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A comparison of dosing regimens of paricalcitol capsule for the treatment of secondary hyperparathyroidism in CKD stages 3 and 4.
- Source :
-
American journal of nephrology [Am J Nephrol] 2006; Vol. 26 (1), pp. 105-14. Date of Electronic Publication: 2006 Mar 14. - Publication Year :
- 2006
-
Abstract
- Background: Intermittent dosing of calcitriol for secondary hyperparathyroidism (SHPT) has been associated with greater parathyroid hormone (PTH) reduction with fewer calcemic and phosphatemic effects than daily (QD) dosing.<br />Methods: Secondary analyses of three randomized, double-blind, placebo-controlled multicenter studies in stage 3 and 4 chronic kidney disease (CKD) patients with SHPT were performed to compare three times per week (TIW) with QD dosing of paricalcitol. The pharmacokinetics of TIW and QD dosing of paricalcitol capsules were assessed in a separate group of healthy subjects.<br />Results: Pharmacokinetics revealed similar steady state paricalcitol exposure between dosing regimens. In CKD patients, baseline data were similar between the TIW studies (n = 72, paricalcitol; n = 73, placebo) and QD studies (n = 35, paricalcitol; n = 40, placebo). Both dosing regimens resulted in similar efficacy (91%) for the primary end point of two consecutive > or = 30% decreases in intact PTH from baseline, but the QD regimen resulted in a greater percent reduction in intact PTH from baseline. The chances for developing increased serum calcium and phosphorus levels or Ca x P product were similar between paricalcitol and placebo groups for both treatment regimens. Furthermore, no difference in the risk for these elevations was detected between the TIW and QD regimens.<br />Conclusions: QD dosing of paricalcitol capsules is as efficacious as TIW dosing in achieving the primary end point (2 consecutive > or = 30% reductions in PTH) in stage 3 and 4 CKD patients with SHPT. Moreover, the QD regimen had no significant effect on hypercalcemia, hyperphosphatemia or Ca x P product as compared with placebo or intermittent dosing.<br /> (Copyright 2006 S. Karger AG, Basel)
- Subjects :
- Adult
Aged
Aged, 80 and over
Calcium blood
Capsules
Chronic Disease
Double-Blind Method
Drug Administration Schedule
Ergocalciferols pharmacokinetics
Female
Humans
Male
Middle Aged
Parathyroid Hormone blood
Phosphorus blood
Prospective Studies
Vitamins administration & dosage
Vitamins pharmacokinetics
Ergocalciferols administration & dosage
Hyperparathyroidism, Secondary drug therapy
Kidney Diseases complications
Subjects
Details
- Language :
- English
- ISSN :
- 0250-8095
- Volume :
- 26
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- American journal of nephrology
- Publication Type :
- Academic Journal
- Accession number :
- 16543714
- Full Text :
- https://doi.org/10.1159/000092033