Cinacalcet reduces serum calcium concentrations in patients with intractable primary hyperparathyroidism

Claudio Marcocci, Philippe Chanson, Dolores Shoback, John Bilezikian, Laureano Fernandez-Cruz, Jacques Orgiazzi, Christoph Henzen, Sunfa Cheng, Lulu Ren Sterling, John Lu, Munro Peacock

Research output: Contribution to journalArticle

106 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)2766-2772
Number of pages7
JournalJournal of Clinical Endocrinology and Metabolism
Volume94
Issue number8
DOIs
StatePublished - Aug 2009

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Biochemistry
  • Endocrinology
  • Clinical Biochemistry
  • Biochemistry, medical

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    Marcocci, C., Chanson, P., Shoback, D., Bilezikian, J., Fernandez-Cruz, L., Orgiazzi, J., Henzen, C., Cheng, S., Sterling, L. R., Lu, J., & Peacock, M. (2009). Cinacalcet reduces serum calcium concentrations in patients with intractable primary hyperparathyroidism. Journal of Clinical Endocrinology and Metabolism, 94(8), 2766-2772. https://doi.org/10.1210/jc.2008-2640