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

Nephrol Dial Transplant. 2005 Oct;20(10):2186-93. doi: 10.1093/ndt/gfh966. Epub 2005 Jul 19.

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 > or =300 pg/ml] who were enrolled in one of four phase 2 placebo-controlled studies were eligible to enroll 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 < or =300 pg/ml at the week-100 study visit, and approximately 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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Calcium / blood
  • Cinacalcet
  • Female
  • Humans
  • Hyperparathyroidism, Secondary / blood
  • Hyperparathyroidism, Secondary / drug therapy*
  • Hyperparathyroidism, Secondary / etiology
  • Kidney Failure, Chronic / complications
  • Male
  • Middle Aged
  • Naphthalenes / adverse effects
  • Naphthalenes / therapeutic use*
  • Parathyroid Hormone / blood
  • Phosphorus / blood
  • Receptors, Calcium-Sensing / drug effects
  • Receptors, Calcium-Sensing / metabolism
  • Time Factors

Substances

  • Naphthalenes
  • Parathyroid Hormone
  • Receptors, Calcium-Sensing
  • Phosphorus
  • Calcium
  • Cinacalcet