Sevelamer as a phosphate binder in adult hemodialysis patients: An evidence-based review of its therapeutic value

Core Evidence

Volumn 1, Issue 1, 2005, Pages 43-63

  Nadin, Carole ^a  

^a Core Medical Publishing ^*  (United Kingdom)

Author keywords

Calcium salts; Chronic kidney disease; Evidence; Hemodialysis; Phosphate binder; Sevelamer

Indexed keywords

ALUMINUM SALT; CALCIUM; CALCIUM PHOSPHATE; CALCIUM SALT; LANTHANUM CARBONATE; LIPID; MAGNESIUM SILICATE; PARATHYROID HORMONE; PHOSPHATE; PHOSPHATE BINDING AGENT; SEVELAMER; URIC ACID; VITAMIN D;

ABDOMINAL PAIN; ARTERY CALCIFICATION; ARTERY DISEASE; BONE DENSITY; CHRONIC KIDNEY DISEASE; CLINICAL TRIAL; CONSTIPATION; COST EFFECTIVENESS ANALYSIS; DIARRHEA; DOSE RESPONSE; DRUG BINDING; DRUG EFFECT; DRUG SYNTHESIS; DRUG USE; DYSPEPSIA; GASTROINTESTINAL DISEASE; HEARTBURN; HEMODIALYSIS; HOSPITALIZATION; HUMAN; HYPERCALCEMIA; HYPERPARATHYROIDISM; HYPERPHOSPHATEMIA; LIPID BLOOD LEVEL; META ANALYSIS; METABOLIC ACIDOSIS; MORBIDITY; MORTALITY; NAUSEA; PATHOGENESIS; PATIENT COMPLIANCE; PHOSPHATE BLOOD LEVEL; QUALITY OF LIFE; REVIEW; SOFT TISSUE CALCIFICATION; SYSTEMATIC REVIEW; URIC ACID BLOOD LEVEL; VITAMIN SUPPLEMENTATION;

EID: 33646486443     PISSN: 15551741     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (89)

