Scumpia, Simona; Sterling, L R; Cheng, Sunfa; Shoback, Dolores
- Abstract
<bold>Context: </bold>Primary hyperparathyroidism (PHPT) is characterized by elevated serum calcium (Ca) and increased PTH concentrations.<bold>Objective: </bold>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.<bold>Design and Setting: </bold>The study was a pooled analysis of data from three multicenter clinical trials of cinacalcet in PHPT.<bold>Patients: </bold>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).<bold>Intervention: </bold>The intervention in this study was treatment with cinacalcet for up to 4.5 yr.<bold>Outcomes: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>Cinacalcet is equally effective in the medical management of PHPT patients across a broad spectrum of disease severity, and overall cinacalcet is well tolerated.
- Subjects
HYDROCARBONS; ADRENALECTOMY; ALKALINE phosphatase; ANALYSIS of variance; CALCIUM; COMPARATIVE studies; HYPERCALCEMIA; HYPERPARATHYROIDISM; RESEARCH methodology; MEDICAL cooperation; PARATHYROID hormone; PHOSPHATES; RESEARCH; RESEARCH funding; EVALUATION research; BONE density; TREATMENT effectiveness; BLIND experiment; SEVERITY of illness index; PHOTON absorptiometry; DISEASE complications; THERAPEUTICS
- Publication
Journal of Clinical Endocrinology & Metabolism, 2011, Vol 96, Issue 1, pE9
- ISSN
0021-972X
- Publication type
journal article
- DOI
10.1210/jc.2010-1221