Intermittent doxercalciferol (1 alpha-hydroxyvitamin D-2) therapy for secondary hyperparathyroidism

• Type: Article in International Scientific Journal
• Date: 2000

Authors

João Frazão (Author) FMUP; Elangovan, L (Author) Other; Maung, HM (Author) Other; Chesney, RW (Author) Other; Acchiardo, SR (Author) Other; Bower, JD (Author) Other; Kelley, BJ (Author) Other; Rodriguez, HJ (Author) Other; Norris, KC (Author) Other; Robertson, JA (Author) Other; Levine, BS (Author) Other; Goodman, WG (Author) Other; Gentile, D (Author) Other; Mazess, RB (Author) Other; Kyllo, DM (Author) Other; Douglass, LL (Author) Other; Bishop, CW (Author) Other; Coburn, JW (Author) Other

Journal

Title: American Journal of Kidney Diseases

Vol. 36

Pages: 550-561

ISSN: 0272-6386

Publisher: Elsevier

Indexing

ISI Web of Knowledge - 98 Citations

Scopus - 113 Citations

Other information

Authenticus ID: P-008-PTJ

DOI: 10.1053/ajkd.2000.16193

Abstract (EN): Hypercalcemia and hyperphosphatemia frequently necessitate vitamin D withdrawal in hemodialysis patients with secondary hyperparathyroidism. In short-term trials, doxercalciferol (1 alpha-hydroxyvitamin D-2 [1 alpha D-2]) suppressed intact parathyroid hormone (iPTH) effectively with minimal increases in serum calcium and phosphorus (P) levels. This modified, double-blinded, controlled trial examined the efficacy and safety of 1 alpha D-2 use in 138 hemodialysis patients with moderate to severe secondary hyperparathyroidism by using novel dose titration; 99 patients completed the study. Hemodialysis patients with secondary hyperparathyroidism were enrolled onto this study, consisting of washout (8 weeks), open-label 1 alpha D-2 treatment (16 weeks), and randomized, double-blinded treatment with 1 alpha D-2 or placebo (8 weeks). Oral 1 alpha D-2 was administered at each hemodialysis session, with doses titrated to achieve target iPTH levels of 150 to 300 pg/mL. Baseline iPTH levels (897 +/- 52 [SE] pg/mL) decreased by 20% +/- 3.4% by week 1 (P < 0.001) and by 55% +/- 2.9% at week 16; iPTH levels returned to baseline during placebo treatment but remained suppressed with 1 alpha D-2 treatment. In 80% of the patients, iPTH level decreased by 70%, reaching the target level in 83% of the patients. Grouping patients by entry iPTH level (<600, 600 to 1,200, and >1,200 pg/mL) showed rapid iPTH suppression in the group with the lowest level; greater doses and longer treatment were required in the group with the highest level. During open-label treatment, serum calcium and P levels were 9.2 +/- 0.84 (SD) to 9.7 +/- 1.05 mg/dL and 5.4 +/- 1.10 to 5.9 +/- 1.55 mg/dL, respectively. During double-blinded treatment, serum calcium levels were slightly greater with 1 alpha D-2 than placebo, but P levels did not differ. During double-blinded treatment, 3.26% and 0.46% of serum calcium measurements exceeded 11.2 mg/dL with 1 alpha D-2 and placebo, respectively (P < 0.01); median level was 11.6 mg/dL during hypercalcemia. Intermittent oral 1 1 alpha D-2 therapy effectively suppresses iPTH in hemodialysis patients with secondary hyperparathyroidism, with acceptable mild hypercalcemia and hyperphosphatemia. (C) 2000 by the National Kidney Foundation, Inc.

Language: English

Type (Professor's evaluation): Scientific

No. of pages: 12