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The ADVANCE study: a randomized study to evaluate the effects of cinacalcet plus low-dose vitamin D on vascular calcification in patients on hemodialysis.
Nephrol Dial Transplant. 2011 Apr; 26(4):1327-39.ND

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+Show Affiliations

Division of Cardiology, Emory University, Atlanta, GA, USA. praggi@emory.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21148030

Citation

Raggi, Paolo, et al. "The ADVANCE Study: a Randomized Study to Evaluate the Effects of Cinacalcet Plus Low-dose Vitamin D On Vascular Calcification in Patients On Hemodialysis." Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, vol. 26, no. 4, 2011, pp. 1327-39.
Raggi P, Chertow GM, Torres PU, et al. The ADVANCE study: a randomized study to evaluate the effects of cinacalcet plus low-dose vitamin D on vascular calcification in patients on hemodialysis. Nephrol Dial Transplant. 2011;26(4):1327-39.
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. (2011). The ADVANCE study: a randomized study to evaluate the effects of cinacalcet plus low-dose vitamin D on vascular calcification in patients on hemodialysis. Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, 26(4), 1327-39. https://doi.org/10.1093/ndt/gfq725
Raggi P, et al. The ADVANCE Study: a Randomized Study to Evaluate the Effects of Cinacalcet Plus Low-dose Vitamin D On Vascular Calcification in Patients On Hemodialysis. Nephrol Dial Transplant. 2011;26(4):1327-39. PubMed PMID: 21148030.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The ADVANCE study: a randomized study to evaluate the effects of cinacalcet plus low-dose vitamin D on vascular calcification in patients on hemodialysis. AU - Raggi,Paolo, AU - Chertow,Glenn M, AU - Torres,Pablo Urena, AU - Csiky,Botond, AU - Naso,Agostino, AU - Nossuli,Kaldun, AU - Moustafa,Moustafa, AU - Goodman,William G, AU - Lopez,Nicole, AU - Downey,Gerry, AU - Dehmel,Bastian, AU - Floege,Jürgen, AU - ,, Y1 - 2010/12/08/ PY - 2010/12/15/entrez PY - 2010/12/15/pubmed PY - 2011/9/9/medline SP - 1327 EP - 39 JF - Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association JO - Nephrol Dial Transplant VL - 26 IS - 4 N2 - 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. SN - 1460-2385 UR - https://www.unboundmedicine.com/medline/citation/21148030/The_ADVANCE_study:_a_randomized_study_to_evaluate_the_effects_of_cinacalcet_plus_low_dose_vitamin_D_on_vascular_calcification_in_patients_on_hemodialysis_ L2 - https://academic.oup.com/ndt/article-lookup/doi/10.1093/ndt/gfq725 DB - PRIME DP - Unbound Medicine ER -