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Extended-release calcifediol for secondary hyperparathyroidism in stage 3-4 chronic kidney disease.
Expert Rev Endocrinol Metab. 2017 09; 12(5):289-301.ER

Abstract

INTRODUCTION

Extended-release calcifediol (ERC) 30 µg capsules were recently approved as Rayaldee® by the United States Food and Drug Administration (FDA) for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3-4 (not 5) chronic kidney disease (CKD) and vitamin D insufficiency (serum total 25-hydroxyvitamin D < 30 ng/mL). Calcifediol is 25-hydroxyvitamin D3, a prohormone of calcitriol (1,25-dihydroxyvitamin D3), the endogenous active vitamin D hormone. ERC capsules have a lipophilic fill which gradually releases calcifediol, corrects vitamin D insufficiency and increases serum calcitriol and thereby suppresses production of parathyroid hormone (PTH) in CKD patients without perturbing normal vitamin D and mineral metabolism. Areas covered: This review focuses on the chemical, pharmacokinetic, pharmacodynamic and clinical profiles of ERC and describes the product's utility relative to other current treatment options for SHPT. Expert commentary: Randomized clinical trials (RCTs) have demonstrated that nutritional vitamin D is ineffective for treating SHPT whereas vitamin D receptor activators can correct elevated PTH but with increased risk of hypercalcemia and hyperphosphatemia. ERC offers healthcare professionals a new treatment option that has been demonstrated in RCTs to be safe and effective for controlling SHPT without meaningfully increasing serum concentrations of calcium or phosphorus.

Authors+Show Affiliations

a Department of Medicine , NorthShore University HealthSystem , Evanston , IL , USA.b Renal Division , OPKO Health, Inc ., Miami , FL , USA.b Renal Division , OPKO Health, Inc ., Miami , FL , USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30058895

Citation

Sprague, Stuart M., et al. "Extended-release Calcifediol for Secondary Hyperparathyroidism in Stage 3-4 Chronic Kidney Disease." Expert Review of Endocrinology & Metabolism, vol. 12, no. 5, 2017, pp. 289-301.
Sprague SM, Strugnell SA, Bishop CW. Extended-release calcifediol for secondary hyperparathyroidism in stage 3-4 chronic kidney disease. Expert Rev Endocrinol Metab. 2017;12(5):289-301.
Sprague, S. M., Strugnell, S. A., & Bishop, C. W. (2017). Extended-release calcifediol for secondary hyperparathyroidism in stage 3-4 chronic kidney disease. Expert Review of Endocrinology & Metabolism, 12(5), 289-301. https://doi.org/10.1080/17446651.2017.1347501
Sprague SM, Strugnell SA, Bishop CW. Extended-release Calcifediol for Secondary Hyperparathyroidism in Stage 3-4 Chronic Kidney Disease. Expert Rev Endocrinol Metab. 2017;12(5):289-301. PubMed PMID: 30058895.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Extended-release calcifediol for secondary hyperparathyroidism in stage 3-4 chronic kidney disease. AU - Sprague,Stuart M, AU - Strugnell,Stephen A, AU - Bishop,Charles W, Y1 - 2017/07/11/ PY - 2018/7/31/entrez PY - 2018/7/31/pubmed PY - 2018/7/31/medline KW - 25-hydroxyvitamin D3 KW - Chronic kidney disease KW - calcifediol KW - parathyroid hormone KW - secondary hyperparathyroidism KW - vitamin D KW - vitamin D insufficiency SP - 289 EP - 301 JF - Expert review of endocrinology & metabolism JO - Expert Rev Endocrinol Metab VL - 12 IS - 5 N2 - INTRODUCTION: Extended-release calcifediol (ERC) 30 µg capsules were recently approved as Rayaldee® by the United States Food and Drug Administration (FDA) for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3-4 (not 5) chronic kidney disease (CKD) and vitamin D insufficiency (serum total 25-hydroxyvitamin D < 30 ng/mL). Calcifediol is 25-hydroxyvitamin D3, a prohormone of calcitriol (1,25-dihydroxyvitamin D3), the endogenous active vitamin D hormone. ERC capsules have a lipophilic fill which gradually releases calcifediol, corrects vitamin D insufficiency and increases serum calcitriol and thereby suppresses production of parathyroid hormone (PTH) in CKD patients without perturbing normal vitamin D and mineral metabolism. Areas covered: This review focuses on the chemical, pharmacokinetic, pharmacodynamic and clinical profiles of ERC and describes the product's utility relative to other current treatment options for SHPT. Expert commentary: Randomized clinical trials (RCTs) have demonstrated that nutritional vitamin D is ineffective for treating SHPT whereas vitamin D receptor activators can correct elevated PTH but with increased risk of hypercalcemia and hyperphosphatemia. ERC offers healthcare professionals a new treatment option that has been demonstrated in RCTs to be safe and effective for controlling SHPT without meaningfully increasing serum concentrations of calcium or phosphorus. SN - 1744-8417 UR - https://www.unboundmedicine.com/medline/citation/30058895/Extended_release_calcifediol_for_secondary_hyperparathyroidism_in_stage_3_4_chronic_kidney_disease_ L2 - https://www.tandfonline.com/doi/full/10.1080/17446651.2017.1347501 DB - PRIME DP - Unbound Medicine ER -
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