Safety and tolerability of paricalcitol in patients with chronic kidney disease

Expert Opinion on Drug Safety

Volumn 12, Issue 5, 2013, Pages 717-728

  Dyer, Christopher A ^a  

^a UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

Author keywords

Chronic kidney disease; Hyperparathyroidism; Paricalcitol; Proteinuria; Vitamin D

Indexed keywords

ALFACALCIDOL; CALCITRIOL; CALCIUM; CINACALCET; DOXERCALCIFEROL; ERGOCALCIFEROL; PARATHYROID HORMONE; PARICALCITOL; PHOSPHORUS; PLACEBO; VITAMIN D DERIVATIVE; VITAMIN D RECEPTOR;

CALCIUM BLOOD LEVEL; CHRONIC KIDNEY DISEASE; COMPARATIVE STUDY; COUGHING; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG ERUPTION; DRUG EXCRETION; DRUG HALF LIFE; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG USE; HEMODIALYSIS; HEMODIALYSIS PATIENT; HUMAN; HYPERCALCEMIA; HYPERPHOSPHATEMIA; KIDNEY FAILURE; MULTICENTER STUDY (TOPIC); OUTCOME ASSESSMENT; PARATHYROID HORMONE BLOOD LEVEL; PERITONEAL DIALYSIS; PHASE 3 CLINICAL TRIAL (TOPIC); PHOSPHATE BLOOD LEVEL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RENIN ANGIOTENSIN ALDOSTERONE SYSTEM; REVIEW; SAFETY; SECONDARY HYPERPARATHYROIDISM; SINGLE DRUG DOSE; TREATMENT OUTCOME;

ERGOCALCIFEROLS; HUMANS; HYPERPARATHYROIDISM, SECONDARY; RECEPTORS, CALCITRIOL; RENAL INSUFFICIENCY, CHRONIC;

EID: 84882996914     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2013.791675     Document Type: Review

References (57)

