The effect of sevelamer carbonate and lanthanum carbonate on the pharmacokinetics of oral calcitriol

Nephrology Dialysis Transplantation

Volumn 26, Issue 5, 2011, Pages 1615-1621

  Pierce, David ^a   Hossack, Stuart ^b   Poole, Lynne ^a   Robinson, Antoine ^c   Van Heusen, Heather ^c   Martin, Patrick ^c   Smyth, Michael ^a  

^a Shire Pharmaceuticals   (United Kingdom)

^b 206 Carnegie Center   (United Kingdom)

^c SHIRE   (United States)

Author keywords

bioavailability; calcitriol; chronic kidney disease; lanthanum carbonate; sevelamer carbonate

Indexed keywords

CALCITRIOL; LANTHANUM CARBONATE; SEVELAMER CARBONATE;

ADULT; ANXIETY; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DRUG ANTAGONISM; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG INDUCED HEADACHE; FEMALE; HEMATOMA; HUMAN; HUMAN EXPERIMENT; HYPESTHESIA; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; URINARY TRACT INFECTION; XEROSTOMIA;

ADMINISTRATION, ORAL; ADULT; CALCITRIOL; CHELATING AGENTS; CROSS-OVER STUDIES; FEMALE; HUMANS; KIDNEY FAILURE, CHRONIC; LANTHANUM; MALE; MIDDLE AGED; POLYAMINES; TISSUE DISTRIBUTION; YOUNG ADULT;

EID: 79955638836     PISSN: 09310509     EISSN: 14602385     Source Type: Journal    
DOI: 10.1093/ndt/gfq598     Document Type: Article

References (34)

