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Table of Contents
Vol. 26, No. 1, 2006
Issue release date: April 2006
Am J Nephrol 2006;26:105–114
(DOI:10.1159/000092033)

A Comparison of Dosing Regimens of Paricalcitol Capsule for the Treatment of Secondary Hyperparathyroidism in CKD Stages 3 and 4

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.
aUniversity of Texas Health Science Center, San Antonio, Tex., bWashington University, St. Louis, Mo., USA; cProvincial Specialistic Hospital, Krakow, Poland; dUniversity of Colorado, Denver, Colo., eTwin Cities Clinical Research, Arden Hills, Minn., fAbbott Laboratories, Abbott Park, Ill., and gNorthwestern University Feinberg School of Medicine, Chicago, Ill., USA

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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 × 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 × P product as compared with placebo or intermittent dosing.



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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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