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NDT Advance Access published online on July 19, 2005
Nephrology Dialysis Transplantation, doi:10.1093/ndt/gfh966
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© The Author [2005]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please email: journals.permissions@oupjournals.org
Received October 22, 2004
Accepted May 25, 2005

Original Articles

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

Sharon M. Moe 1*, John Cunningham 2, Jürgen Bommer 3, Stephen Adler 4, Steven J. Rosansky 5, Pablo Urena-Torres 6, Moetaz B. Albizem 7, Matthew D. Guo 7, Valter J. Zani 7, William G. Goodman 8, and Stuart M. Sprague 9

1 Indiana University School of Medicine and Roudebush VAMC, Indianapolis, IN, USA
2 The Middlesex Hospital, London, UK
3 Klinikum der Universität Heidelberg, Heidelberg, Germany
4 Westchester Medical Center, NY Med College, Valhalla, NY, USA
5 WJB Dorn Veterans Hospital, Columbia, SC, USA
6 Clinique de l'Orangerie, Aubervillers, France
7 Amgen Inc, Thousand Oaks, CA, USA
8 UCLA School of Medicine, Los Angeles, CA, USA
9 Evanston Northwestern Healthcare and Northwestern University Feinberg School of Medicine, Evanston, IL, USA

* To whom correspondence should be addressed.
Sharon M. Moe, E-mail: smoe{at}iupui.edu



  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.

Keywords: calcium-sensing receptor; chronic kidney disease; end-stage renal disease; haemodialysis; parathyroid hormone.
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