Effects of paricalcitol on calcium and phosphate metabolism and markers of bone health in patients with diabetic nephropathy: Results of the VITAL study

Nephrology Dialysis Transplantation

Volumn 28, Issue 9, 2013, Pages 2260-2268

  Coyne, Daniel W ^a   Andress, Dennis L ^b   Amdahl, Michael J ^b   Ritz, Eberhard ^c   De Zeeuw, Dick ^d  

^a WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b ABBVIE INC   (United States)

^c UNIVERSITY OF HEIDELBERG   (Germany)

^d UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

Author keywords

Bone specific alkaline phosphatase; Calcitriol; Hypercalcemia; Hyperphosphatemia; Paricalcitol; Vitamin D receptor activation

Indexed keywords

ALKALINE PHOSPHATASE BONE ISOENZYME; BIOLOGICAL MARKER; PARATHYROID HORMONE; PARICALCITOL; PLACEBO;

ADULT; AGED; ARTICLE; CALCIUM BLOOD LEVEL; CALCIUM METABOLISM; CALCIUM URINE LEVEL; CHRONIC KIDNEY DISEASE; CONTROLLED STUDY; DIABETIC NEPHROPATHY; DISEASE SEVERITY; DOSE RESPONSE; DRUG DOSE COMPARISON; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ENZYME BLOOD LEVEL; FEMALE; HUMAN; HYPERCALCEMIA; MAJOR CLINICAL STUDY; MALE; PHOSPHATE BLOOD LEVEL; PHOSPHATE METABOLISM; PHOSPHATE URINE LEVEL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SECONDARY HYPERPARATHYROIDISM;

BONE-SPECIFIC ALKALINE PHOSPHATASE; CALCITRIOL; HYPERCALCEMIA; HYPERPHOSPHATEMIA; PARICALCITOL; VITAMIN D RECEPTOR ACTIVATION;

AGED; ALKALINE PHOSPHATASE; BIOLOGICAL MARKERS; BONE AND BONES; BONE DENSITY CONSERVATION AGENTS; CALCIUM; DIABETIC NEPHROPATHIES; DOUBLE-BLIND METHOD; ERGOCALCIFEROLS; FEMALE; HUMANS; MALE; MIDDLE AGED; PARATHYROID HORMONE; PHOSPHATES;

EID: 84884514624     PISSN: 09310509     EISSN: 14602385     Source Type: Journal    
DOI: 10.1093/ndt/gft227     Document Type: Article

References (42)

