1. Modified-release calcifediol effectively controls secondary hyperparathyroidism associated with vitamin D insufficiency in chronic kidney disease.
- Author
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Sprague SM, Silva AL, Al-Saghir F, Damle R, Tabash SP, Petkovich M, Messner EJ, White JA, Melnick JZ, and Bishop CW
- Subjects
- Adult, Aged, Calcifediol blood, Delayed-Action Preparations, Double-Blind Method, Female, Humans, Hyperparathyroidism, Secondary blood, Hyperparathyroidism, Secondary etiology, Male, Middle Aged, Parathyroid Hormone blood, Renal Insufficiency, Chronic blood, Vitamin D blood, Vitamin D Deficiency blood, Vitamin D Deficiency etiology, Vitamins blood, Calcifediol administration & dosage, Hyperparathyroidism, Secondary drug therapy, Renal Insufficiency, Chronic complications, Vitamin D analogs & derivatives, Vitamin D Deficiency drug therapy, Vitamins administration & dosage
- 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.
- Published
- 2014
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