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Table of Contents
Vol. 28, No. 1, 2008
Issue release date: November 2007
Section title: Original Report: Patient-Oriented, Translational Research
Am J Nephrol 2008;28:97–106
(DOI:10.1159/000109398)

Oral Paricalcitol for the Treatment of Secondary Hyperparathyroidism in Patients on Hemodialysis or Peritoneal Dialysis

Ross E.A.a · Tian J.b · Abboud H.c · Hippensteel R.b · Melnick J.Z.b · Pradhan R.S.b · Williams L.A.b · Hamm L.L.d · Sprague S.M.e
aDivision of Nephrology, Hypertension, and Transplantation, University of Florida, Gainesville, Fla., bAbbott Laboratories, Abbott Park, Ill., cDivision of Nephrology, University of Texas Health Science Center, San Antonio, Tex., dSection of Nephrology and Hypertension, Tulane University School of Medicine, New Orleans, La., and eDivision of Nephrology and Hypertension, Evanston Northwestern Healthcare Northwestern University Feinberg School of Medicine, Evanston, Ill., USA

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Article / Publication Details

First-Page Preview
Abstract of Original Report: Patient-Oriented, Translational Research

Received: June 15, 2007
Accepted: August 15, 2007
Published online: October 03, 2007
Issue release date: November 2007

Number of Print Pages: 10
Number of Figures: 4
Number of Tables: 4

ISSN: 0250-8095 (Print)
eISSN: 1421-9670 (Online)

For additional information: http://www.karger.com/AJN

Abstract

Background/Aims: Secondary hyperparathyroidism is a common complication of chronic kidney disease, resulting from inactivation of vitamin D receptor signaling and phosphate retention. Selective activation of vitamin D receptors with intravenous paricalcitol significantly reduced parathyroid hormone (PTH) levels with no significant hypercalcemia or hyperphosphatemia in predialysis and hemodialysis (HD) patients. This study investigates the effects of oral paricalcitol to reduce PTH in patients receiving chronic HD and peritoneal dialysis (PD). Methods: Eighty-eight patients were randomized in double-blind fashion to receive paricalcitol or placebo for 12 weeks. The dose of the study drug was adjusted weekly using the previous week’s intact PTH (iPTH) level as well as calcium and Ca × P product levels. The primary end points were efficacy (two consecutive iPTH decreases of ≧30%) and safety (two consecutive calcium measurements >11.0 mg/dl). Markers of biochemical bone activity were followed. Results: Demographic characteristics were similar between treatment groups. The mean paricalcitol doses (three times a week) over the entire treatment period for subjects with baseline iPTH ≤500 pg/ml and iPTH >500 pg/ml were 3.9 and 7.6 µg, respectively. A statistically significant decrease in iPTH was seen after week 1, with a mean 30% reduction occurring by week 3. A significantly greater proportion of both HD and PD paricalcitol subjects [83% (33/40) and 100% (18/18), respectively] achieved two consecutive ≧30% decreases in iPTH. The treatment groups were not statistically different in regard to the hypercalcemia safety end point. Phosphate binder use and mean serum phosphorus levels were not different between the treatment groups. The markers of bone activity improved in the treated subjects and worsened in those on placebo. Conclusion: Paricalcitol provides a rapid and sustained reduction of PTH in both HD and PD patients with minimal effect on serum calcium and phosphorus and no significant difference in adverse events as compared with placebo.

© 2007 S. Karger AG, Basel


Article / Publication Details

First-Page Preview
Abstract of Original Report: Patient-Oriented, Translational Research

Received: June 15, 2007
Accepted: August 15, 2007
Published online: October 03, 2007
Issue release date: November 2007

Number of Print Pages: 10
Number of Figures: 4
Number of Tables: 4

ISSN: 0250-8095 (Print)
eISSN: 1421-9670 (Online)

For additional information: http://www.karger.com/AJN


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Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
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 government 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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