1. Gal-Moscovici A, Sprague SM. Use of vitamin D in chronic kidney disease patients. Kidney Int 2010; 78: 146-151
2. Herzog CA. Dismal long-term survival of dialysis patients after acute myocardial infarction: can we alter the outcome? Nephrol Dial Transplant 2002; 17:7-10
3. Kestenbaum B, Sampson JN, Rudser KD et al. Serum phosphate levels and mortality risk among people with chronic kidney disease. J Am Soc Nephrol 2005; 16: 520-528
4. Kovesdy CP, Kuchmak O, Lu JL et al. Outcomes associated with serum calcium level in men with non-dialysis-dependent chronic kidney disease. Clin J Am Soc Nephrol 2010; 5: 468-476
5. Block GA, Hulbert-Shearon TE, Levin NW et al. Association of serum phosphorus and calcium × phosphate product with mortality risk in chronic hemodialysis patients: a national study. Am J Kidney Dis 1998; 31: 607-617
6. Palmer SC, Hayen A, Macaskill P et al. Serum levels of phosphorus, parathyroid hormone, and calcium and risks of death and cardiovascular disease in individuals with chronic kidney disease: a systematic review and meta-analysis. JAMA 2011; 305: 1119-1127
7. Slinin Y, Foley RN, Collins AJ. Calcium, phosphorus, parathyroid hormone, and cardiovascular disease in hemodialysis patients: the USRDS waves 1, 3, and 4 study. J Am Soc Nephrol 2005; 16: 1788-1793
8. Tonelli M, Sacks F, Pfeffer M et al. Cholesterol and Recurrent Events Trial Investigators. Relation between serum phosphate level and cardiovascular event rate in people with coronary disease. Circulation 2005; 112: 2627-2633
9. de Boer IH, Rue TC, Kestenbaum B. Serum phosphorus concentrations in the third National Health and Nutrition Examination Survey (NHANES III). Am J Kidney Dis 2009; 53: 399-407
10. Dhingra R, Sullivan LM, Fox CS et al. Relations of serum phosphorus and calcium levels to the incidence of cardiovascular disease in the community. Arch Intern Med 2007; 167: 879-885
11. Fahrleitner-Pammer A, Herberth J, Browning SR et al. Bone markers predict cardiovascular events in chronic kidney disease. J Bone Miner Res 2008; 23: 1850-1858
12. Kovesdy CP, Ureche V, Lu JL et al. Outcome predictability of serum alkaline phosphatase in men with pre-dialysis CKD. Nephrol Dial Transplant 2010; 25: 3003-3011
13. Ravani P, Malberti F, Tripepi G et al. Vitamin D levels and patient outcome in chronic kidney disease. Kidney Int 2009; 75: 88-95
14. Wolf M, Shah A, Gutierrez O et al. Vitamin D levels and early mortality among incident hemodialysis patients. Kidney Int 2007; 72: 1004-1013
15. 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 randomised controlled trial. Lancet 2010; 376: 1543-1551
16. Shoben AB, Rudser KD, de Boer IH et al. Association of oral calcitriol with improved survival in nondialyzed CKD. J Am Soc Nephrol 2008; 19: 1613-1619
17. Teng M, Wolf M, Ofsthun MN et al. Activated injectable vitamin D and hemodialysis survival: a historical cohort study. J Am Soc Nephrol 2005; 16: 1115-1125
18. Hayashi M, Tsuchiya Y, Itaya Y et al. Comparison of the effects of calcitriol and maxacalcitol on secondary hyperparathyroidism in patients on chronic haemodialysis: a randomized prospective multicentre trial. Nephrol Dial Transplant 2004; 19: 2067-2073
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. Zemplar [package insert]. North Chicago, IL: Abbott Laboratories, 2011
21. Mizobuchi M, Morrissey J, Finch JL et al. Combination therapy with an angiotensin-converting enzyme inhibitor and a vitamin D analog suppresses the progression of renal insufficiency in uremic rats. J Am Soc Nephrol 2007; 18: 1796-1806
22. Tan X, Li Y, Liu Y. Paricalcitol attenuates renal interstitial fibrosis in obstructive nephropathy. J Am Soc Nephrol 2006; 17: 3382-3393
23. 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 Nephrol 2008; 28: 97-106
24. Kalantar-Zadeh K, Kuwae N, Regidor DL et al. Survival predictability of time-varying indicators of bone disease in maintenance hemodialysis patients. Kidney Int 2006; 70: 771-780
25. Shinaberger CS, Kopple 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: 1769-1776
26. Teng M, Wolf M, Lowrie E et al. Survival of patients undergoing hemodialysis with paricalcitol or calcitriol therapy. N Engl J Med 2003; 349: 446-456
27. Lambers Heerspink HJ, Agarwal R, Coyne DW et al. The selective vitamin D receptor activator for albuminuria lowering (VITAL) study: study design and baseline characteristics. Am J Nephrol 2009; 30: 280-286
28. Omar H, Chamberlin A, Walker V et al. Immulite 2000 parathyroid hormone assay: stability of parathyroid hormone in EDTA blood kept at room temperature for 48 h. Ann Clin Biochem 2001; 38: 561-563
29. Alwin DF, Hauser RM. The decomposition of effects in path analysis. Am Sociol Rev 1975; 40: 37-47
30. Wright S. The method of path coefficients. In: The Annals of Mathematical Statistics. Beachwood, OH, Institute of Mathematical Statistics, 1934, pp. 161-215
31. Lu Y. An application of path analysis in the design of clinical trials. In: Abstract presented at: Joint Statistical Meetings 2003, 3-7 August 2003, San Francisco, CA
32. Palmer SC, McGregor DO, Macaskill P et al. Meta-analysis: vitamin D compounds in chronic kidney disease. Ann Intern Med 2007; 147: 840-853
33. Baker LR, Abrams L, Roe CJ et al. 1,25(OH)2D3 administration in moderate renal failure: a prospective double-blind trial. Kidney Int 1989; 35: 661-669
34. Coyne DW, Grieff M, Ahya SN et al. Differential effects of acute administration of 19-Nor-1,25-dihydroxy-vitamin D2 and 1,25-dihydroxy-vitamin D3 on serum calcium and phosphorus in hemodialysis patients. Am J Kidney Dis 2002; 40: 1283-1288
35. Nordal KP, Dahl E. Low dose calcitriol versus placebo in patients with predialysis chronic renal failure. J Clin Endocrinol Metab 1988; 67: 929-936
36. Sprague SM, Llach F, Amdahl M et al. Paricalcitol versus calcitriol in the treatment of secondary hyperparathyroidism. Kidney Int 2003; 63: 1483-1490
37. Hansen D, Rasmussen K, Danielsen H et al. No difference between alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients: a randomized crossover trial. Kidney Int 2011; 80: 841-850
38. Brancaccio D, Tetta C, Gallieni M et al. Inflammation, CRP, calcium overload and a high calcium-phosphate product: a 'liaison dangereuse'. Nephrol Dial Transplant 2002; 17: 201-203
39. Hruska KA, Mathew S, Lund R et al. Hyperphosphatemia of chronic kidney disease. Kidney Int 2008; 74: 148-157
40. Greenbaum LA, Benador N, Goldstein SL et al. Intravenous paricalcitol for treatment of secondary hyperparathyroidism in children on hemodialysis. Am J Kidney Dis 2007; 49: 814-823
41. Lund RJ, Andress DL, Amdahl M et al. Differential effects of paricalcitol and calcitriol on intestinal calcium absorption in hemodialysis patients. Am J Nephrol 2010; 31: 165-170
42. Frazão JM, Adragão T. Treatment of hyperphosphatemia with sevelamer hydrochloride in dialysis patients: effects on vascular calcification, bone and a close look into the survival data. Kidney Int 2008; 74: S38-S43