Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study.
Management of secondary hyperparathyroidism is challenging with traditional therapy. The calcimimetic cinacalcet HCl acts on the calcium-sensing receptor to increase its sensitivity to calcium, thereby reducing parathyroid hormone (PTH) secretion. This phase 3, multicenter, randomized, placebo-controlled, double-blind study evaluated the efficacy and safety of cinacalcet in hemodialysis (HD) and peritoneal dialysis (PD) patients with PTH > or =300 pg/ml despite traditional therapy. A total of 395 patients received once-daily oral cinacalcet (260 HD, 34 PD) or placebo (89 HD, 12 PD) titrated from 30 to 180 mg to achieve a target intact PTH (iPTH) level of < or =250 pg/ml. During a 10-wk efficacy assessment phase, cinacalcet was more effective than control for PTH reduction outcomes, including proportion of patients with mean iPTH levels < or =300 pg/ml (46 versus 9%), proportion of patients with > or =30% reduction in iPTH from baseline (65 versus 13%), and proportion of patients with > or =20, > or =40, or > or =50% reduction from baseline. Cinacalcet had comparable efficacy in HD and PD patients; 50% of PD patients achieved a mean iPTH < or =300 pg/ml. Cinacalcet also significantly reduced serum calcium, phosphorus, and Ca x P levels compared with control treatment. The most common side effects, nausea and vomiting, were usually mild to moderate in severity and transient. Once-daily oral cinacalcet was effective in rapidly and safely reducing PTH, Ca x P, calcium, and phosphorus levels in patients who received HD or PD. Cinacalcet offers a new therapeutic option for controlling secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
Lindberg
Jill S
JS
New Orleans Nephrology Associates, 4228 Houma Boulevard, Metairie, LA 70006, USA. jlindberg@bellsouth.net
Culleton
Bruce
B
Wong
Gordon
G
Borah
Michael F
MF
Clark
Roderick V
RV
Shapiro
Warren B
WB
Roger
Simon D
SD
Husserl
Fred E
FE
Klassen
Preston S
PS
Guo
Matthew D
MD
Albizem
Moetaz B
MB
Coburn
Jack W
JW
D000284:Administration, Oral; D000328:Adult; D002118:Calcium / Q000097:blood; D000069449:Cinacalcet; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000008:administration & dosage*; D010281:Parathyroid Hormone / Q000097:blood; D010530:Peritoneal Dialysis; D010758:Phosphorus / Q000097:blood; D006435:Renal Dialysis; D014807:Vitamin D / Q000008:administration & dosage
D009281:Naphthalenes; D010281:Parathyroid Hormone; D014807:Vitamin D; D010758:Phosphorus; D002118:Calcium; D000069449:Cinacalcet