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Recombinant Human Parathyroid Hormone (1–84): A Review in Hypoparathyroidism

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Abstract

Full-length recombinant human parathyroid hormone [rhPTH (1–84); Natpara®] is approved in the USA as an adjunct to calcium and vitamin D therapy for control of hypocalcaemia in patients with hypoparathyroidism. This article reviews the clinical efficacy and tolerability of rhPTH (1–84) in hypoparathyroidism and summarizes its pharmacological properties. In a pivotal phase III trial, subcutaneous rhPTH (1–84) was effective in maintaining albumin-corrected total serum calcium levels while reducing/eliminating the need for oral calcium and active vitamin D. rhPTH (1–84) had a generally acceptable tolerability profile in this trial, with <3 % of patients discontinuing treatment because of adverse events. Commonly occurring adverse reactions included hypocalcaemia, hypercalcaemia and hypercalciuria. As the first PTH replacement therapy for hypoparathyroid patients with hypocalcaemia, rhPTH (1–84) is an effective regimen, has generally acceptable tolerability and represents an important advance for the management of hypoparathyroidism.

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  1. Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand

    Esther S. Kim & Gillian M. Keating

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  1. Esther S. Kim
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Correspondence to Esther S. Kim.

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The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the authors on the basis of scientific and editorial merit. Esther Kim and Gillian Keating are salaried employees of Adis/Springer.

Additional information

The manuscript was reviewed by: P. Divieti-Pajevic, Department of Molecular and Cell Biology, Goldman School of Dental Medicine, Boston University, Boston, MA, USA; T. Sikjaer, Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark; A. L. Wheeler, Department of Medicine, University of California, San Francisco, CA, USA.

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Kim, E.S., Keating, G.M. Recombinant Human Parathyroid Hormone (1–84): A Review in Hypoparathyroidism. Drugs 75, 1293–1303 (2015). https://doi.org/10.1007/s40265-015-0438-2

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