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Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis.
N Engl J Med. 2004 Apr 08; 350(15):1516-25.NEJM

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.

Authors+Show Affiliations

Denver Nephrologists, Denver, USA. gablock@denverneph.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15071126

Citation

Block, Geoffrey A., et al. "Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis." The New England Journal of Medicine, vol. 350, no. 15, 2004, pp. 1516-25.
Block GA, Martin KJ, de Francisco AL, et al. Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis. N Engl J Med. 2004;350(15):1516-25.
Block, G. A., Martin, K. J., de Francisco, A. L., 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. The New England Journal of Medicine, 350(15), 1516-25.
Block GA, et al. Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis. N Engl J Med. 2004 Apr 8;350(15):1516-25. PubMed PMID: 15071126.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR 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 M, 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 - 2004/4/9/pubmed PY - 2004/4/24/medline PY - 2004/4/9/entrez SP - 1516 EP - 25 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 350 IS - 15 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. SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/15071126/Cinacalcet_for_secondary_hyperparathyroidism_in_patients_receiving_hemodialysis_ L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa031633?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -