Long-term efficacy and safety of iron-based phosphate binders, ferric citrate hydrate and sucroferric oxyhydroxide, in hemodialysis patients.
End-stage renal disease
Ferritin
Iron
Phosphate
Phosphate binders
Journal
International urology and nephrology
ISSN: 1573-2584
Titre abrégé: Int Urol Nephrol
Pays: Netherlands
ID NLM: 0262521
Informations de publication
Date de publication:
Apr 2022
Apr 2022
Historique:
received:
03
03
2021
accepted:
06
07
2021
pubmed:
16
7
2021
medline:
18
3
2022
entrez:
15
7
2021
Statut:
ppublish
Résumé
Iron-based phosphate binders, including ferric citrate hydrate (FCH) and sucroferric oxyhydroxide (SFOH), have been used for the treatment of hyperphosphatemia in end-stage renal disease patients on dialysis. However, the long-term efficacy and safety of these agents have not yet been clearly elucidated. Laboratory data of 56 hemodialysis patients who had been prescribed either FCH (n = 33) or SFOH (n = 23) were retrospectively examined. We showed that both FCH and SFOH significantly and consistently decreased serum phosphate concentrations in the patients undergoing maintenance hemodialysis during the 36-month observation period. Serum levels of calcium, intact parathyroid hormone, as well as hemoglobin levels were unaltered. No overshoot of parameters of iron metabolism, such as transferrin saturation and serum ferritin levels, was observed, and serum ferritin level remained under 300 ng/mL in most patients. A trend towards decrease in the doses of erythropoiesis-stimulating agents used and frequency of intravenous iron use was observed in both treatment groups. No severe adverse drug reactions were observed in either the patients receiving FCH or SFOH. The results of the present study suggest that the iron-based phosphate binders, FCH and SFOH, decrease serum phosphate concentrations consistently and are safe to use over the long-term in maintenance hemodialysis patients.
Identifiants
pubmed: 34264473
doi: 10.1007/s11255-021-02952-1
pii: 10.1007/s11255-021-02952-1
doi:
Substances chimiques
Drug Combinations
0
Ferric Compounds
0
Phosphates
0
sucroferric oxyhydroxide
0
Sucrose
57-50-1
ferric citrate
63G354M39Z
Iron
E1UOL152H7
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
861-872Informations de copyright
© 2021. The Author(s), under exclusive licence to Springer Nature B.V.
Références
Hruska KA, Mathew S, Lund R, Qiu P, Pratt R (2008) Hyperphosphatemia of chronic kidney disease. Kidney Int 74:148–157
doi: 10.1038/ki.2008.130
Vervloet MG, van Ballegooijen AJ (2018) Prevention and treatment of hyperphosphatemia in chronic kidney disease. Kidney Int 93:1060–1072
doi: 10.1016/j.kint.2017.11.036
Fukagawa M, Yokoyama K, Koiwa F, Taniguchi M, Shoji T, Kazama JJ, Komaba H, Ando R, Kakuta T, Fujii H, Nakayama M, Shibagaki Y, Fukumoto S, Fujii N, Hattori M, Ashida A, Iseki K, Shigematsu T, Tsukamoto Y, Tsubakihara Y, Tomo T, Hirakata H, Akizawa T, CKD-MBD Guideline Working Group; Japanese Society for Dialysis Therapy (2013) Clinical practice guideline for the management of chronic kidney disease-mineral and bone disorder. Ther Apher Dial 17:247–288
doi: 10.1111/1744-9987.12058
Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group (2017) KDIGO 2017 clinical practice guideline update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease-mineral and bone disorder (CKD-MBD). Kidney Int Suppl 7:1–59
doi: 10.1016/j.kisu.2017.04.001