1. Achinger SG, Ayus JC. The role of daily dialysis in the control of hyperphosphatemia. Kidney Int. 2005;67(Suppl. 95):S28-S32.
2. Almirall J, Lopez T, Vallve M, Ruiz A, Llibre J, Betriu A. Safety and efficacy of sevelamer in the treatment of uncontrolled hyperphosphataemia of haemodialysis patients. Nephron Clin Pract. 2004;97:c17-c22.
3. Anon. Renagel Product Monograph. Naarden, The Netherlands: Genzyme Europe BV; 2004.
4. Apostolou T, Pappas C, Christodoulidou C, et al. Sevelamer hydrochloride in resistant hyperphosphatemia in hemodialysis patients. Nephrol Dial Transplant. 2002;17(Abstracts Suppl.):68 (Abstract M66).
5. Blacher J, Guérin AP, Pannier B, Marchais SJ, London GM. Arterial calcifications, arterial stiffness, and cardiovascular risk in end-stage renal disease. Hypertension. 2001;38:938-942.
6. 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.
7. Block GA, Hulbert-Shearon TE, Levin NW, Port FK. 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.
8. Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004;15:2208-2218.
9. Bommer J, Locatelli F, Satayathum S, et al. Association of predialysis serum bicarbonate levels with risk of mortality and hospitalization in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2004;44:661-671.
10. Braun J, Asmus HG, Holzer H, et al. Long-term comparison of a calcium-free phosphate binder and calcium carbonate-phosphorus metabolism and cardiovascular calcification. Clin Nephrol. 2004;62:104-115.
11. Brezina B, Qunibi WY, Nolan CR. Acid loading during treatment with sevelamer hydrochloride: mechanisms and clinical implications. Kidney Int. 2004;66(Suppl. 90):S39-S45.
12. Brophy DF, Wallace JF, Kennedy DT, Gehr TWB, Holdford DA. Cost-effectiveness of sevelamer versus calcium carbonate plus atorvastatin to reduce LDL in patients with chronic renal insufficiency with dyslipidemia and hyperphosphatemia. Pharmacotherapy. 2000;20:950-957.
13. Burke SK, Slatopolsky EA, Goldberg DI. RenaGel®, a novel calcium- and aluminium-free phosphate binder, inhibits phosphate absorption in normal volunteers. Nephrol Dial Transplant. 1997;12:1640-1644.
14. Burke SK, Dillon MA, Hemken DE, Rezabek MS, Balwit JM. Meta-analysis of the effect of sevelamer on phosphorus, calcium, PTH, and serum lipids in dialysis patients. Adv Renal Replacement Therapy. 2003;10:133-145.
15. Caro JJ, Huybrechts KF, Wilson DA, London GM. Sevelamer use in hyperphosphatemia: health and economic consequences. J Am Soc Nephrol. 2003;14:444A (Abstract SA-P0669).
16. Castro R, Herman A, Ferreira C, Travassos F, Nunes-Azevedo J, Oliveira M. Renagel® efficacy in severe secondary hyperparathyroidism. Nefrologia. 2002;22:448-455.
17. Chertow GM, Burke SK, Lazarus JM, et al. Poly[allylamine hydrochloride] (RenaGel): a noncalcemic phosphate binder for the treatment of hyperphosphatemia in chronic renal failure. Am J Kidney Dis. 1997;29:66-71.
18. Chertow GM, Dillon M, Burke SK, et al. A randomized trial of sevelamer hydrochloride (RenaGel) with and without supplemental calcium. Clin Nephrol. 1999a;51:18-26.
19. Chertow GM, Burke SK, Dillon MA, Slatopolsky E. Long-term effects of sevelamer hydrochloride on the calcium × phosphate product and lipid profile of haemodialysis patients. Nephrol Dial Transplant. 1999b;14:2907-2914.
20. Chertow GM, Dillon MA, Amin N, Burke SK. Sevelamer with and without calcium and vitamin D: observations from a long-term open-label clinical trial. J Renal Nutr. 2000;10:125-132.
21. Chertow GM, Burke SK, Raggi P. Sevelamer attenuates the progression of coronary and aortic calcification in hemodialysis patients. Kidney Int. 2002;62:245-252.
22. Chertow GM, Raggi P, McCarthy JT, et al. The effects of sevelamer and calcium acetate on proxies of atherosclerotic and arteriosclerotic vascular disease in hemodialysis patients. Am J Nephrol. 2003;23:307-314.
23. Chertow GM, Raggi P, Chasan-Taber S, Bommer J, Holzer H, Burke SK. Determinants of progressive vascular calcification in haemodialysis patients. Nephrol Dial Transplant. 2004;19:1489-1496.
24. Chudek J, Piecha G, Kokot F, Wiecek A. Influence of sevelamer hydrochloride on serum concentration of whole (1-84) and N-terminally truncated (7-84) parathyroid hormone fragments in hemodialysis uremic patients. J Nephrol. 2003;16:710-715.
