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 Moe, Albert Fournier, Johann Braun, Laura C. McCary, Valter J. Zani, Kurt A. OlsonTilman B. Drüeke, William G. Goodman

Research output: Contribution to journalArticle

859 Citations (Scopus)

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.

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

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Secondary Hyperparathyroidism
Renal Dialysis
Parathyroid Hormone
Placebos
Phosphorus
Calcium
Vitamin D
Calcimimetic Agents
Hyperphosphatemia
Calcium-Sensing Receptors
Hypercalcemia
Sterols
Cinacalcet Hydrochloride
Dialysis
Homeostasis
Cardiovascular Diseases
Safety
Therapeutics
Serum

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Block, G. A., Martin, K. J., De Francisco, A. L. M., Turner, S. A., Avram, M. M., Suranyi, M. G., ... 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

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

In: New England Journal of Medicine, Vol. 350, No. 15, 08.04.2004, p. 1516-1525.

Research output: Contribution to journalArticle

Block, GA, Martin, KJ, De Francisco, ALM, Turner, SA, Avram, MM, Suranyi, MG, Hercz, G, Cunningham, J, Abu-Alfa, AK, Messa, P, Coyne, DW, Locatelli, F, Cohen, RM, Evenepoel, P, Moe, S, Fournier, A, Braun, J, McCary, LC, Zani, VJ, Olson, KA, Drüeke, TB & Goodman, WG 2004, 'Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis', New England Journal of Medicine, vol. 350, no. 15, pp. 1516-1525. https://doi.org/10.1056/NEJMoa031633
Block GA, Martin KJ, De Francisco ALM, Turner SA, Avram MM, Suranyi MG et al. Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis. New England Journal of Medicine. 2004 Apr 8;350(15):1516-1525. https://doi.org/10.1056/NEJMoa031633
Block, Geoffrey A. ; Martin, Kevin J. ; De Francisco, Angel L M ; Turner, Stewart A. ; Avram, Morrell M. ; Suranyi, Michael G. ; Hercz, Gavril ; Cunningham, John ; Abu-Alfa, Ali K. ; Messa, Piergiorgio ; Coyne, Daniel W. ; Locatelli, Francesco ; Cohen, Raphael M. ; Evenepoel, Pieter ; Moe, Sharon ; Fournier, Albert ; Braun, Johann ; McCary, Laura C. ; Zani, Valter J. ; Olson, Kurt A. ; Drüeke, Tilman B. ; Goodman, William G. / Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis. In: New England Journal of Medicine. 2004 ; Vol. 350, No. 15. pp. 1516-1525.
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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.",
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T1 - Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

AU - Block, Geoffrey A.

AU - Martin, Kevin J.

AU - De Francisco, Angel L M

AU - Turner, Stewart A.

AU - Avram, Morrell M.

AU - Suranyi, Michael G.

AU - Hercz, Gavril

AU - Cunningham, John

AU - Abu-Alfa, Ali K.

AU - Messa, Piergiorgio

AU - Coyne, Daniel W.

AU - Locatelli, Francesco

AU - Cohen, Raphael M.

AU - Evenepoel, Pieter

AU - Moe, Sharon

AU - Fournier, Albert

AU - Braun, Johann

AU - McCary, Laura C.

AU - Zani, Valter J.

AU - Olson, Kurt A.

AU - Drüeke, Tilman B.

AU - Goodman, William G.

PY - 2004/4/8

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N2 - 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.

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