Isakova T, Gutiérrez OM, Chang Y, Shah A, Tamez H, Smith K, Thadhani R, Wolf M (2009) Phosphorus binders and survival on hemodialysis. J Am Soc Nephrol 20:388–396
doi: 10.1681/ASN.2008060609
Lopes AA, Tong L, Thumma J, Li Y, Fuller DS, Morgenstern H, Bommer J, Kerr PG, Tentori F, Akiba T, Gillespie BW, Robinson BM, Port FK, Pisoni RL (2012) Phosphate binder use and mortality among hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS): evaluation of possible confounding by nutritional status. Am J Kidney Dis 60:90–101
doi: 10.1053/j.ajkd.2011.12.025
Lewis JB, Sika M, Koury MJ, Chuang P, Schulman G, Smith MT, Whittier FC, Linfert DR, Galphin CM, Athreya BP, Nossuli AK, Chang IJ, Blumenthal SS, Manley J, Zeig S, Kant KS, Olivero JJ, Greene T, Dwyer JP, Collaborative Study Group (2015) Ferric citrate controls phosphorus and delivers iron in patients on dialysis. J Am Soc Nephrol 26:493–503
doi: 10.1681/ASN.2014020212
Umanath K, Jalal DI, Greco BA, Umeukeje EM, Reisin E, Manley J, Zeig S, Negoi DG, Hiremath AN, Blumenthal SS, Sika M, Niecestro R, Koury MJ, Ma KN, Greene T, Lewis JB, Dwyer JP, Collaborative Study Group (2015) Ferric citrate reduces intravenous iron and erythropoiesis-stimulating agent use in ESRD. J Am Soc Nephrol 26:2578–2587
doi: 10.1681/ASN.2014080842
Yokoyama K, Akiba T, Fukagawa M, Nakayama M, Sawada K, Kumagai Y, Chertow GM, Hirakata H (2014) A randomized trial of JTT-751 versus sevelamer hydrochloride in patients on hemodialysis. Nephrol Dial Transplant 29:1053–1060
doi: 10.1093/ndt/gft483
Floege J, Covic AC, Ketteler M, Rastogi A, Chong EM, Gaillard S, Lisk LJ, Sprague SM, PA21 Study Group (2014) A phase III study of the efficacy and safety of a novel iron-based phosphate binder in dialysis patients. Kidney Int 86:638–647
doi: 10.1038/ki.2014.58
Koiwa F, Yokoyama K, Fukagawa M, Akizawa T (2017) Long-term assessment of the safety and efficacy of PA21 (sucroferric oxyhydroxide) in Japanese hemodialysis patients with hyperphosphatemia: an open-label, multicenter, phase III study. J Ren Nutr 27:346–354
doi: 10.1053/j.jrn.2017.02.007
Hain DJ, Marinaro M, Koeper DW, Rosenthal MA, Chillemi S, Huffman JM, Gerbeling T, Pritsiolas JM, Loram LC, Pergola PE (2017) Ferric citrate controls serum phosphorus in dialysis patients: retrospective data. Clin Nephrol 88:12–18
doi: 10.5414/CN109057
Coyne DW, Ficociello LH, Parameswaran V, Anderson L, Vemula S, Ofsthun NJ, Mullon C, Maddux FW, Kossmann RJ, Sprague SM (2017) Real-world effectiveness of sucroferric oxyhydroxide in patients on chronic hemodialysis: a retrospective analysis of pharmacy data. Clin Nephrol 88:59–67
doi: 10.5414/CN109021
Lioulios G, Stangou M, Sarafidis PA, Tsouchnikas I, Minasidis I, Vainas A, Faitatzidou D, Sampani E, Papagianni A (2020) Chronic therapy with sucroferric oxyhydroxide does not affect iron and anemia markers in dialysis patients. Blood Purif 49:440–447
doi: 10.1159/000505432
Kendrick J, Parameswaran V, Ficociello LH, Ofsthun NJ, Davis S, Mullon C, Kossmann RJ, Kalantar-Zadeh K (2019) One-year historical cohort study of the phosphate binder sucroferric oxyhydroxide in patients on maintenance hemodialysis. J Ren Nutr 29:428–437
doi: 10.1053/j.jrn.2018.11.002
Payne RB, Little AJ, Williams RB, Milner JR (1973) Interpretation of serum calcium in patients with abnormal serum proteins. Br Med J 4:643–646
doi: 10.1136/bmj.4.5893.643
Yoshida T, Hayashi M (2017) Anemia treatment by erythropoiesis-stimulating agents during the 6 months before the initiation of hemodialysis: comparison of darbepoetin alfa and continuous erythropoietin receptor activator. Keio J Med 66:44–50