25. Ciampi MA, Reilly RF. Long-term sevelamer use is associated with a higher serum phosphate, higher Ca × P product and lower serum bicarbonate than calcium-containing binders. J Am Soc Nephrol. 2002;13:586A-587A (Abstract SU-P0578).
26. Collins AJ, St Peter WL, Dalleska FW, Ebben JP, Ma JZ. Hospitalization risks between Renagel phosphate binder treated and non-Renagel treated patients. Clin Nephrol. 2000;54:334-341.
27. Don BR, Chin AI. A strategy for the treatment of calcific uremic arteriolopathy (calciphylaxis) employing a combination of therapies. Clin Nephrol. 2003;59:463-470.
28. Drüeke TB. Renal osteodystrophy: management of hyperphosphataemia. Nephrol Dial Transplant. 2000;15(Suppl. 5):32-33.
29. Drüeke TB. The place of calcium and calcimimetics in the treatment of secondary hyperparathyroidism. Nephrol Dial Transplant. 2001;16(Suppl. 6):15-17.
30. Drüeke TB, Rostand SG. Progression of vascular calcification in uraemic patients: can it be stopped? Nephrol Dial Transplant. 2002;17:1365-1368.
31. Emmett M. A comparison of clinically useful phosphorus binders for patients with chronic kidney failure. Kidney Int. 2004;66(Suppl. 90):S25-S32.
32. Fleischmann EH, Bower JD, Salahudeen AK. Are conventional cardiovascular risk factors predictive of two-year mortality in hemodialysis patients? Clin Nephrol. 2001;56:221-230.
33. Floege J, Ketteler M. Vascular calcification in patients with end-stage renal disease. Nephrol Dial Transplant. 2004;19(Suppl. 5):V59-V66.
34. Foley RN, Murray AM, Li S, et al. Chronic kidney disease and the risk for cardiovascular disease, renal replacement, and death in the United States Medicare population, 1998 to 1999. J Am Soc Nephrol. 2005;16:489-495.
35. Gallieni M, Cozzoiino M, Carpani P, Zoni U, Brancaccio D. Sevelamer reduces calcium load and maintains a low calcium-phosphorus ion product in dialysis patients. J Nephrol. 2001;14:176-183.
36. Garg JP, Chasan-Taber S, Blair A, et al. Effects of sevelamer and calcium-based phosphate binders on uric acid concentrations in patients undergoing hemodialysis. Arthritis Rheum. 2005;52:290-295.
37. Goldberg DI, Dillon MA, Slatopolsky EA, et al. Effect of RenaGel®, a nonabsorbed, calcium- and aluminium-free phosphate binder, on serum phosphorus, calcium and intact parathyroid hormone in end-stage renal disease patients. Nephrol Dial Transplant. 1998;13:2303-2310.
38. Guérin AP, London GM, Marchais SJ, Metivier F. Arterial stiffening and vascular calcifications in end-stage renal disease. Nephrol Dial Transplant. 2000;15:1014-1021.
39. Hergesell O, Ritz E. Phosphate binders in uraemia: pharmacodynamics, pharmaceoeconomics, pharmacoethics. Nephrol Dial Transplant. 2002;17:14-17.
40. Hervás JG, Prados D, Cerezo S. Treatment of hyperphosphatemia with sevelamer hydrochloride in hemodialysis patients: a comparison with calcium acetate. Kidney Int. 2003;63(Suppl. 85):S69-S72.
41. Huu TC, Heiz C, Hachicha M, Bellou M, Kessler M. Prospective survey of sevelamer (Genzyme) in hemodialysis patients with hyperphosphoremia. J Am Soc Nephrol. 2002;13:586A (Abstract SU-P0575).
42. Huybrechts KF, Caro JJ, London GM. Modeling the implications of changes in vascular calcification in patients on hemodialysis. Kidney Int. 2005;67:1532-1538.
43. Jorna FH, Tobé TJM, Huisman RM, de Jong PE, Plukker JTM, Stegeman CA. Early identification of risk factors for refractory secondary hyperparathyraidism in patients with long-term renal replacement therapy. Nephrol Dial Transplant. 2004;19:1168-1173.
44. Kalantar-Zadeh K, Mehrotra R, Fouque D, Kopple JD. Metabolic acidosis and malnutrition-inflammation complex syndrome in chronic renal failure. Semin Dial. 2004;17:455-465.
45. Kazama JJ. Osteoprotegerin and bone mineral metabolism in renal failure. Curr Opin Nephrol Hypertens. 2004;13:411-415.
46. Level C, Lasseur C, Delmas Y, et al. Determinants of arterial compliance in patients treated by hemodialysis. Clin Nephrol. 2001;56:435-444.
47. Llach F. The evolving pattern of calciphylaxis: therapeutic considerations. Nephrol Dial Transplant. 2001;16:448-451.
48. Loghman-Adham M. Safety of new phosphate binders for chronic renal failure. Drug Safety. 2003;26:1093-1115.
