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Original Article
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Volume 350:1516-1525 April 8, 2004 Number 15
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Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
Geoffrey A. Block, M.D., Kevin J. Martin, M.B., B.Ch., Angel L.M. de Francisco, M.D., Stewart A. Turner, Ph.D., Morrell M. Avram, M.D., Michael G. Suranyi, M.D., Gavril Hercz, M.D., John Cunningham, D.M., Ali K. Abu-Alfa, M.D., Piergiorgio Messa, M.D., Daniel W. Coyne, M.D., Francesco Locatelli, M.D., Raphael M. Cohen, M.D., Pieter Evenepoel, M.D., Sharon M. Moe, M.D., Albert Fournier, M.D., Johann Braun, M.D., Laura C. McCary, Ph.D., Valter J. Zani, Ph.D., Kurt A. Olson, M.S., Tilman B. Drüeke, M.D., and William G. Goodman, M.D.

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ABSTRACT

Background Treatment of secondary hyperparathyroidism with vitamin D and calcium in patients receiving dialysis is often complicated by hypercalcemia and hyperphosphatemia, which may contribute to cardiovascular disease and adverse clinical outcomes. Calcimimetics target the calcium-sensing receptor and lower parathyroid hormone levels without increasing calcium and phosphorus levels. We report the results of two identical randomized, double-blind, placebo-controlled trials evaluating the safety and effectiveness of the calcimimetic agent cinacalcet hydrochloride.

Methods Patients who were receiving hemodialysis and who had inadequately controlled secondary hyperparathyroidism despite standard treatment were randomly assigned to receive cinacalcet (371 patients) or placebo (370 patients) for 26 weeks. Once-daily doses were increased from 30 mg to 180 mg to achieve intact parathyroid hormone levels of 250 pg per milliliter or less. The primary end point was the percentage of patients with values in this range during a 14-week efficacy-assessment phase.

Results Forty-three percent of the cinacalcet group reached the primary end point, as compared with 5 percent of the placebo group (P<0.001). Overall, mean parathyroid hormone values decreased 43 percent in those receiving cinacalcet but increased 9 percent in the placebo group (P<0.001). The serum calcium–phosphorus product declined by 15 percent in the cinacalcet group and remained unchanged in the placebo group (P<0.001). Cinacalcet effectively reduced parathyroid hormone levels independently of disease severity or changes in vitamin D sterol dose.

Conclusions Cinacalcet lowers parathyroid hormone levels and improves calcium–phosphorus homeostasis in patients receiving hemodialysis who have uncontrolled secondary hyperparathyroidism.


Source Information

From Denver Nephrologists, Denver (G.A.B.); Saint Louis University, St. Louis (K.J.M.); Hospital Marqués de Valdecilla, Santander, Spain (A.L.M.F.); Amgen, Thousand Oaks, Calif. (S.A.T., L.C.M., V.J.Z., K.A.O.); Long Island College Hospital, Brooklyn, N.Y. (M.M.A.); Liverpool Hospital, Liverpool, NSW, Australia (M.G.S.); Humber River Regional Hospital, Toronto (G.H.); University College London Hospitals, London (J.C.); Yale University School of Medicine, New Haven, Conn. (A.K.A.-A.); Ospedale Civile S. Andrea, La Spezia, Italy (P.M.); Washington University School of Medicine, St. Louis (D.W.C.); Ospedale Manzoni, Lecco, Italy (F.L.); Presbyterian Medical Center, Philadelphia (R.M.C.); Universitaire Ziekenhuis Gasthuisberg, Leuven, Belgium (P.E.); Indiana University School of Medicine, Indianapolis (S.M.M.); Centre Hospitalier Universitaire d'Amiens, Amiens, France (A.F.); Kuratorium für Dialyse, Nuremberg, Germany (J.B.); Necker Hospital, Paris (T.B.D.); and UCLA School of Medicine, Los Angeles (W.G.G.).

Address reprint requests to Dr. Block at Denver Nephrologists, 1601 E. 19th Ave. #4300, Denver, CO 80218, or at gablock{at}denverneph.net.

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Related Letters:

Cinacalcet for Secondary Hyperparathyroidism in Hemodialysis Recipients
Owda A. K., Alam M. G., Kumar J., Ureña Torres P. A., Chanard J., Block G. A., Goodman W. G.
Extract | Full Text | PDF  
N Engl J Med 2004; 351:188-189, Jul 8, 2004. Correspondence

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