title: Simultaneous control of PTH and CaxP Is sustained over three years of treatment with cinacalcet HCl.
abstract: 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.
authors.affiliation: Evanston Northwestern Healthcare and Northwestern University Feinberg School of Medicine, Evanston, IL 60201, USA. ssprague@northwestern.edu
authors.forename: Stuart M
authors.initials: SM
authors.lastname: Sprague
authors.forename: Pieter
authors.initials: P
authors.lastname: Evenepoel
authors.forename: Mario P
authors.initials: MP
authors.lastname: Curzi
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: González
authors.forename: Fred E
authors.initials: FE
authors.lastname: Husserl
authors.forename: Nelson
authors.initials: N
authors.lastname: Kopyt
authors.forename: Lulu Ren
authors.initials: LR
authors.lastname: Sterling
authors.forename: Chris
authors.initials: C
authors.lastname: Mix
authors.forename: Gordon
authors.initials: G
authors.lastname: Wong
mesh_terms: 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
chemical_list: 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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