title: Cinacalcet hydrochloride (Sensipar) in hemodialysis patients on active vitamin D derivatives with controlled PTH and elevated calcium x phosphate.
abstract: Active vitamin D derivatives attenuate the severity of secondary hyperparathyroidism but often increase serum calcium (Ca) and phosphorus (P) as a result of enhanced intestinal absorption. The calcimimetic cinacalcet HCl lowers parathyroid hormone (PTH) and tends to decrease Ca x P. A 16-wk, open-label clinical trial was conducted in adult hemodialysis patients who had controlled PTH (biointact PTH [biPTH] 80 to 160 pg/ml) and elevated Ca x P (> 55 mg2/dl2) and were receiving paricalcitol > 6 microg/wk (or an equipotent dose of an alternative active vitamin D derivative). At the start of the study, active vitamin D derivatives were decreased to a mean equivalent dose of paricalcitol 6 microg/wk, and cinacalcet was titrated from 30 mg/d to a maximum possible dose of 180 mg/d. Of the 72 study patients, 53 (74%) completed 8 wk of dose titration with cinacalcet. In response to cinacalcet, the following mean percentage changes were observed: biPTH, -1.8%; Ca, -9.7% (P < 0.0001), phosphorus, -11.1% (P < 0.0001), and Ca x P, -20.1% (P < 0.0001). At the end of the study, approximate Kidney Disease Outcomes Quality Initiative targets for biPTH (< or = 160 pg/ml) were achieved in 85% (45 of 53) of patients and for Ca x P (< or = 55 mg2/dl2) in 72% (38 of 53) of patients. Concurrent achievement of both targets occurred in 47% (25 of 53) of patients. In this open-label clinical trial, hemodialysis patients who had controlled PTH but elevated Ca x P and were taking moderate- to high-dose active vitamin D derivatives achieved improved control of mineral metabolism with a combination of low-dose active vitamin D derivatives and cinacalcet. The long-term effects of this treatment regimen on clinical outcomes should be tested prospectively.
authors: Department of Medicine, University of California, San Francisco, School of Medicine, San Francisco, California, USA. chertowg@medicine.ucsf.edu
authors: Glenn M
authors: GM
authors: Chertow
authors: Samuel
authors: S
authors: Blumenthal
authors: Stewart
authors: S
authors: Turner
authors: Michael
authors: M
authors: Roppolo
authors: Leonard
authors: L
authors: Stern
authors: Eric M
authors: EM
authors: Chi
authors: John
authors: J
authors: Reed
mesh_terms: D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D002117:Calcitriol / Q000627:therapeutic use*; D002118:Calcium / Q000097:blood*; D000069449:Cinacalcet; D004872:Ergocalciferols / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000627:therapeutic use*; D010281:Parathyroid Hormone / Q000097:blood*; D010710:Phosphates / Q000097:blood*; D006435:Renal Dialysis
chemical_list: D050071:Bone Density Conservation Agents; D004872:Ergocalciferols; D009281:Naphthalenes; D010281:Parathyroid Hormone; D010710:Phosphates; C042533:1 alpha-hydroxyergocalciferol; C084656:paricalcitol; D002117:Calcitriol; D002118:Calcium; D000069449:Cinacalcet