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Protocol adherence and the progression of cardiovascular calcification in the ADVANCE study.
Nephrol Dial Transplant. 2013 Jan; 28(1):146-52.ND

Abstract

BACKGROUND

The ADVANCE study assessed the progression of vascular and cardiac valve calcification in 360 hemodialysis patients with secondary hyperparathyroidism (sHPT) assigned randomly to treatment either with cinacalcet plus low-dose vitamin D (≤ 6 µg/week of intravenous paricalcitol equivalent) or with varying doses of vitamin D alone for 52 weeks. The primary efficacy endpoint was progression of coronary artery calcification (CAC).

METHODS

In this post-hoc analysis, we compared CAC progression among 70 protocol-adherent subjects given cinacalcet and low doses of vitamin D (CPA) as specified in the study protocol and 120 control subjects given vitamin D sterols.

RESULTS

Baseline patient characteristics did not differ between CPA and control subjects. The mean (standard error of the mean, SEM) doses of vitamin D at week 2 were 4.7 (0.3) and 12.8 (1.0) µg/week in CPA and control subjects, respectively, and the corresponding mean cumulative doses of vitamin D over 52 weeks in each group were 225 (22) and 671 (47) µg. The median change in Agatston CAC score after 52 weeks was less in CPA subjects than in controls (17.8% versus 31.3%, P = 0.02). The median increase in calcification scores in the aortic valve also was less in CPA subjects than in controls (6.0% versus 51.5% P = 0.02). Reductions in serum parathyroid hormone, calcium and phosphorus levels were significantly greater in CPA subjects than in controls (P < 0.05).

CONCLUSIONS

The progression of cardiovascular calcification was attenuated among cinacalcet-treated subjects with sHPT given low doses of vitamin D per protocol compared with control subjects in whom sHPT was treated with higher doses of vitamin D sterols alone.

Authors+Show Affiliations

Clinique du Landy, Saint Ouen, France. pablo.urena@wanadoo.frNo 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

Language

eng

PubMed ID

23028103

Citation

Ureña-Torres, Pablo A., et al. "Protocol Adherence and the Progression of Cardiovascular Calcification in the ADVANCE Study." Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, vol. 28, no. 1, 2013, pp. 146-52.
Ureña-Torres PA, Floege J, Hawley CM, et al. Protocol adherence and the progression of cardiovascular calcification in the ADVANCE study. Nephrol Dial Transplant. 2013;28(1):146-52.
Ureña-Torres, P. A., Floege, J., Hawley, C. M., Pedagogos, E., Goodman, W. G., Pétavy, F., Reiner, M., & Raggi, P. (2013). Protocol adherence and the progression of cardiovascular calcification in the ADVANCE study. Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, 28(1), 146-52. https://doi.org/10.1093/ndt/gfs356
Ureña-Torres PA, et al. Protocol Adherence and the Progression of Cardiovascular Calcification in the ADVANCE Study. Nephrol Dial Transplant. 2013;28(1):146-52. PubMed PMID: 23028103.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Protocol adherence and the progression of cardiovascular calcification in the ADVANCE study. AU - Ureña-Torres,Pablo A, AU - Floege,Jürgen, AU - Hawley,Carmel M, AU - Pedagogos,Eugenie, AU - Goodman,William G, AU - Pétavy,Frank, AU - Reiner,Maureen, AU - Raggi,Paolo, Y1 - 2012/09/30/ PY - 2012/10/3/entrez PY - 2012/10/3/pubmed PY - 2013/7/3/medline SP - 146 EP - 52 JF - Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association JO - Nephrol Dial Transplant VL - 28 IS - 1 N2 - BACKGROUND: The ADVANCE study assessed the progression of vascular and cardiac valve calcification in 360 hemodialysis patients with secondary hyperparathyroidism (sHPT) assigned randomly to treatment either with cinacalcet plus low-dose vitamin D (≤ 6 µg/week of intravenous paricalcitol equivalent) or with varying doses of vitamin D alone for 52 weeks. The primary efficacy endpoint was progression of coronary artery calcification (CAC). METHODS: In this post-hoc analysis, we compared CAC progression among 70 protocol-adherent subjects given cinacalcet and low doses of vitamin D (CPA) as specified in the study protocol and 120 control subjects given vitamin D sterols. RESULTS: Baseline patient characteristics did not differ between CPA and control subjects. The mean (standard error of the mean, SEM) doses of vitamin D at week 2 were 4.7 (0.3) and 12.8 (1.0) µg/week in CPA and control subjects, respectively, and the corresponding mean cumulative doses of vitamin D over 52 weeks in each group were 225 (22) and 671 (47) µg. The median change in Agatston CAC score after 52 weeks was less in CPA subjects than in controls (17.8% versus 31.3%, P = 0.02). The median increase in calcification scores in the aortic valve also was less in CPA subjects than in controls (6.0% versus 51.5% P = 0.02). Reductions in serum parathyroid hormone, calcium and phosphorus levels were significantly greater in CPA subjects than in controls (P < 0.05). CONCLUSIONS: The progression of cardiovascular calcification was attenuated among cinacalcet-treated subjects with sHPT given low doses of vitamin D per protocol compared with control subjects in whom sHPT was treated with higher doses of vitamin D sterols alone. SN - 1460-2385 UR - https://www.unboundmedicine.com/medline/citation/23028103/Protocol_adherence_and_the_progression_of_cardiovascular_calcification_in_the_ADVANCE_study_ L2 - https://academic.oup.com/ndt/article-lookup/doi/10.1093/ndt/gfs356 DB - PRIME DP - Unbound Medicine ER -