The ADVANCE study: A randomized study to evaluate the effects of cinacalcet plus low-dose vitamin D on vascular calcification in patients on hemodialysis

作者：Raggi P^*; Chertow G M; Torres P U; Csiky B; Naso A; Nossuli K; Moustafa M; Goodman W G; Lopez N; Downey G; Dehmel B; Floege J

来源：Nephrology Dialysis Transplantation, 2011, 26(4): 1327-1339.

DOI：10.1093/ndt/gfq725

• calcification
• cinacalcet
• hemodialysis
• secondary hyperparathyroidism
• vitamin D

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 150300 pg/mL with calciumphosphorus product > 50 mg2/dL2 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 (30180 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.

• 单位
  University of Pecs; University of Padova