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Cinacalcet Reduces Serum Calcium Concentrations in Patients with Intractable Primary Hyperparathyroidism

Department of Endocrinology and Metabolism (C.M.), University of Pisa, 56124 Pisa, Italy; Department of Endocrinology and Reproductive Diseases (P.C.), Assistance Publique-Hôpitaux de Paris, Hôpital de Bicêtre and Université Paris-Sud 11, 94275 Le Kremlin-Bicêtre, France; Endocrine Research Unit (D.S.), San Francisco Veterans Affairs Medical Center and Department of Medicine, University of California, San Francisco, California 94143; College of Physicians and Surgeons (J.B.), Columbia University, New York, New York 10032; University of Barcelona (L.F.-C.), 08028 Barcelona, Spain; Service d’Endocrinologie-Diabétologie (J.O.), Centre Hospitalier Lyon Sud, Université Claude-Bernard Lyon-1, 69495 Pierre-Bénite, France; Endokrinologie-Diabetologie Kantonsspital (C.H.), Luzern, Switzerland; Amgen Inc. (S.C., L.R.S., J.L.), Thousand Oaks, California 91320; and Indiana University School of Medicine (M.P.), Indianapolis, Indiana 46202

Address all correspondence and requests for reprints to: Claudio Marcocci, M.D., Department of Endocrinology and Metabolism, University of Pisa, Via Paradisa 2, 56124 Pisa, Italy, E-mail: c.marcocci{at}endoc.med.unipi.it.

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.

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