49. London GM, Guérin AP, Marchais SJ, Métivier F, Pannier B, Adda H. Arterial media calcification in end-stage renal disease: impact on all-cause and cardiovascular mortality. Nephrol Dial Transplant. 2003;18:1731-1740.
50. London GM, Marchais SJ, Guerin AP, Pannier B. Arterial stiffness: pathophysiology and clinical impact. Clin Exp Hypertens. 2004;26:689-699.
51. Lorenzo V, Martin-Malo A, Perez-Garcia R, et al. Prevalence and clinical correlates of mineral abnormalities among Spanish hemodialysis patients. Presented at the American Society of Nephrology Annual Meeting 2004, available at: www.abstracts2view.com/asn/view.php?nu=ASN4L1_1187a.
52. Manley HJ, Garvin CG, Drayer DK, et al. Medication prescribing patterns in ambulatory hemodialysis patients: comparisons of USRDS to a large not-for-profit dialysis provider. Nephrol Dial Transplant. 2004;19:1842-1848.
53. Manns B, Stevens L, Miskulin D, Owen WF, Winklemayer WC, Tonelli M. A systematic review of sevelamer in ESRD and an analysis of its potential economic impact in Canada and the United States. Kidney Int. 2004;66:1239-1247.
54. Marino A, Giotta N, Biamino E, Bongiorno P. Lipid effect of sevelamer in haemodialyzed patients. Nephrol Dial Transplant. 2002;17(Abstracts Suppl.):70 (Abstract M71).
55. McCullough PA. Opportunities for improvement in the cardiovascular care of patients with end-stage renal disease. Adv Chronic Kidney Dis. 2004;11:294-303.
56. McCullough PA, Sandberg KR, Dumler F, Yanez JE. Determinants of coronary vascular calcification in patients with chronic kidney disease and end-stage renal disease: a systematic review. J Nephrol. 2004;17:205-215.
57. McIntyre CW, Patel V, Taylor GS, Fluck RJ. A prospective study of combination therapy for hyperphospnataemia with calcium-containing phosphate binders and sevelamer in hypercalcaemic haemodialysis patients. Nephrol Dial Transplant. 2002;17:1643-1648.
58. Mitsopoulos E, Griveas I, Kyriklidou P, et al. Effects of sevelamer hydrochloride (Renagel) on biochemical profil [sic] in haemodialysis (HD) patient. Nephrol Dial Transplant. 2002a;17(Abstracts Suppl.):69 (Abstract M70).
59. Mitsopoulos E, Griveas I, Kyriklidou P, et al. Effects of sevelamer hydrochloride (Renagel) in haemodialysis patients with secondary hyperparathyroidism (sHPT). Nephrol Dial Transplant. 2002b;17(Abstracts Suppl.):69 (Abstract M69).
60. NKF (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-S201. Available at: www.kidney.org.
61. NSF (National Service Framework). National Service Framework for Renal Services. Part one: dialysis and transplantation. London: Department of Health; January 2004. Available at: www.doh.gov.uk/nsf/renal.
62. Ogata H, Koiwa F, Shishido K, Kinugasa E. Combination therapy with sevelamer hydrochloride and calcium carbonate in Japanese patients with long-term hemodialysis: alternative approach for optimal mineral management. Ther Apher Dial. 2005;9:11-15.
63. Plone MA, Petersen JS, Rosenbaum DP, Burke SK. Sevelamer, a phosphate-binding polymer, is a nonabsorbed compound. Clin Pharmacokinet. 2002;41:517-523.
64. Qunibi WY, Nolan CR. Economic impact of sevelamer in patients with ESRD. Kidney Int. 2005;67:1636-1637.
65. Qunibi WY, Hootkins RE, McDowell LL, et al. Treatment of hyperphosphatemia in hemodialysis patients: the Calcium Acetate Renagel Evaluation (CARE study). Kidney Int. 2004;65:1914-1926.
66. Raggi P, Burke SK, Chasan-Taber S, Chertow GM, Holzer H, Bommer J. Sevelamer preserves and calcium reduces trabecular bone mineral density. J Am Soc Nephrol. 2003;14:502A (Abstract SA-PO924).
67. Raggi P, Bommer J, Chertow GM. Valvular calcification in hemodialysis patients randomized to calcium-based phosphorus binders or sevelamer. J Heart Valve Dis. 2004;13:134-141.
68. Raggi P, James G, Burke SK, et al. Decrease in thoracic vertebral bone attenuation with calcium-based phosphate binders in hemodialysis. J Bone Miner Res. 2005;20:764-772.
69. Russell R, Brookshire MA, Zekonis M, Moe SM. Distal calcific uremic arteriolopathy in a hemodialysis patient responds to lowering of Ca × P product and aggressive wound care. Clin Nephrol. 2002;58:238-243.
70. Sadek T, Mazouz H, Bahloul H, et al. Sevelamer hydrochloride with or without alphacalcidol or higher dialysate calcium vs calcium carbonate in dialysis patients: an open-label, randomized study. Nephrol Dial Transplant. 2003;18:582-589.
