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Cinacalcet Hydrochloride Maintains Long-Term Normocalcemia in Patients with Primary Hyperparathyroidism

Department of Medicine (M.P.), Indiana University School of Medicine, Indianapolis, Indiana 46202; Department of Medicine (J.P.B.), College of Physicians and Surgeons, Columbia University, New York, New York 10032; Amgen Inc. (P.S.K., M.D.G., S.A.T.), Thousand Oaks, California 91320; and Department of Veterans Affairs Medical Center (D.S.), Department of Medicine, University of California, San Francisco, California 94121

Address all correspondence and requests for reprints to: Munro Peacock, M.D., Director, General Clinical Research Center, University Hospital, 550 University Boulevard, UH5595, Indianapolis, Indiana 46202. E-mail: mpeacock{at}iupui.edu.

Calcimimetics increase the sensitivity of parathyroid calcium-sensing receptors to extracellular calcium, thereby reducing PTH secretion. This multicenter, randomized, double-blind, placebo-controlled study assessed the ability of the oral calcimimetic cinacalcet HCl to achieve long-term reductions in serum calcium and PTH concentrations in patients with primary hyperparathyroidism (HPT). Patients (n = 78) were randomized to cinacalcet or placebo. Cinacalcet was titrated from 30–50 mg twice daily during a 12-wk dose-titration phase. Efficacy was assessed during 12-wk maintenance and 28-wk follow-up phases. The primary endpoint was the achievement of normocalcemia [serum calcium 10.3 mg/dl (2.57 mmol/liter)] with at least 0.5 mg/dl (0.12-mmol/liter) reduction from baseline. Plasma PTH, serum and urine biochemistry, biochemical measures of bone turnover, bone mineral density, and safety were also assessed. Seventy-three percent of cinacalcet-treated patients vs. only 5% of placebo-treated patients achieved the primary endpoint (P < 0.001). Fasting predose plasma PTH decreased 7.6% in cinacalcet patients but increased 7.7% in placebo patients (P < 0.01). Bone mineral density was unchanged by cinacalcet, but bone resorption and formation markers increased (P < 0.05). Adverse events were mild and similar between treatment groups. Cinacalcet rapidly normalizes serum calcium and reduces PTH in patients with primary HPT, and these effects are maintained with long-term treatment. Cinacalcet may be an effective, nonsurgical approach for management of primary HPT.

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