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

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.