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

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.

• Authors: 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
• Journal: Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association (Nephrol Dial Transplant) Vol. 20 Issue 10 Pg. 2186-93 (Oct 2005) ISSN: 0931-0509 [Print] England
• PMID: 16030053 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)

Chemical References

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

Topics

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