Long-term treatment of secondary hyperparathyroidism with the calcimimetic cinacalcet HCl

Sharon M. Moe, John Cunningham, Jürgen Bommer, Stephen Adler, Steven J. Rosansky, Pablo Urena-Torres, Moetaz B. Albizem, Matthew D. Guo, Valter J. Zani, William G. Goodman, Stuart M. Sprague

Research output: Contribution to journalArticlepeer-review

123 Scopus citations

Abstract

Background. Patients with secondary hyperparathyroidism often require therapy that provides long-term control of parathyroid hormone concentrations without increasing calcium and phosphorus concentrations. Cinacalcet modulates the calcium-sensing receptor on the parathyroid gland to reduce secretion of parathyroid hormone and lower serum calcium, phosphorus and calcium-phosphorus product in haemodialysis patients. Methods. Dialysis patients with secondary hyperparathyroidism [parathyroid hormone (PTH) level ≥300 pg/ml] who were enrolled in one of four phase 2 placebo-controlled studies were eligible to enrol in an open-label extension study in which all patients received cinacalcet. For this extension study, cinacalcet was initiated at 30 mg in all patients and the dose was escalated to a maximum of 180 mg once daily if PTH concentrations were >250 pg/ml. Use of concomitant vitamin D sterols and phosphate binders was not restricted. Results. The analysis of all patients (n = 59) completing 100 weeks of cinacalcet treatment showed long-term control of PTH and calcium-phosphorus product. Approximately 55% achieved a PTH concentration ≤300 pg/ml at the week-100 study visit, and ∼60% had at least a 30% reduction in PTH from baseline. Serum calcium, phosphorus and the calcium-phosphorus product did not increase during the study. Concomitant vitamin D sterol and phosphate binder therapy remained stable. Cinacalcet was safe and generally well tolerated at doses up to 180 mg/day. Conclusions. In this long-term study, cinacalcet effectively sustained reductions in PTH for up to 3 years without increasing concentrations of serum calcium, phosphorus or calcium-phosphorus product.

Original languageEnglish (US)
Pages (from-to)2186-2193
Number of pages8
JournalNephrology Dialysis Transplantation
Volume20
Issue number10
DOIs
StatePublished - Oct 2005

Keywords

  • Calcium-sensing receptor
  • Chronic kidney disease
  • End-stage renal disease
  • Haemodialysis
  • Parathyroid hormone

ASJC Scopus subject areas

  • Nephrology
  • Transplantation

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