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Claudio Marcocci, Philippe Chanson, Dolores Shoback, John Bilezikian, Laureano Fernandez-Cruz, Jacques Orgiazzi, Christoph Henzen, Sunfa Cheng, Lulu Ren Sterling, John Lu, Munro Peacock, Cinacalcet Reduces Serum Calcium Concentrations in Patients with Intractable Primary Hyperparathyroidism, The Journal of Clinical Endocrinology & Metabolism, Volume 94, Issue 8, 1 August 2009, Pages 2766–2772, https://doi.org/10.1210/jc.2008-2640
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Context: Patients with persistent primary hyperparathyroidism (PHPT) after parathyroidectomy or with contraindications to parathyroidectomy often require chronic treatment for hypercalcemia.
Objective: The objective of the study was to assess the ability of the calcimimetic, cinacalcet, to reduce serum calcium in patients with intractable PHPT.
Design: This was an open-label, single-arm study comprising a titration phase of variable duration (2–16 wk) and a maintenance phase of up to 136 wk.
Setting: The study was conducted at 23 centers in Europe, the United States, and Canada.
Patients: The study included 17 patients with intractable PHPT and serum calcium greater than 12.5 mg/dl (3.1 mmol/liter).
Intervention: During the titration phase, cinacalcet dosages were titrated every 2 wk (30 mg twice daily to 90 mg four times daily) for 16 wk until serum calcium was 10 mg/dl or less (2.5 mmol/liter). If serum calcium increased during the maintenance phase, additional increases in the cinacalcet dose were permitted.
Main Outcome Measure: The primary end point was the proportion of patients experiencing a reduction in serum calcium of 1 mg/dl or greater (0.25 mmol/liter) at the end of the titration phase.
Results: Mean ± sd baseline serum calcium was 12.7 ± 0.8 mg/dl (3.2 ± 0.2 mmol/liter). At the end of titration, a 1 mg/dl or greater reduction in serum calcium was achieved in 15 patients (88%). Fifteen patients (88%) experienced treatment-related adverse events, none of which were serious. The most common adverse events were nausea, vomiting, and paresthesias.
Conclusions: In patients with intractable PHPT, cinacalcet reduces serum calcium, is generally well tolerated, and has the potential to fulfill an unmet medical need.
