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.
Background Treatment of secondary hyperparathyroidism with vitaminD and calcium in patients receiving dialysis is often complicatedby hypercalcemia and hyperphosphatemia, which may contributeto cardiovascular disease and adverse clinical outcomes. Calcimimeticstarget the calcium-sensing receptor and lower parathyroid hormonelevels without increasing calcium and phosphorus levels. Wereport the results of two identical randomized, double-blind,placebo-controlled trials evaluating the safety and effectivenessof the calcimimetic agent cinacalcet hydrochloride.
Methods Patients who were receiving hemodialysis and who hadinadequately controlled secondary hyperparathyroidism despitestandard treatment were randomly assigned to receive cinacalcet(371 patients) or placebo (370 patients) for 26 weeks. Once-dailydoses were increased from 30 mg to 180 mg to achieve intactparathyroid hormone levels of 250 pg per milliliter or less.The primary end point was the percentage of patients with valuesin this range during a 14-week efficacy-assessment phase.
Results Forty-three percent of the cinacalcet group reachedthe primary end point, as compared with 5 percent of the placebogroup (P<0.001). Overall, mean parathyroid hormone valuesdecreased 43 percent in those receiving cinacalcet but increased9 percent in the placebo group (P<0.001). The serum calcium–phosphorusproduct declined by 15 percent in the cinacalcet group and remainedunchanged in the placebo group (P<0.001). Cinacalcet effectivelyreduced parathyroid hormone levels independently of diseaseseverity or changes in vitamin D sterol dose.
Conclusions Cinacalcet lowers parathyroid hormone levels andimproves calcium–phosphorus homeostasis in patients receivinghemodialysis 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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