Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis.
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.
Block
Geoffrey A
GA
Denver Nephrologists, Denver, USA. gablock@denverneph.net
Martin
Kevin J
KJ
de Francisco
Angel L M
AL
Turner
Stewart A
SA
Avram
Morrell M
MM
Suranyi
Michael G
MG
Hercz
Gavril
G
Cunningham
John
J
Abu-Alfa
Ali K
AK
Messa
Piergiorgio
P
Coyne
Daniel W
DW
Locatelli
Francesco
F
Cohen
Raphael M
RM
Evenepoel
Pieter
P
Moe
Sharon M
SM
Fournier
Albert
A
Braun
Johann
J
McCary
Laura C
LC
Zani
Valter J
VJ
Olson
Kurt A
KA
Drüeke
Tilman B
TB
Goodman
William G
WG
D002118:Calcium / Q000097:blood; D000069449:Cinacalcet; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D007676:Kidney Failure, Chronic / Q000097:blood / Q000150:complications* / Q000628:therapy; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000627:therapeutic use*; D010281:Parathyroid Hormone / Q000097:blood; D010758:Phosphorus / Q000097:blood; D006435:Renal Dialysis
D009281:Naphthalenes; D010281:Parathyroid Hormone; D010758:Phosphorus; D002118:Calcium; D000069449:Cinacalcet