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Modified-release calcifediol effectively controls secondary hyperparathyroidism associated with vitamin D insufficiency in chronic kidney disease.
Am J Nephrol. 2014; 40(6):535-45.AJ

Abstract

BACKGROUND/AIMS

Vitamin D insufficiency drives secondary hyperparathyroidism (SHPT) and is associated with increased cardiovascular mortality in patients with chronic kidney disease (CKD). SHPT is poorly addressed by current vitamin D repletion options. The present study evaluated a novel investigational vitamin D repletion therapy: a modified-release (MR) formulation of calcifediol designed to raise serum 25-hydroxyvitamin D in a gradual manner to minimize the induction of CYP24 and, thereby, improve the SHPT control.

METHODS

This randomized, double-blind, placebo-controlled trial evaluated MR calcifediol in CKD subjects (n = 78) with plasma intact parathyroid hormone (iPTH) >70 pg/ml and serum total 25-hydroxyvitamin D <30 ng/ml. Subjects received daily treatment for six weeks with oral MR calcifediol (30, 60 or 90 µg) or a placebo.

RESULTS

More than 90% of subjects treated with MR calcifediol achieved serum 25-hydroxyvitamin D levels ≥30 ng/ml versus 3% of subjects treated with placebo (p < 0.0001). Mean plasma iPTH decreased from baseline (140.3 pg/ml) by 20.9 ± 6.2% (SE), 32.8 ± 5.7 and 39.3 ± 4.3% in the 30, 60 and 90 µg dose groups, respectively, and increased 17.2 ± 7.8% in the pooled placebo group (p < 0.005). No clinically significant safety concerns arose during MR calcifediol treatment.

CONCLUSION

Oral MR calcifediol appears safe and highly effective in treating SHPT associated with vitamin D insufficiency in CKD.

Authors+Show Affiliations

NorthShore University Health System-University of Chicago, Pritzker School of Medicine, Evanston, Ill., USA.No 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

25572630

Citation

Sprague, Stuart M., et al. "Modified-release Calcifediol Effectively Controls Secondary Hyperparathyroidism Associated With Vitamin D Insufficiency in Chronic Kidney Disease." American Journal of Nephrology, vol. 40, no. 6, 2014, pp. 535-45.
Sprague SM, Silva AL, Al-Saghir F, et al. Modified-release calcifediol effectively controls secondary hyperparathyroidism associated with vitamin D insufficiency in chronic kidney disease. Am J Nephrol. 2014;40(6):535-45.
Sprague, S. M., Silva, A. L., Al-Saghir, F., Damle, R., Tabash, S. P., Petkovich, M., Messner, E. J., White, J. A., Melnick, J. Z., & Bishop, C. W. (2014). Modified-release calcifediol effectively controls secondary hyperparathyroidism associated with vitamin D insufficiency in chronic kidney disease. American Journal of Nephrology, 40(6), 535-45. https://doi.org/10.1159/000369939
Sprague SM, et al. Modified-release Calcifediol Effectively Controls Secondary Hyperparathyroidism Associated With Vitamin D Insufficiency in Chronic Kidney Disease. Am J Nephrol. 2014;40(6):535-45. PubMed PMID: 25572630.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Modified-release calcifediol effectively controls secondary hyperparathyroidism associated with vitamin D insufficiency in chronic kidney disease. AU - Sprague,Stuart M, AU - Silva,Arnold L, AU - Al-Saghir,Fahd, AU - Damle,Radhika, AU - Tabash,Samir P, AU - Petkovich,Martin, AU - Messner,Eric J, AU - White,Jay A, AU - Melnick,Joel Z, AU - Bishop,Charles W, Y1 - 2015/01/07/ PY - 2014/07/20/received PY - 2014/11/13/accepted PY - 2015/1/10/entrez PY - 2015/1/13/pubmed PY - 2015/9/25/medline SP - 535 EP - 45 JF - American journal of nephrology JO - Am J Nephrol VL - 40 IS - 6 N2 - BACKGROUND/AIMS: Vitamin D insufficiency drives secondary hyperparathyroidism (SHPT) and is associated with increased cardiovascular mortality in patients with chronic kidney disease (CKD). SHPT is poorly addressed by current vitamin D repletion options. The present study evaluated a novel investigational vitamin D repletion therapy: a modified-release (MR) formulation of calcifediol designed to raise serum 25-hydroxyvitamin D in a gradual manner to minimize the induction of CYP24 and, thereby, improve the SHPT control. METHODS: This randomized, double-blind, placebo-controlled trial evaluated MR calcifediol in CKD subjects (n = 78) with plasma intact parathyroid hormone (iPTH) >70 pg/ml and serum total 25-hydroxyvitamin D <30 ng/ml. Subjects received daily treatment for six weeks with oral MR calcifediol (30, 60 or 90 µg) or a placebo. RESULTS: More than 90% of subjects treated with MR calcifediol achieved serum 25-hydroxyvitamin D levels ≥30 ng/ml versus 3% of subjects treated with placebo (p < 0.0001). Mean plasma iPTH decreased from baseline (140.3 pg/ml) by 20.9 ± 6.2% (SE), 32.8 ± 5.7 and 39.3 ± 4.3% in the 30, 60 and 90 µg dose groups, respectively, and increased 17.2 ± 7.8% in the pooled placebo group (p < 0.005). No clinically significant safety concerns arose during MR calcifediol treatment. CONCLUSION: Oral MR calcifediol appears safe and highly effective in treating SHPT associated with vitamin D insufficiency in CKD. SN - 1421-9670 UR - https://www.unboundmedicine.com/medline/citation/25572630/Modified_release_calcifediol_effectively_controls_secondary_hyperparathyroidism_associated_with_vitamin_D_insufficiency_in_chronic_kidney_disease_ L2 - https://www.karger.com?DOI=10.1159/000369939 DB - PRIME DP - Unbound Medicine ER -