1. LaClair RE, Hellman RN, Karp SL et al. Prevalence of calcidiol de-ficiency in CKD: a cross-sectional study across latitudes in the Uni-ted States. Am JKidney Dis 2005; 45: 1026-1033 (Pubitemid 40806515)
2. Pesenson A, Maski M, Kaufman J. Prevalence of 25-OH vitamin D deficiency in patients with chronic kidney disease and effects of cor-rection following KDOQI guidelines. Poster Presentation at the American Society of Nephrology Renal Week, San Diego, CA, USA, 14-19 November 2006
3. Craver L, Marco MP, Martinez I et al. Mineral metabolism parameters throughout chronic kidney disease stages 1-5-achievement of K/DOQI target ranges. Nephrol Dial Transplant 2007; 22: 1171-1176 (Pubitemid 46523434)
4. Al-Badr W, Martin KJ. Vitamin D and kidney disease. Clin JAm Soc Nephrol 2008; 3: 1555-1560
5. Wang TJ, Pencina MJ, Booth SL et al. Vitamin D deficiency and risk of cardiovascular disease. Circulation 2008; 117: 503-511
6. Kulie T, Groff A, Redmer J et al. Vitamin D: an evidence-based re-view. JAm Board Fam Med 2009; 22: 698-706
7. Eknoyan G, Levin A, Levin NW. Bone metabolism and disease in chronic kidney disease. Am J Kidney Dis 2003; 42: 1-201
8. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work Group. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease-min-eral and bone disorder (CKD-MBD). Kidney Int 2009; 76: S1-S130
9. Ritz E, Kuster S, Schmidt-Gayk H et al. Low-dose calcitriol prevents the rise in 1,84-iPTH without affecting serum calcium and phosphate in patients with moderate renal failure (prospective placebo-controlled multicentre trial). Nephrol Dial Transplant 1995; 10: 2228-2234 (Pubitemid 26033434)
10. Wolf M, Shah A, Gutierrez O et al. Vitamin D levels and early mor-tality among incident hemodialysis patients. Kidney Int 2007; 72: 1004-1013 (Pubitemid 47530570)
11. Bleyer AJ, Burke SK, Dillon M et al. A comparison of the calcium-free phosphate binder sevelamer hydrochloride with calcium acetate in the treatment of hyperphosphatemia in hemodialysis patients. Am J Kidney Dis 1999; 33: 694-701 (Pubitemid 29159935)
12. Hutchison AJ, Maes B, Vanwalleghem J et al. Efficacy, tolerability, and safety of lanthanum carbonate in hyperphosphatemia: a 6-month, randomized, comparative trial versus calcium carbonate. Nephron Clin Pract 2005; 100: c8-c19 (Pubitemid 40674602)
13. Suki WN, Zabaneh R, Cangiano JL et al. Effects of sevelamer and calcium-based phosphate binders on mortality in hemodialysis pa-tients. Kidney Int 2007; 72: 1130-1137 (Pubitemid 47609037)
14. Wilson R, Zhang P, Smyth M et al. Assessment ofsurvival in a 2-year comparative study of lanthanum carbonate versus standard therapy Curr Med Res Opin 2009; 25: 3021-3028
15. Block GA, Spiegel DM, Ehrlich J et al. Effects of sevelamer and cal-cium on coronary artery calcification in patients new to hemodialysis. Kidney Int 2005; 68: 1815-1824 (Pubitemid 43169927)
16. Braunlin W, Zhorov E, Guo A et al. Bile acid binding to sevelamer HCl. Kidney Int 2002; 62: 611-619 (Pubitemid 34779775)
17. Autissier V, Damment SJ, Henderson RA. Relative in vitro efficacy of the phosphate binders lanthanum carbonate and sevelamer hydro-chloride. J Pharm Sci 2007; 96: 2818-2827 (Pubitemid 47597830)
18. Fraser DR. Vitamin D. Lancet 1995; 345: 104-107
19. US Prescribing Information Renagel (Sevelamer hydrochloride), Silver Spring, MD, USA, Center for Drug Evaluation and Research. http://www.accessdata. fda.gov/drugsatfda-docs/label/2007/021179s020lbl.pdf(20 September 2010, date last accessed)
20. Hutchison AJ, Barnett ME, Krause R et al. Long-term efficacy and safety profile of lanthanum carbonate: results for up to 6 years of treatment. Nephron Clin Pract 2008; 110: c15-c23
21. Finn WF. Lanthanum carbonate versus standard therapy for the treat-ment of hyperphosphatemia: safety and efficacy in chronic mainten-ance hemodialysis patients. Clin Nephrol 2006; 65: 191-202 (Pubitemid 43337998)
22. Ketteler M, Rix M, Fan S et al. Efficacy and tolerability of sevelamer carbonate in hyperphosphatemic patients who have chronic kidney disease and are not on dialysis. Clin JAm Soc Nephrol 2008; 3: 1125-1130
23. Evenepoel P, Selgas R, Caputo F et al. Efficacy and safety of seve-lamer hydrochloride and calcium acetate in patients on peritoneal dialysis. Nephrol Dial Transplant 2009; 24: 278-285
24. Fan S, Ross C, Mitra S et al. A randomized, crossover design study of sevelamer carbonate powder and sevelamer hydrochloride tablets in chronic kidney disease patients on haemodialysis. Nephrol Dial Transplant 2009; 24: 3794-3799
25. Slatopolsky EA, Burke SK, Dillon MA. RenaGel, a nonabsorbed cal-cium-and aluminum-free phosphate binder, lowers serum phosphorus and parathyroid hormone. The RenaGel Study Group. Kidney Int 1999; 55: 299-307 (Pubitemid 29004263)
26. Chertow GM, Burke SK, Raggi P. Sevelamer attenuates the progres-sion of coronary and aortic calcification in hemodialysis patients. Kidney Int 2002; 62: 245-252 (Pubitemid 34754068)
27. Application Number 021068 and 18044/S025. Clinical Pharmacol-ogy and Biopharmaceutics Review(S). Silver Spring, MD, USA: Cen-ter for Drug Evaluation and Research. http://www.accessdata.fda.gov/drugsatfda-docs/nda/98/021068a- clinphrm.pdf(11 February 2010, date last accessed)
28. Genzyme Therapeutics. Renvela Prescribing Information. 2008. http://www.renvela.com/docs/renvela-PI.pdf(11 February 2010, date last accessed)
29. Finn W, Sprague S, Abboud H et al. 25-Hydroxyvitamin D levels in patients with CKD Stage 3 and 4 are not affected by lanthanum car-bonate: results from a randomized multicentre trial. Nephrol Dial Transplant 2008; 1: ii59
30. Plone MA, Petersen JS, Rosenbaum DP et al. Sevelamer, a phos-phate-binding polymer, is a non-absorbed compound. Clin Pharma-cokinet 2002; 41: 517-523 (Pubitemid 34804163)
31. Wrong O, Harland C Sevelamer and other anion-exchange resins in the prevention and treatment of hyperphosphataemia in chronic renal failure. Nephron Physiol 2007; 107: 17-33
32. Takagi K, Masuda K, Yamazaki M et al. Metal ion and vitamin adsorp-tion profiles of phosphate binder ion-exchange resins. Clin Nephrol 2010; 73: 30-35
33. Lemay J, Demers C, Hendy GN et al. Expression of the 1,25-dihy- droxyvitamin D3-24-hydroxylase gene in rat intestine: response to calcium, vitamin D3 and calcitriol administration in vivo. J Bone Miner Res 1995; 10: 1148-1157
34. Jin SE, Park JS, Kim CK. Pharmacokinetics of oral calcitriol in healthy human based on the analysis with an enzyme immunoassay Pharmacol Res 2009; 60: 57-60