1. Levin A, Bakris GL, Molitch M, et al. Prevalence of abnormal serum vitamin D, PTH, calcium, and phosphorus in patients with chronic kidney disease: results of the study to evaluate early kidney disease. Kidney Int 2007;71:31-8
2. Martinez I, Saracho R, Montenegro J, Llach F. The importance of dietary calcium and phosphorus in the secondary hyperparathyroidism of patients with early renal failure. Am J Kidney Dis 1997;29:496-502
3. Ketteler M, Martin KJ, Cozzoline M, et al. Paricalcitol versus cinacalcet plus low dose vitamin D for the treatment of secondary hyperparathyroidism in patients receiving hemodialysis: study design and baseline characteristics of the IMPACT SHPT study. Nephrol Dial Transplant 2012;27:1942-9
4. Joy MS, Karagiannis PC, Peyerl FW. Outcomes of secondary hyperparathyroidism in chronic kidney disease and the direct costs of treatment. J Manag Care Pharm 2007;13:397-411
5. Raggi P, Kleerekoper M. Contribution of bone and mineral abnormalities to cardiovascular disease in patients with chronic kidney disease. Clin J Am Soc Nephrol 2008;3:836-43
6. Mak RH, Betinelli A, Turner C, et al. The influence of hyperparathyroidism on glucose metabolism in uremia. J Clin Endocrinol Metab 1985;60:229-33
7. Cogan MG, Covey CM, Arieff AI, et al. Central nervous system manifestations of hyperparathyoroidism. Am J Med 1978;65:963-70
8. Gaciong Z, Alexiewicz JM, Linker-Israeli M, et al. Inhibition of immunoglobulin production by parathyroid hormone. Implications in chronic renal failure. Kidney Int 1991;40:96-106
9. Grutzmacher P, Radtke HW, Fassbinder W, et al. Effect of secondary hyperparathyroidism on the anaemia of end-stage renal failure: in vivo and in vitro studies. Proc Eur Dial Transplant Assoc 1983;20:739-45
10. Go AS, Chertow G, Fan D, et al. Chronic kidney disease and the risks of death, cardiovascular events and hospitalization. New Engl J Med 2004;351:1296-305
11. deZeeum D, Agarwal R, Amdahl M, et al. Selective vitamin D receptor activation with paricalcitol for reduction of albuminuria in patients with type 2 diabetes (VITAL study): a randomised controlled trial. Lancet 2010;376:1543-51
12. Goldberg MM. Paricalcitol, a new agent for the management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis. Clin Ther 1999;21:432-41
13. Amizuka N, Ozawa H. Intracellular localization and translocation of 1alpha, 25-dihydroxyvitamin D3 receptor in osteoblasts. Arch Histol Cytol 1992;55:77-88
14. Berger U, Wilson P, McClelland RA, et al. Immunocytochemical detection of 1,25-dihydroxyvitamin D receptors in normal human tissues. J Clin Endocrinol Metab 1998;67:607-13
15. Rodriguez M, Felsenfled AJ, Llach F. Calcemic response to parathyroid hormone in renal failure: role of calcitrol and the effect of parathyroidectomy. Kidney Int 1991;40:1063-8
16. De Francisco ALM Secondary Hyperparathyroidism: review of the disease and its treatment. Clin Ther 2004;26:1976-93
17. Slatopolsky E, Cavanaugh J, Cato A. Pharmacokinetics of paracalcin (19-nor- 1 alpha, 25-dihydroxyvitamin D2) in healthy subjects [abstract]. International Congress of Nephrology; 25-29 May 1997
18. Lee RD, Grabowski B, Johnson MK, et al. Disposition and excretion of [3H] 19-nor-1 alpha, 25 dihydroxyvitamin D2 in humans [abstract]. J Bone Miner Res 1997;12(Suppl):S453
19. Cato A, Cady WW, Sotanek C. Effect of hemodialysis on the pharmacokinetics of 19-nor-1 alpha, 25 dihydroxyvitamin D2. Am J Kidney Dis 1998;32(Suppl 2):S55-60
20. Highlights of prescribing information Zemplar (paricalcitol) capsules, Abbott Laboratories 2010
21. Ross EA, Tian J, Abboud H, et al. Oral paricalcitol for the treatment of secondary hyperparathyroidism in patients on hemodialysis or peritoneal dialysis. Am J Nephro 2008;28:97-106 . The first trial
22. Llach F, Keshav G, Goldblat MV, et al. Suppression of Parathyroid hormone Secretion in hemodialysis Patients by a Novel Vitamin D Analogue: 19-Nor- 1,25-Dihydroxyvitamin D2. Am J Kidney Dis 1998;32:S48-54
23. Martin KJ, Gonzalez EA, Gellens M, et al. 19-Nor-1-a-25-dihydroxyvitamin D2 (Paricalcitol) safely and effectively reduces the levels of intact parathyroid hormone in patients on hemodialysis. J Am Soc Nephrol 1998;9:1427-32
24. Martin KJ, Gonzalez EA, Gellens ME, et al. Therapy of secondary hyperparathyroidism with 19-Nor-1a, 25-dihydroxyvitamin D2. Am J Kidney Dis 1998;32:S61-6
25. Lindberg J, Martin KJ, Gonzalez EA, et al. A long-term, multicenter study of the efficacy and safety of paricalcitol in end-stage renal disease. Clin Nephrol 2001;56:315-23
26. National Kidney Foundation. K/DOQI Clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis 2003;42(Suppl 3):S1-201
27. Coyne D, Acharya M, Qiu P, et al. Paricalcitol capsule for the treatment of secondary hyperparthyroidism in stages 3 and 4 CKD. Am J Kidney Dis 2006;47:263-76
28. Agarwal R, Achura M, Tian J, et al. Antiproteinuric effect of oral paricalcitol in chronic kidney disease. Kidney Int 2005;68:2823-8
29. Alborzi P, Patel NA, Peterson C, et al. Paricalcitol reduces albuminuria and inflammation in chronic kidney disease: a randomized double blind pilot trial. Hypertension 2008;52:249-55
30. Fishbane S, CHittineni H, Packman M, et al. Oral paricalcitol in the treatment of patients with CKD and proteinuria: a randomized trial. Am J Kidney Dis 2009;54:647-52
