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Oral Paricalcitol

  • Apis Drug Profile
  • Published:
Treatments in Endocrinology

Abstract

  • ▴ An oral formulation of paricalcitol has been developed for the prevention and treatment of secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease.

  • ▴ Paricalcitol is a synthetic vitamin D analog that binds to the vitamin D receptor inducing suppression of parathyroid hormone (PTH) secretion.

  • ▴ Oral paricalcitol was significantly more effective than placebo in treating secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease. In a pooled analysis of three well designed, 24-week trials, two consecutive reductions from baseline in intact PTH levels of ≥30% were achieved by significantly more paricalcitol than placebo recipients (91% vs 13%).

  • ▴ In addition, mean levels of the biochemical bone markers serum bone-specific alkaline phosphatase, serum osteocalcin, and urinary pyridinoline were reduced from baseline to a significantly greater extent with paricalcitol than with placebo, indicating a reduction in bone turnover.

  • ▴ Oral paricalcitol was well tolerated; there was no significant difference between paricalcitol and placebo recipients in the incidence of hypercalcemia, hyperphosphatemia, or elevated calcium-phosphorus product.

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Notes

  1. The use of trade names is for product identification purposes only and does not imply endorsement.

References

  1. National Kidney Foundation [online]. Available from URL: http://www.kidney.org/kidneydisease [Accessed 2006 May 15]

  2. National Kidney Foundation. Kidney disease outcomes quality initiative [online]. Available from URL: http://www.kidney.org/professionals/kdoqi [Accessed 2006 May 17]

  3. Slatopolsky E, Brown A, Dusso A. Pathogenesis of secondary hyperparathyroidism. Kidney Int Suppl 1999; 73: S14–9

    Article  PubMed  CAS  Google Scholar 

  4. Brown AJ, Coyne DW. Vitamin D analogs. New therapeutic agents for secondary hyperparathyroidism. Treat Endocrinol 2002; 1(5): 313–27

    Article  PubMed  CAS  Google Scholar 

  5. Coyne D, Acharya M, Qiu P, et al. Paricalcitol capsule for the treatment of secondary hyperparathyroidism in stages 3 and 4 CKD. Am J Kidney Dis 2006 Feb; 47(2): 263–76

    Article  PubMed  CAS  Google Scholar 

  6. Martin KJ, González EA. Strategies to minimize bone disease in renal failure. Am J Kidney Dis 2001 Dec; 38(6): 1430–6

    Article  PubMed  CAS  Google Scholar 

  7. Goodman WG, Goldin J, Kuizon BD, et al. Coronary-artery calcification in young adults with end-stage renal disease who are undergoing dialysis. N Engl J Med 2000; 342(20): 1478–83

    Article  PubMed  CAS  Google Scholar 

  8. Slatopolsky E, Weerts C, Thielan J, et al. Marked suppression of secondary hyperparathyroidism by intravenous administration of 1,25-dihydroxy-cholecalciferol in uremic patients. J Clin Invest 1984; 74: 2136–43

    Article  PubMed  CAS  Google Scholar 

  9. Quarles LD, Yohay DA, Carroll BA, et al. Prospective trial of pulse oral versus intravenous calcitriol treatment of hyperparathyroidism in ESRD. Kidney Int 1994; 45: 1710–21

    Article  PubMed  CAS  Google Scholar 

  10. Abbott Laboratories Ltd. Zemplar 5 microgram/ml solution for injection: summary of product characteristics [online]. Available from URL: http://www.emc.medicines.org.uk [Accessed 2006 May 23]

  11. Robinson DM, Scott LJ. Paricalcitol: a review of its use in the management of secondary hyperparathyroidism. Drugs 2005; 65(4): 559–76

    Article  PubMed  CAS  Google Scholar 

  12. Agarwal R, Acharya M, Tian J, et al. Antiproteinuric effect of oral paricalcitol in chronic kidney disease. Kidney Int 2005 Dec; 68(6): 2823–8

    Article  PubMed  CAS  Google Scholar 

  13. Abboud H, Coyne D, Smolenski O, et al. A comparison of dosing regimens of paricalcitol capsule for the treatment of secondary hyperparathyroidism in CKD stages 3 and 4. Am J Nephrol 2006 Mar 14; 26(1): 105–14

    Article  PubMed  CAS  Google Scholar 

  14. Abbott Laboratories. Zemplar® (paricalcitol) capsules: US prescribing information [online]. Available from URL: http://www.rxabbott.com/pdf/Zemplarcappi.pdf [Accessed 2006 May 2]

