title: A prospective randomized pilot study on intermittent post-dialysis dosing of cinacalcet.
abstract: BACKGROUND
  Treatment of secondary hyperparathyroidism (SHPT) is important in management of patients with end-stage renal disease on hemodialysis (HD). Calcimimetic agent, cinacalcet provides an option for control of SHPT in patients who fail traditional therapy. It may not have optimal results in non-compliant patients. To enhance compliance, we evaluated effectiveness of post-dialysis dosing of cinacalcet (group AD) as compared to daily home administration (group D) in a prospective randomized trial of HD patients with refractory SHPT.
  
  
  METHODS
  After 2-week run-in phase, patients were randomly assigned to two treatment groups. In group AD (N = 12), patients were administered cinacalcet on the day of dialysis (3 times/week) by dialysis staff, while in control group D (N = 11), cinacalcet was prescribed daily to be taken by patients at home. Intact parathyroid hormone (i-PTH), serum calcium, phosphorus, and alkaline phosphatase were followed for 16 weeks and compared to baseline in both groups. Data were analyzed using between-groups linear regression for repeated measures.
  
  
  RESULTS
  No significant decline in i-PTH occurred in group AD at 16 weeks as compared to a significant drop in group D (p = 0.006). However, subgroup analysis showed effectiveness of post-dialysis dosing in patients with less severe SHPT (p = 0.04).
  
  
  CONCLUSIONS
  Although daily dosing overall was more effective for treatment of SHPT, dialysis dosing was effective in patients with less severe SHPT. This warrants a larger study considering the limitations of this pilot trial. In the meantime, dialysis dosing can be considered in non-compliant patients with less severe SHPT.
authors.affiliation: Tawam Hospital in Affiliation with Johns Hopkins, Al Ain, Abu Dhabhi, United Arab Emirates, nulhaq@kfshrc.edu.sa.
authors.forename: Naveed
authors.initials: N
authors.lastname: Haq
authors.forename: Ahmed
authors.initials: A
authors.lastname: Chaaban
authors.forename: Nicole
authors.initials: N
authors.lastname: Gebran
authors.forename: Imran
authors.initials: I
authors.lastname: Khan
authors.forename: Fayez
authors.initials: F
authors.lastname: Abbachi
authors.forename: Muhyeddin
authors.initials: M
authors.lastname: Hassan
authors.forename: Roos
authors.initials: R
authors.lastname: Bernsen
authors.forename: Samra
authors.initials: S
authors.lastname: Abouchacra
mesh_terms: D000328:Adult; D000368:Aged; D000469:Alkaline Phosphatase / Q000097:blood; D057966:Calcimimetic Agents / Q000008:administration & dosage*; D002118:Calcium / Q000097:blood; D000069449:Cinacalcet; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy*; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D009281:Naphthalenes / Q000008:administration & dosage*; D010281:Parathyroid Hormone / Q000097:blood; D010758:Phosphorus / Q000097:blood; D010865:Pilot Projects; D011446:Prospective Studies; D006435:Renal Dialysis; D012720:Severity of Illness Index
chemical_list: D057966:Calcimimetic Agents; D009281:Naphthalenes; D010281:Parathyroid Hormone; D010758:Phosphorus; D000469:Alkaline Phosphatase; D002118:Calcium; D000069449:Cinacalcet