The ADVANCE study: a randomized study to evaluate the effects of cinacalcet plus low-dose vitamin D on vascular calcification in patients on hemodialysis
Raggi P, Chertow GM, Torres PU, Csiky B, Naso A, Nossuli K, Moustafa M, Goodman WG, Lopez N, Downey G, Dehmel B, Floege J, ADVANCE Study Group
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 393 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2010-12-08 · Nephrol Dial Transplant · vol. 26 · número 4 · págs. 1327–1339
- Editorial
- Oxford University Press
- Citado
- 574 citas · más que el 100% de estudios similares · 29.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 47 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Parathyroid Disorders and Treatments · Vitamin D Research Studies · Dialysis and Renal Disease Management
- Palabras clave
- cinacalcet, low-dose vitamin D, vascular calcification, coronary artery calcification, cardiac valve calcification, aortic valve calcification, secondary hyperparathyroidism, hemodialysis, 1,25-dihydroxyvitamin D3, paricalcitol, phosphate binders, parathyroid hormone
- MeSH
- humans, kidney failure, chronic, calcinosis, hyperparathyroidism, secondary, naphthalenes, vitamins, vitamin d, prognosis, renal dialysis, follow-up studies, prospective studies, dose-response relationship, drug, adult, middle aged, female, male, coronary artery disease, cinacalcet
13 autores
- Paolo Raggi🇺🇸 · autor de correspondenciaEmory University
- Glenn Matthew Chertow🇺🇸Stanford Medicine; Stanford University
- P. U. Torres
- Botond Szabolcs Csiky🇭🇺University of Pecs
- Agostino Naso🇮🇹University of Padua
- K. Nossuli
- M. Moustafa
- William G. Goodman🇺🇸Amgen (United States)
- N. Lopez🇺🇸Amgen (United States)
- Gerry Downey🇬🇧Amgen (United Kingdom)
- Bastian Dehmel🇨🇭Amgen (Switzerland)
- Jürgen Floege🇩🇪RWTH Aachen University
- on behalf of the ADVANCE Study Group
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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