Elemental calcium intake associated with calcium acetate/calcium carbonate in the treatment of hyperphosphatemia

Elemental calcium intake associated with calcium acetate/calcium carbonate in the treatment of hyperphosphatemia

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Abstract 

Background: Calcium-based and non-calcium-based phosphate binders have similar efficacy in the treatment of hyperphosphatemia; however, calcium-based binders may be associated with hypercalcemia, vascular calcification, and adynamic bone disease.

Scope: A post hoc analysis was carried out of data from a 16- week, Phase IV study of patients with end-stage renal disease (ESRD) who switched to lanthanum carbonate monotherapy from baseline calcium acetate/calcium carbonate monotherapy. Of the intent-to-treat population (N=2520), 752 patients with recorded dose data for calcium acetate (n=551)/calcium carbonate (n=201) at baseline and lanthanum carbonate at week 16 were studied. Elemental calcium intake, serum phosphate, corrected serum calcium, and serum intact parathyroid hormone levels were analyzed.

Findings: Of the 551 patients with calcium acetate dose data, 271 (49.2%) had an elemental calcium intake of at least 1.5 g/day at baseline, and 142 (25.8%) had an intake of at least 2.0 g/day. Mean (95% confidence interval [CI]) serum phosphate levels were 6.1 (5.89, 6.21) mg/dL at baseline and 6.2 (6.04, 6.38) mg/dL at 16 weeks; mean (95% CI) corrected serum calcium levels were 9.3 (9.16, 9.44) mg/dL and 9.2 (9.06, 9.34) mg/dL, respectively. Of the 201 patients with calcium carbonate dose data, 117 (58.2%) had an elemental calcium intake of at least 1.5 g/day, and 76 (37.8%) had an intake of at least 2.0 g/day. Mean (95% CI) serum phosphate levels were 5.8 (5.52, 6.06) mg/dL at baseline and 5.8 (5.53, 6.05) mg/dL at week 16; mean (95% CI) corrected serum calcium levels were 9.7 (9.15, 10.25) mg/dL and 9.2 (9.06, 9.34) mg/dL, respectively.

Conclusion: Calcium acetate/calcium carbonate phosphate binders, taken to control serum phosphate levels, may result in high levels of elemental calcium intake. This may lead to complications related to calcium balance.

Keywords: calcium acetate, calcium carbonate, calcium phosphates, chronic kidney failure, elemental calcium intake, hyperphosphatemia, lanthanum carbonate.

Abbreviations: Ca x P, calcium phosphate product; CI, confidence interval; ESRD, end-stage renal disease; iPTH, intact parathyroid hormone; ITT, intent-to-treat; KDOQI, Kidney Disease Outcomes Quality Initiative; PTH, parathyroid hormone; SD, standard deviation

Citation: Wilson RJ, Copley JB. Elemental calcium intake associated with calcium acetate/calcium carbonate in the treatment of hyperphosphatemia. Drugs in Context 2017; 6: 212302. DOI: 10.7573/dic.212302

Disclosure and potential conflicts of interest: J Brian Copley is an employee of Shire. Rosamund J Wilson is a consultant to Shire. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests forms for the authors are available for download at: http://www.drugsincontext.com/wp-content/uploads/2017/01/dic.212302-COI.pdf.

Contributions: All named authors meet the ICMJE criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published. All authors contributed equally to the study design, the collection, analysis, and interpretation of data, and the writing of the manuscript.

Acknowledgments: The authors would like to thank Peter Preston for his contributions to the analyses in the manuscript. Writing and editorial support was provided by Fernando Gibson, PhD, and Noëlle L O’Regan, PhD, of PharmaGenesis London, London, UK with funding from Shire Development LLC.

Funding declaration: This analysis was funded by Shire Development LLC. The study sponsor had no direct involvement in the study design, in the collection, analysis, and interpretation of data, in the writing of the manuscript, or in the decision to submit the manuscript for publication.

Clinical trial registration number: ClinicalTrials.gov: NCT00160121

Copyright: Copyright © 2017 Wilson RJ, Copley JB. Distributed under the terms of the Creative Commons License Deed CC BY NC ND 3.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Correct attribution: Copyright © 2017 Wilson RJ, Copley JB. https://doi.org/10.7573/dic.212302. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 3.0.

Article URL: http://www.drugsincontext.com/elemental-calcium-intake-associated-with-calcium-acetate-calcium-carbonate-in-the-treatment-of-hyperphosphatemia

Correspondence: Rosamund J Wilson, Spica Consultants, Marlborough, Wiltshire SN8 3UA, UK. rosamund@spicaconsultants.com

Provenance: Submitted, externally peer reviewed

Submitted: 15 September 2016; Peer review comments to author: 24 October 2016; Publication date: 20 January 2017

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