A comparison of dosing regimens of paricalcitol capsule for the treatment of secondary hyperparathyroidism in CKD stages 3 and 4

Hanna Abboud, Daniel Coyne, Olgierd Smolenski, Michael Anger, Norman Lunde, Ping Qiu, Rich Hippensteel, Rajendra S. Pradhan, Rameshraja V. Palaparthy, Anne Kavanaugh, Joel Z. Melnick, Laura A. Williams, Daniel Batlle*

*Corresponding author for this work

Research output: Contribution to journalArticle

16 Scopus citations

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. 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. 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 ≥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. Conclusions: QD dosing of paricalcitol capsules is as efficacious as TIW dosing in achieving the primary end point (2 consecutive ≥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.

Original languageEnglish (US)
Pages (from-to)105-114
Number of pages10
JournalAmerican Journal of Nephrology
Volume26
Issue number1
DOIs
StatePublished - Apr 2006

Keywords

  • Hypercalcemia
  • Hyperphosphatemia
  • Intermittent dosing, paricalcitol
  • Once-daily dosing, paricalcitol
  • Pulse dosing, paricalcitol
  • Vitamin D
  • Vitamin D receptor activator

ASJC Scopus subject areas

  • Nephrology

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    Abboud, H., Coyne, D., Smolenski, O., Anger, M., Lunde, N., Qiu, P., Hippensteel, R., Pradhan, R. S., Palaparthy, R. V., Kavanaugh, A., Melnick, J. Z., Williams, L. A., & Batlle, D. (2006). A comparison of dosing regimens of paricalcitol capsule for the treatment of secondary hyperparathyroidism in CKD stages 3 and 4. American Journal of Nephrology, 26(1), 105-114. https://doi.org/10.1159/000092033