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Vol. 26, No. 1, 2006
Issue release date: April 2006
Am J Nephrol 2006;26:105–114

A Comparison of Dosing Regimens of Paricalcitol Capsule for the Treatment of Secondary Hyperparathyroidism in CKD Stages 3 and 4

Abboud H. · Coyne D. · Smolenski O. · Anger M. · Lunde N. · Qiu P. · Hippensteel R. · Pradhan R.S. · Palaparthy R.V. · Kavanaugh A. · Melnick J.Z. · Williams L.A. · Batlle D.
aUniversity of Texas Health Science Center, San Antonio, Tex., bWashington University, St. Louis, Mo., USA; cProvincial Specialistic Hospital, Krakow, Poland; dUniversity of Colorado, Denver, Colo., eTwin Cities Clinical Research, Arden Hills, Minn., fAbbott Laboratories, Abbott Park, Ill., and gNorthwestern University Feinberg School of Medicine, Chicago, Ill., USA

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Background: Intermittent dosing of calcitriol for secondary hyperparathyroidism (SHPT) has been associated with greater parathyroid hormone (PTH) reduction with fewer calcemic and phosphatemic effects than daily (QD) dosing. Methods: Secondary analyses of three randomized, double-blind, placebo-controlled multicenter studies in stage 3 and 4 chronic kidney disease (CKD) patients with SHPT were performed to compare three times per week (TIW) with QD dosing of paricalcitol. The pharmacokinetics of TIW and QD dosing of paricalcitol capsules were assessed in a separate group of healthy subjects. Results: Pharmacokinetics revealed similar steady state paricalcitol exposure between dosing regimens. In CKD patients, baseline data were similar between the TIW studies (n = 72, paricalcitol; n = 73, placebo) and QD studies (n = 35, paricalcitol; n = 40, placebo). Both dosing regimens resulted in similar efficacy (91%) for the primary end point of two consecutive ≧30% decreases in intact PTH from baseline, but the QD regimen resulted in a greater percent reduction in intact PTH from baseline. The chances for developing increased serum calcium and phosphorus levels or Ca × P product were similar between paricalcitol and placebo groups for both treatment regimens. Furthermore, no difference in the risk for these elevations was detected between the TIW and QD regimens. Conclusions: QD dosing of paricalcitol capsules is as efficacious as TIW dosing in achieving the primary end point (2 consecutive ≧30% reductions in PTH) in stage 3 and 4 CKD patients with SHPT. Moreover, the QD regimen had no significant effect on hypercalcemia, hyperphosphatemia or Ca × P product as compared with placebo or intermittent dosing.

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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 goverment 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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  1. Gonzalez EA, Sachdeva A, Oliver DA, et al: Vitamin D insufficiency and deficiency in chronic kidney disease. A single center observational study. Am J Nephrol 2004;24:503–510.
  2. De Boer IH, Gorodetskaya I, Young B, et al: The severity of secondary hyperparathyroidism in chronic renal insufficiency is GFR-dependent, race-dependent, and associated with cardiovascular disease. J Am Soc Nephrol 2002;13:2762–2769.
  3. Panichi V, Andreini B, De Pietro S, et al: Calcitriol oral therapy for the prevention of secondary hyperparathyroidism in patients with predialytic renal failure. Clin Nephrol 1998;49:245–250.
  4. Goodman WG, Coburn JW: The use of 1,25-dihydroxyvitamin D3 in early renal failure. Annu Rev Med 1992;43:227–237.
  5. Llach F, Velasquez Forero F: Secondary hyperparathyroidism in chronic renal failure: pathogenic and clinical aspects. Am J Kidney Dis 2001;38(5 Suppl 5):S20–S33.

    External Resources

  6. Slatopolsky E, Brown A, Dusso A: Pathogenesis of secondary hyperparathyroidism. Kidney Int Suppl 1999;73:14–19.

    External Resources

  7. Felsenfeld AJ, Rodriguez M: Phosphorus, regulation of plasma calcium, and secondary hyperparathyroidism: a hypothesis to integrate a historical and modern perspective. J Am Soc Nephrol 1999;10:878–890.
  8. Ho LT, Sprague SM: Renal osteodystrophy in chronic renal failure. Semin Nephrol 2002;22:488–493.
  9. Hutchison AJ, Whitehouse RW, Boulton HF, et al: Correlation of bone histology with parathyroid hormone, vitamin D3, and radiology in end-stage renal disease. Kidney Int 1993;44:1071–1077.
  10. Sanchez CP, Goodman WG, Salusky IB: Prevention of renal osteodystrophy in predialysis patients. Am J Med Sci 1999;317:398–404.
  11. Nordal KP, Dahl E, Halse J, et al: Long-term low-dose calcitriol treatment in predialysis chronic renal failure: can it prevent hyperparathyroid bone disease? Nephrol Dial Transplant 1995;10:203–206.
  12. Hamdy NA, Kanis JA, Beneton MN, et al: Effect of alfacalcidol on natural course of renal bone disease in mild to moderate renal failure. BMJ 1995;310:358–363.
  13. Reichel H, Szabo A, Uhl J, et al: Intermittent versus continuous administration of 1,25-dihydroxyvitamin D3 in experimental renal hyperparathyroidism. Kidney Int 1993;44:1259–1265.
  14. Klaus G, Mehls O, Hinderer J, et al: Is intermittent oral calcitriol safe and effective in renal secondary hyperparathyroidism? Lancet 1991;337:800–801.
  15. Coburn JW: Use of oral and parenteral calcitriol in the treatment of renal osteodystrophy. Kidney Int Suppl 1990;29:54–61.
  16. Tsukamoto Y, Nomura M, Takahashi Y, et al: The ‘oral 1,25-dihydroxyvitamin D3 pulse therapy’ in hemodialysis patients with severe secondary hyperparathyroidism. Nephron 1991;57:23–28.
  17. Martin KJ, Gonzalez EA, Gellens M, et al: 19-Nor-1-alpha-25-dihydroxyvitamin D2 (paricalcitol) safely and effectively reduces the levels of intact parathyroid hormone in patients on hemodialysis. J Am Soc Nephrol 1998;9:1427–1432.
  18. Sprague SM, Llach F, Amdahl M, et al: Paricalcitol versus calcitriol in the treatment of secondary hyperparathyroidism. Kidney Int 2003;63:1483–1490.
  19. 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;47:263–276.
  20. Levey AS, Bosch JP, Lewis JB, et al: A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med 1999;130:461–470.
  21. Muramoto H, Haruki K, Yoshimura A, et al: Treatment of refractory hyperparathyroidism in patients on hemodialysis by intermittent oral administration of 1,25(OH)2vitamin D3. Nephron 1991;58:288–294.
  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;139:279–284.
  23. Staniforth ME, Cheng SC, Coyne DW: Once-weekly intravenous paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients. Clin Nephrol 2005;63:454–460.
  24. Coburn JW, Maung HM, Elangovan L, et al: Doxercalciferol safely suppresses PTH levels in patients with secondary hyperparathyroidism associated with chronic kidney disease stages 3 and 4. Am J Kidney Dis 2004;43:877–890.

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