title: The ADVANCE study: a randomized study to evaluate the effects of cinacalcet plus low-dose vitamin D on vascular calcification in patients on hemodialysis.
abstract: BACKGROUND
  This prospective, randomized, controlled trial compared the progression of vascular and cardiac valve calcification in 360 prevalent adult hemodialysis patients with secondary hyperparathyroidism treated with either cinacalcet plus low-dose vitamin D sterols or flexible doses of vitamin D sterols alone.
  
  
  METHODS
  Eligible subjects were on hemodialysis for ≥ 3 months with parathyroid hormone (PTH) > 300 pg/mL or PTH 150-300 pg/mL with calcium-phosphorus product > 50 mg(2)/dL(2) while receiving vitamin D. All subjects received calcium-based phosphate binders. Coronary artery calcification (CAC) and aorta and cardiac valve calcium scores were determined both by Agatston and volume scoring using multi-detector computed tomography. Subjects with Agatston CAC scores ≥ 30 were randomized to cinacalcet (30- 180 mg/day) plus low-dose calcitriol or vitamin D analog (≤ 2 μg paricalcitol equivalent/dialysis), or flexible vitamin D therapy. The primary end point was percentage change in Agatston CAC score from baseline to Week 52.
  
  
  RESULTS
  Median (P10, P90) Agatston CAC scores increased 24% (-22%, 119%) in the cinacalcet group and 31% (-9%, 179%) in the flexible vitamin D group (P = 0.073). Corresponding changes in volume CAC scores were 22% (-12%, 105%) and 30% (-6%, 133%; P = 0.009). Increases in calcification scores were consistently less in the aorta, aortic valve and mitral valve among subjects treated with cinacalcet plus low-dose vitamin D sterols, and the differences between groups were significant at the aortic valve.
  
  
  CONCLUSIONS
  In hemodialysis patients with moderate to severe secondary hyperparathyroidism, cinacalcet plus low-dose vitamin D sterols may attenuate vascular and cardiac valve calcification.
authors.affiliation: Division of Cardiology, Emory University, Atlanta, GA, USA. praggi@emory.edu
authors.forename: Paolo
authors.initials: P
authors.lastname: Raggi
authors.forename: Glenn M
authors.initials: GM
authors.lastname: Chertow
authors.forename: Pablo Urena
authors.initials: PU
authors.lastname: Torres
authors.forename: Botond
authors.initials: B
authors.lastname: Csiky
authors.forename: Agostino
authors.initials: A
authors.lastname: Naso
authors.forename: Kaldun
authors.initials: K
authors.lastname: Nossuli
authors.forename: Moustafa
authors.initials: M
authors.lastname: Moustafa
authors.forename: William G
authors.initials: WG
authors.lastname: Goodman
authors.forename: Nicole
authors.initials: N
authors.lastname: Lopez
authors.forename: Gerry
authors.initials: G
authors.lastname: Downey
authors.forename: Bastian
authors.initials: B
authors.lastname: Dehmel
authors.forename: Jürgen
authors.initials: J
authors.lastname: Floege
mesh_terms: D000328:Adult; D002114:Calcinosis / Q000188:drug therapy* / Q000209:etiology; D000069449:Cinacalcet; D003324:Coronary Artery Disease / Q000188:drug therapy* / Q000209:etiology; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000188:drug therapy* / Q000209:etiology; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000627:therapeutic use*; D011379:Prognosis; D011446:Prospective Studies; D006435:Renal Dialysis; D014807:Vitamin D / Q000627:therapeutic use*; D014815:Vitamins / Q000627:therapeutic use
chemical_list: D009281:Naphthalenes; D014815:Vitamins; D014807:Vitamin D; D000069449:Cinacalcet