31. Szeto CC, Chow KM, Kway BC, et al. Oral calcitriol for the treatment of persistent proteinuria in immunoglobulin A nephropathy: an uncontrolled trial. Am J Kidney Dis 2008;51:724-31
32. De Zeeuw D, Agarwal R, Amdahl M, et al. Selective vitamin D receptor activation with paricalcitol for reduction of albuminuria in patients with type 2 diabetes (VITAL study): a randomized controlled trial Lancet. 2010;376:1543-51
33. Holick MF. Vitamin D deficiency. N Engl J Med 2007;375:266-81
34. Levin A, Djurdjev O, Thompson C, et al. Canadian randomized trial of hemoglobin maintenance to prevent or delay left ventricular mass growth in patients with CKD. Am J Kidney Dis 2005;46:799-811
35. Autier P, Gandini S. Vitamin d supplementation and total mortality: a meta-analysis of randomized controlled trials. Arch Int Med 2007;167:1730-7
36. Wang TJ, Pencina MJ, Booth SL, et al. Vitamin D deficiency and risk of cardiovascular disease. Circulation 2008;117:503-11
37. Thadhani R, Appelbaum E, Prtichett Y, et al. Vitamin D therapy and cardiac structure and function in patients with chronic kidney disease, The PRIMO Randomized Controlled Trial. JAMA 2012;307:674-84
38. Nakane M, Fey TA, Dixon DB, et al. Differential effects of vitamin D analogs on bone formation and resorption. J Steroid Biochem Mol Biol 2006;98:72-7
39. Teng M, Wolf M, Lowrie E, et al. Survival of patients undergoing hemodialysis with paricalcitol or calcitriol therapy. N Engl J Med 2003;349:446-56
40. Tentori F, Hunt WC, Stidley CA, et al. Mortality risk among hemodialysis patients receiving different vitamin D analogs. Kidney Int 2006;70:1858-65
41. Brancaccio D, Cozzolino M, Cannella G, et al. Secondary hyperparathyroidism in chronic dialysis patients: results of the italian FARO survey on treatment and mortality. Blood Purif 2011;32:124-32
42. Shinaberger CS, Dopple JD, Kovesdy CP, et al. Ratio of paricalcitol dosage to serum parathyroid hormone level and survival in maintenance hemodialysis patients. Clin J Am Soc Nephrol 2008;3:1769-76
43. Miller JE, Molnar MZ, Kovesdy CP, et al. Administered paricalcitol dose and survival in hemodialysis patients: a marginal structural model analysis. Pharmacoepidemiol Drug Saf 2012;21:1232-9
44. Lund R, Tian J, Melnick J, et al. Differential effects of paricalcitol and calcitriol on intestinal calcium absorption in hemodialysis patients [abstract no SP=607]. XLIII European renal association-European Dialysis and Transplant Association (ERA-EDTA) Congress; 15-18 July 2006; Glasgow
45. Sprague S, Llach F, Amdahl M, et al. Paricalcitol versus calcitriol in the treatment of secondary hyperparathyroidism. Kidney Int 2003;63:1483-90
46. Mittman N, Desiraju B, Meyer KB, et al. Treatment of secondary hyperparathyroidism in ESRD: a 2-year, single center crossover study. Kidney Int 2010;78(Suppl 117):S33-6
47. Desiraju B, Mittman N, Meyer K, et al. Treatment of secondary hyperparathyroidism (SHPT) with paricalcitol versus calcitriol: a two year, single center crossover comparison [abstract no. SA-PO1009]. American Society of Nephrology (ASN) 39th Renal Week Meeting; 14-19 November 2006; San Diego (CA)
48. Llach F, Yudd M. Paricalcitol in dialysis patients with calcitriol-resistant secondary hyperparathyroidism. Am J Kidney Dis 2001;38(5 Suppl 5):S45-50
49. Joist HE, Ahya SN, Giles K, et al. Differential effects of very high doses of doxercalciferol and paricalcitol on serum phosphorus in hemodialysis patients. Clin Nephrol 2006;65:335-41
50. Moe SM, Drueke T, Cunningham J, et al. Definition, evaluation, and classification of renal osteodystrophy: a position statement from Kidney Disease: improving Global Outcomes (KDIGO). Kidney Int 2006;69:1945-53
51. Vervloet MG, Grooteman MP, Ter Wee PM. Improved parathyroid hormone levels after conversion from intravenous alfacalcidiol to intravenous paricalcitol [abstract no. PUB 343]. American Society of Nephrology (ASN) 39th Renal Week Meeting; 14-19 November 2006; San Diego (CA)
52. Hansen DM, Rasmussen K, Danielsen H, et al. No difference between alfacalcidiol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients: a randomized crossover trial. Kidney Int 2011;80:841-50
53. Fishbane S, Shapiro WB, Corry DB, et al. Cinacalcet HCl and concurrent low-dose vitamin d improves treatment of secondary hyperparathyroidism in dialysis patients compared with vitamin d alone: the achieve study results. Clin J Am Soc Nephrol 2008;3:1718-25
54. Ketteler M, Martin KJ, Wolf M, et al. Paricalcitol vsersus cinacalcet plus low-dose vitamin D therapy for the treatment of secondary hyperparathyroidism in patients receiving hemodialysis: results of the IMPACT SHPT study. Nephrol Dial Transplant 2012;27:3270-8
55. The EVOLVE Trial Investigators. Effect of cinacalcet on cardiovascular disease in patients undergoing dialysis. New Engl J Med 2012;367:2482-94
56. Kovesdy CP, Lu JL, Malakauskas SM, et al. paricalcitol versus ergocalciferol for secondary hyperparathyroidism in CKD stages 3 and 4: a Randomized controlled trial. Am J Kidney Dis 2012;59:58-66
57. Moe SM, Saifullah A, LaClair RE, et al. A randomized trial of cholecalciferol versus doxercalciferol for lowering parathyroid hormone in chronic kidney disease. Clin J Am Soc Nephrol 2010;5:299-306