Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

Geoffrey A. Block, Kevin J. Martin, Angel L M De Francisco, Stewart A. Turner, Morrell M. Avram, Michael G. Suranyi, Gavril Hercz, John Cunningham, Ali K. Abu-Alfa, Piergiorgio Messa, Daniel W. Coyne, Francesco Locatelli, Raphael M. Cohen, Pieter Evenepoel, Sharon M. Moe, Albert Fournier, Johann Braun, Laura C. McCary, Valter J. Zani, Kurt A. OlsonTilman B. Drüeke, William G. Goodman

Research output: Contribution to journalArticle

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

Original languageEnglish
Pages (from-to)1516-1525
Number of pages10
JournalNew England Journal of Medicine
Volume350
Issue number15
DOIs
Publication statusPublished - Apr 8 2004

ASJC Scopus subject areas

  • Medicine(all)

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    Block, G. A., Martin, K. J., De Francisco, A. L. M., Turner, S. A., Avram, M. M., Suranyi, M. G., Hercz, G., Cunningham, J., Abu-Alfa, A. K., Messa, P., Coyne, D. W., Locatelli, F., Cohen, R. M., Evenepoel, P., Moe, S. M., Fournier, A., Braun, J., McCary, L. C., Zani, V. J., ... Goodman, W. G. (2004). Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis. New England Journal of Medicine, 350(15), 1516-1525. https://doi.org/10.1056/NEJMoa031633