71. Salusky IB, Goodman WG. Managing phosphate retention: is a change necessary? Nephrol Dial Transplant. 2000;15:1738-1742.
72. Sandberg G, Theodorou V, Valis D. Effects of sevelamer hydrochloride (SH) as a phosphate binder, and its favorable chanches [sic] on the lipid profile of hemodialyzed patients. Nephrol Dial Transplant. 2002;17(Abstracts Suppl.):68 (Abstract M65).
73. Shaheen FA, Akeel NM, Badawi LS, Souqiyyeh MZ. Efficacy and safety of sevelamer. Comparison with calcium carbonate in the treatment of hyperphosphatemia in hemodialysis patients. Saudi Med J. 2004;25:785-791.
74. Shishido K, Ogata H, Yamamoto M, Koiwa F, Kinugasa E. Clinical effect of combination treatment with sevelamer hydrochloride and calcium carbonate in hemodialysis patients. Presented at the American Society of Nephrology Annual Meeting 2004, available at: www.abstracts2view.com/asn/view.php?nu=ASN4L1_2157a
75. Slatopolsky EA, Burke SK, Dillon MA. RenaGel®, a nonabsorbed calcium- and aluminium-free phosphate binder, lowers serum phosphorus and parathyroid hormone. Kidney Int. 1999;55:299-307.
76. Slatopolsky E, Brown A, Dusso A. Role of phosphorus in the pathogenesis of secondary hyperparathyroidism. Am J Kidney Dis. 2001;37(Suppl. 2):S54-S57.
77. Smrzova J, Surel S, Rehorova J, Rychlik I. Treatment of calcium-phosphate disturbances according to new K/DOQI guidelines recommendations - a single-center study. Presented at the American Society of Nephrology Annual Meeting 2004, available at: www.abstracts2view.com/asn/view.php?nu=ASN4L1_2418a.
78. Sonikian M, Pani I, Mantakas A, Hadjilouka A, Vlassopoulos D. One year experience with sevelamer hydrochloride (SH) in hemodialysis (HD) patients. Nephrol Dial Transplant. 2002;17(Abstracts Suppl.):70 (Abstract M73).
79. Sonikian MA, Pani IT, Iliopoulos AN, Koutala KG, Marioli SI, Vlassopoulos DA. Metabolic acidosis aggravation and hyperkaliemia in hemodialysis patients treated by sevelamer hydrochloride. Pen Fail. 2005;27:143-147.
80. Sturtevant JM, Hawley CM, Reiger K, et al. Efficacy and side-effect profile of sevelamer hydrochloride used in combination with conventional phosphate binders. Nephrology. 2004;9:406-413.
81. Tajiri S, Kitamura K, Adachi M, et al. Comparison of phosphate binding capacity of sevelamer hydrochloride with colestimide in vitro and in vivo. Presented at the American Society of Nephrology Annual Meeting 2004, available at: www.abstracts2view.com/asn/view.php?nu=ASN4L1_1959a
82. Takenaka T, Suzuki H. New strategy to attenuate pulse wave velocity in haemodialysis patients. Nephrol Dial Transplant. 2005;20:811-816.
83. Tomasello S, Dhupar S, Sherman RA. Phosphate binders, K/DOQI guidelines, and compliance: the unfortunate reality. Dial Transplant. 2004;33:236-240.
84. Vlahakos DV, Retsa K, Kalogeropoulou S, et al. Long-term acidosis in hemodialysis (HD) patients (pts) treated with sevelamer hydrochloride: a two-year follow-up study. Presented at the American Society of Nephrology Annual Meeting 2004, available at: www.abstracts2view.com/asn/view.php?nu=ASN4L1_1899a
85. Walters BA, Delahunty MI, Rojas C, Pennell P, Bosch JP. Control of serum phosphate level by sevelamer hydrochloride may occur at the expense of lowering serum bicarbonate in hemodialysis patients. J Am Soc Nephrol. 2002a;13:586A (Abstract SU-P0577).
86. Walters BA, Delahunty MI, Nabut JL, Pennell P, Bosch JR Reduction in cardiac mortality in hemodialysis patients on sevelamer hydrochloride compared with phosphate binders containing calcium. J Am Soc Nephrol. 2002b;13:596A (Abstract SU-P0625).
87. Wilkes BM, Reiner D, Kern M, Burke S. Simultaneous lowering of serum phosphate and LDL cholesterol by sevelamer hydrochloride (RenaGel) in dialysis patients. Clin Nephrol. 1998;50:381-386.
88. Yamada K, Fujimoto S, Nishiura R, et al. Effects of sevelamer on dyslipidemia and chronic inflammation in maintenance hemodialysis patients. Presented at the American Society of Nephrology Annual Meeting 2004, available at: www.abstracts2view.com/asn/view.php?nu=ASN4L1_2197a
89. Young EW, Akiba T, Albert JM, et al. Magnitude and impact of abnormal mineral metabolism in hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2004:44(Suppl. 2):S34-S38.