Simultaneous control of PTH and CaxP Is sustained over three years of treatment with cinacalcet HCl.
OBJECTIVE
Chronic kidney disease (CKD) is commonly complicated by secondary hyperparathyroidism (SHPT), leading to increased risk of morbidity and mortality. SHPT is a progressive disease often requiring long-term therapy to control parathyroid hormone (PTH) and mineral imbalances. Vitamin D sterols and phosphate binders, used as traditional therapies to lower PTH and phosphorus, may provide inadequate long-term control for many dialysis patients. Cinacalcet, by simultaneously lowering PTH, calcium, phosphorus, and calcium-phosphorus levels, may maintain PTH and mineral balance in these individuals. However, as with traditional therapies, long-term data are limited. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENT: Dialysis subjects from at least one of five lead-in studies (double-blind placebo-controlled, including one extension trial) completing up to 52 wk of either cinacalcet or placebo were eligible for this open-label extension study, including an 8-wk dose titration (initiated at 30 mg/d), followed by 24-wk maintenance and up to 132 wk of follow-up. Final efficacy analysis was at week 180.


RESULTS
Three hundred thirty-four of 589 enrolled subjects received cinacalcet from the beginning of the lead-in study. Weekly median PTH values were < or =300 pg/ml (weeks 16 through 180) and median CaxP values were < or =55 mg(2)/dl(2) (weeks 4 through 180). Similar results were exhibited in the 255 subjects who initially received placebo. Among the patients exposed to cinacalcet from the beginning of the lead-in study, 3% of subjects exhibited treatment-related serious adverse events.


CONCLUSIONS
Cinacalcet effectively maintained PTH, Ca and P reductions in dialysis subjects for up to 180 wk.
Sprague
Stuart M
SM
Evanston Northwestern Healthcare and Northwestern University Feinberg School of Medicine, Evanston, IL 60201, USA. ssprague@northwestern.edu
Evenepoel
Pieter
P
Curzi
Mario P
MP
González
Maria Teresa
MT
Husserl
Fred E
FE
Kopyt
Nelson
N
Sterling
Lulu Ren
LR
Mix
Chris
C
Wong
Gordon
G
D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D002118:Calcium / Q000097:blood*; D002170:Canada; D002614:Chelating Agents / Q000627:therapeutic use; D002908:Chronic Disease; D000069449:Cinacalcet; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005060:Europe; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D007674:Kidney Diseases / Q000097:blood / Q000150:complications / Q000188:drug therapy / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000009:adverse effects / Q000627:therapeutic use*; D010281:Parathyroid Hormone / Q000097:blood*; D010530:Peritoneal Dialysis; D010710:Phosphates / Q000097:blood; D010758:Phosphorus / Q000097:blood*; D006435:Renal Dialysis; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D014807:Vitamin D / Q000627:therapeutic use
D015415:Biomarkers; D002614:Chelating Agents; D009281:Naphthalenes; D010281:Parathyroid Hormone; D010710:Phosphates; D014807:Vitamin D; D010758:Phosphorus; D002118:Calcium; D000069449:Cinacalcet
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