title: Comparative cost analysis of management of secondary hyperparathyroidism with paricalcitol or cinacalcet with low-dose vitamin D in hemodialysis patients.
abstract: OBJECTIVE
  The objective of this analysis was to compare costs of paricalcitol or cinacalcet plus low dose vitamin D, and of phosphate binders, in patients in the IMPACT SHPT study; and to extrapolate those to estimate expected annual maintenance costs.
  
  
  METHODS
  IMPACT SHPT was a 28-week, randomized, open-label trial. Subjects from 12 countries received intravenous (IV) or oral paricalcitol, or oral cinacalcet plus fixed IV doxercalciferol or oral alfacalcidol. The primary end-point was the proportion of subjects who achieved a mean intact parathyroid hormone (iPTH) value of 150-300 pg/mL during weeks 21-28 (evaluation period). This study compares the costs of study drugs and phosphate binders among participants during the study and annualized. This analysis includes only those subjects that reached the evaluation period (134 in each group).
  
  
  RESULTS
  The mean total drug costs over the study period were €2606 (SD = €2000) in the paricalcitol group and €3034 (SD = €3006) in the cinacalcet group (difference €428, p = 0.1712). The estimated annualized costs were €5387 (SD = €4139) in the paricalcitol group and €6870 (SD = €6256) in the cinacalcet group (difference €1492, p = 0.0395). In addition, a significantly greater proportion (p = 0.010) of subjects in the paricalcitol arm (56.0%) achieved an iPTH of 150-300 pg/mL during the evaluation period compared to the cinacalcet arm (38.2%).
  
  
  CONCLUSIONS
  This was a secondary analysis of the IMPACT SHPT study which was not designed or powered for costs as an outcome. The dosing of study drugs and phosphate binders in the IMPACT study may not reflect actual practice, and patients were followed for 28 weeks, while the treatment of SHPT is long-term.
  
  
  CONCLUSIONS
  Patients with SHPT requiring hemodialysis who were treated with a paricalcitol-based regimen for iPTH control had lower estimated annual drug costs compared to those treated with cinacalcet plus low-dose vitamin D.
authors.affiliation: Nephrian, Thousand Oaks, CA, USA.
authors.forename: Amit
authors.initials: A
authors.lastname: Sharma
authors.forename: Markus
authors.initials: M
authors.lastname: Ketteler
authors.forename: Thomas S
authors.initials: TS
authors.lastname: Marshall
authors.forename: Samina S
authors.initials: SS
authors.lastname: Khan
authors.forename: Glen T
authors.initials: GT
authors.lastname: Schumock
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000069449:Cinacalcet; D003362:Cost-Benefit Analysis; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D016527:Drug Costs; D004359:Drug Therapy, Combination; D004872:Ergocalciferols / Q000191:economics* / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D017048:Health Care Costs; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000150:complications / Q000188:drug therapy* / Q000191:economics; D007275:Injections, Intravenous; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000191:economics* / Q000627:therapeutic use; D011446:Prospective Studies; D006435:Renal Dialysis / Q000379:methods; D016896:Treatment Outcome; D014807:Vitamin D / Q000627:therapeutic use*
chemical_list: D004872:Ergocalciferols; D009281:Naphthalenes; D014807:Vitamin D; C084656:paricalcitol; D000069449:Cinacalcet