  15. Wu-Wong JR, Tian J, Goltzman D. Vitamin D analogs as therapeutic agents: a clinical study update. Curr Opin Investig Drugs 2004 Mar; 5(3): 320–6

    PubMed  CAS  Google Scholar 

  16. Schroeder NJ, Burrin JM, Noonan K, et al. Effects of ‘non-calcaemic’ vitamin D analogues on 24-hydroxylase expression in MG-63 osteoblast-like cells. Nephron Physiol 2003; 94: 62–73

    Article  Google Scholar 

  17. Issa LI, Leong GM, Sutherland RL, et al. Vitamin D analogue-specific recruitment of vitamin D receptor coactivators. J Bone Miner Res 2002; 17(5): 879–90

    Article  PubMed  CAS  Google Scholar 

  18. Slatopolsky E, Finch J, Ritter C, et al. A new analog of calcitriol, 19-nor-1,25-(OH)2D2, suppresses parathyroid hormone secretion in uremic rats in the absence of hypercalcemia. Am J Kidney Dis 1995 Nov; 26(5): 852–60

    Article  PubMed  CAS  Google Scholar 

  19. Slatopolsky E, Cozzolino M, Lu Y, et al. Efficacy of 19-nor-1,25-(OH)2D2 in the prevention and treatment of hyperparathyroid bone disease in experimental uremia. Kidney Int 2003 Jun; 63(6): 2020–7

    Article  PubMed  CAS  Google Scholar 

  20. Takahashi F, Finch JL, Denda M, et al. A new analog of 1,25-(OH)2D3, 19-nor-1,25-(OH)2D2, suppresses serum PTH and parathyroid gland growth in uremic rats without elevation of intestinal vitamin D receptor content. Am J Kidney Dis 1997 Jul; 30(1): 105–12

    Article  PubMed  CAS  Google Scholar 

  21. Cozzolino M, Lu Y, Finch J, et al. p21WAF1 and TGF-α mediate parathyroid growth arrest by vitamin D and high calcium. Kidney Int 2001 Dec; 60(6): 2109–17

    Article  PubMed  CAS  Google Scholar 

  22. Brown AJ, Finch J, Slatopolsky E. Differential effects of 19-nor-1,25-dihydroxyvitamin D2 and 1,25-dihydroxyvitamin D3 on intestinal calcium and phosphate transport. J Lab Clin Med 2002 May; 139(5): 279–84

    Article  PubMed  CAS  Google Scholar 

  23. Brown AJ, Finch J, Takahashi F, et al. Calcemic activity of 19-nor-1,25(OH)2D2 decreases with duration of treatment. J Am Soc Nephrol 2000 Nov; 11(11): 2088–94

    PubMed  CAS  Google Scholar 

  24. Holliday LS, Gluck SL, Slatopolsky E, et al. 1,25-dihydroxy-19-nor-vitamin D2, a vitamin D analog with reduced bone resorbing activity in vitro. J Am Soc Nephrol 2000 Oct; 11(10): 1857–64

    PubMed  CAS  Google Scholar 

  25. Finch JL, Brown AJ, Slatopolsky E. Differential effects of 1,25-dihydroxy-vitamin D3 and 19-nor-1,25-dihydroxy-vitamin D2 on calcium and phosphorus resorption in bone. J Am Soc Nephrol 1999 May; 10(5): 980–5

    PubMed  CAS  Google Scholar 

  26. Balint E, Marshall F, Sprague SM. Effect of the vitamin D analogues paricalcitol and calcitriol on bone mineral in vitro. Am J Kidney Dis 2000 Oct; 36(4): 789–96

    Article  PubMed  CAS  Google Scholar 

  27. Data on file, Abbott Laboratories Ltd, 2006

  28. Bailie GR, Massry SG. Clinical practice guidelines for bone metabolism and disease in chronic kidney disease: an overview. Pharmacotherapy 2005; 25(12): 1687–707

    Article  PubMed  CAS  Google Scholar 

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Authors and Affiliations

  1. Adis International Inc., 770 Township Line Road, Suite 300, Yardley, Pennsylvania, 19067, USA

    Emma D. Deeks & Katherine A. Lyseng-Williamson

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  1. Emma D. Deeks
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  2. Katherine A. Lyseng-Williamson
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Correspondence to Emma D. Deeks.

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Deeks, E.D., Lyseng-Williamson, K.A. Oral Paricalcitol. Treat Endocrinol 5, 319–325 (2006). https://doi.org/10.2165/00024677-200605050-00005

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