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Evaluating extended-release calcifediol as a treatment option for chronic kidney disease-mineral and bone disorder (CKD-MBD).
Expert Opin Pharmacother. 2019 Dec; 20(17):2081-2093.EO

Abstract

Introduction: Extended-release calcifediol (ERC) is an orally administered prohormone of active vitamin D (1,25-dihydroxyvitamin D [1,25D]) designed to safely and sufficiently increase serum total 25-hydroxyvitamin D (25D) to reduce elevated parathyroid hormone (PTH) in patients with non-dialysis-chronic kidney disease (ND-CKD). ERC is currently approved in the United States and Canada.Areas covered: Herein, key clinical data relating to the pharmacokinetics, pharmacodynamics, efficacy and safety of ERC are reviewed.Expert opinion: Currently available treatment options for secondary hyperparathyroidism (SHPT) in ND-CKD have limitations: the effectiveness of nutritional vitamin D supplements for reduction of PTH levels is unproven and active (1α-hydroxylated) vitamin D analogues elevate serum calcium, which increases the risk of hypercalcemia and vascular calcification. Clinical studies show that ERC is an effective, well tolerated treatment for SHPT in ND-CKD. ERC gradually raises serum 25D levels, resulting in physiologically regulated increases in serum 1,25D and sustained reductions in PTH, while avoiding clinically meaningful increases in serum phosphorus, calcium and fibroblast growth factor 23. ERC offers a new, effective and well tolerated treatment option for the early management of SHPT in patients with ND-CKD.

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Authors+Show Affiliations

Cozzolino M
Renal Division and Laboratory of Experimental Nephrology, Department of Health Sciences, University of Milan, Milan, Italy.
Ketteler M
Department of General Internal Medicine and Nephrology, Robert-Bosch-Krankenhaus, Stuttgart, Germany. School of Medicine, University of Split, Split, Croatia.

MeSH

CalcifediolCalciumChronic Kidney Disease-Mineral and Bone DisorderClinical Trials as TopicDiarrheaHalf-LifeHumansParathyroid HormoneTreatment Outcome

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

31675257

Citation

Cozzolino, Mario, and Markus Ketteler. "Evaluating Extended-release Calcifediol as a Treatment Option for Chronic Kidney Disease-mineral and Bone Disorder (CKD-MBD)." Expert Opinion On Pharmacotherapy, vol. 20, no. 17, 2019, pp. 2081-2093.
Cozzolino M, Ketteler M. Evaluating extended-release calcifediol as a treatment option for chronic kidney disease-mineral and bone disorder (CKD-MBD). Expert Opin Pharmacother. 2019;20(17):2081-2093.
Cozzolino, M., & Ketteler, M. (2019). Evaluating extended-release calcifediol as a treatment option for chronic kidney disease-mineral and bone disorder (CKD-MBD). Expert Opinion On Pharmacotherapy, 20(17), 2081-2093. https://doi.org/10.1080/14656566.2019.1663826
Cozzolino M, Ketteler M. Evaluating Extended-release Calcifediol as a Treatment Option for Chronic Kidney Disease-mineral and Bone Disorder (CKD-MBD). Expert Opin Pharmacother. 2019;20(17):2081-2093. PubMed PMID: 31675257.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluating extended-release calcifediol as a treatment option for chronic kidney disease-mineral and bone disorder (CKD-MBD). AU - Cozzolino,Mario, AU - Ketteler,Markus, Y1 - 2019/11/01/ PY - 2019/11/2/pubmed PY - 2020/1/8/medline PY - 2019/11/2/entrez KW - 25-hydroxyvitamin D KW - Chronic kidney disease KW - calcifediol KW - parathyroid hormone KW - secondary hyperparathyroidism KW - vitamin D deficiency KW - vitamin D insufficiency SP - 2081 EP - 2093 JF - Expert opinion on pharmacotherapy JO - Expert Opin Pharmacother VL - 20 IS - 17 N2 - Introduction: Extended-release calcifediol (ERC) is an orally administered prohormone of active vitamin D (1,25-dihydroxyvitamin D [1,25D]) designed to safely and sufficiently increase serum total 25-hydroxyvitamin D (25D) to reduce elevated parathyroid hormone (PTH) in patients with non-dialysis-chronic kidney disease (ND-CKD). ERC is currently approved in the United States and Canada.Areas covered: Herein, key clinical data relating to the pharmacokinetics, pharmacodynamics, efficacy and safety of ERC are reviewed.Expert opinion: Currently available treatment options for secondary hyperparathyroidism (SHPT) in ND-CKD have limitations: the effectiveness of nutritional vitamin D supplements for reduction of PTH levels is unproven and active (1α-hydroxylated) vitamin D analogues elevate serum calcium, which increases the risk of hypercalcemia and vascular calcification. Clinical studies show that ERC is an effective, well tolerated treatment for SHPT in ND-CKD. ERC gradually raises serum 25D levels, resulting in physiologically regulated increases in serum 1,25D and sustained reductions in PTH, while avoiding clinically meaningful increases in serum phosphorus, calcium and fibroblast growth factor 23. ERC offers a new, effective and well tolerated treatment option for the early management of SHPT in patients with ND-CKD. SN - 1744-7666 UR - https://www.unboundmedicine.com/medline/citation/31675257/Evaluating_extended_release_calcifediol_as_a_treatment_option_for_chronic_kidney_disease_mineral_and_bone_disorder__CKD_MBD__ L2 - https://www.tandfonline.com/doi/full/10.1080/14656566.2019.1663826 DB - PRIME DP - Unbound Medicine ER -