doi: 10.2302/kjm.2016-0009-OA
Yoshida T, Yamashita M, Hayashi M (2012) Krüppel-like factor 4 contributes to high phosphate-induced phenotypic switching of vascular smooth muscle cells into osteogenic cells. J Biol Chem 287:25706–25714
doi: 10.1074/jbc.M112.361360
Yoshida T, Yamashita M, Horimai C, Hayashi M (2013) High glucose concentration does not modulate the formation of arterial medial calcification in experimental uremic rats. J Vasc Res 50:512–520
doi: 10.1159/000355263
Yoshida T, Yamashita M, Horimai C, Hayashi M (2017) Smooth muscle-selective nuclear factor-κB inhibition reduces phosphate-induced arterial medial calcification in mice with chronic kidney disease. J Am Heart Assoc 6:e007248
doi: 10.1161/JAHA.117.007248
Kuragano T, Matsumura O, Matsuda A, Hara T, Kiyomoto H, Murata T, Kitamura K, Fujimoto S, Hase H, Joki N, Fukatsu A, Inoue T, Itakura I, Nakanishi T (2014) Association between hemoglobin variability, serum ferritin levels, and adverse events/mortality in maintenance hemodialysis patients. Kidney Int 86:845–854
doi: 10.1038/ki.2014.114
Kuo KL, Hung SC, Lin YP, Tang CF, Lee TS, Lin CP, Tarng DC (2012) Intravenous ferric chloride hexahydrate supplementation induced endothelial dysfunction and increased cardiovascular risk among hemodialysis patients. PLoS ONE 7:e50295
doi: 10.1371/journal.pone.0050295
Bailie GR, Larkina M, Goodkin DA, Li Y, Pisoni RL, Bieber B, Mason N, Tong L, Locatelli F, Marshall MR, Inaba M, Robinson BM (2015) Data from the Dialysis Outcomes and Practice Patterns Study validate an association between high intravenous iron doses and mortality. Kidney Int 87:162–168
doi: 10.1038/ki.2014.275
Litton E, Xiao J, Ho KM (2013) Safety and efficacy of intravenous iron therapy in reducing requirement for allogeneic blood transfusion: systematic review and meta-analysis of randomised clinical trials. BMJ 347:f4822
doi: 10.1136/bmj.f4822
Yamamoto H, Nishi S, Tomo T, Masakane I, Saito K, Nangaku M, Hattori M, Suzuki T, Morita S, Ashida A, Ito Y, Kuragano T, Komatsu Y, Sakai K, Tsubakihara Y, Tsuruya K, Hayashi T, Hirakata H, Honda H (2017) 2015 Japanese Society for Dialysis Therapy: guidelines for renal anemia in chronic kidney disease. Ren Replace Ther 3:36
doi: 10.1186/s41100-017-0114-y
Macdougall IC, White C, Anker SD, Bhandari S, Farrington K, Kalra PA, McMurray JJV, Murray H, Tomson CRV, Wheeler DC, Winearls CG, Ford I, PIVOTAL Investigators and Committees (2019) Intravenous iron in patients undergoing maintenance hemodialysis. N Engl J Med 380:447–458
doi: 10.1056/NEJMoa1810742
Nakayama M, Tani Y, Zhu WJ, Watanabe K, Yokoyama K, Fukagawa M, Akiba T, Wolf M, Hirakata H (2018) Oral ferric citrate hydrate associated with less oxidative stress than intravenous saccharated ferric oxide. Kidney Int Rep 3:364–373
doi: 10.1016/j.ekir.2017.10.016
Yokoyama K, Hirakata H, Akiba T, Sawada K, Kumagai Y (2012) Effect of oral JTT-751 (ferric citrate) on hyperphosphatemia in hemodialysis patients: results of a randomized, double-blind, placebo-controlled trial. Am J Nephrol 36:478–487
doi: 10.1159/000344008
Minakuchi H, Yoshida T, Kaburagi N, Fujino T, Endo S, Takemitsu TY, Yamashita N, Itoh H, Oya M (2020) Proton pump inhibitors may hinder hypophosphatemic effect of lanthanum carbonate, but not of ferric citrate hydrate or sucroferric oxyhydroxide, in hemodialysis patients. Ren Fail 42:799–806
doi: 10.1080/0886022X.2020.1803085
Amano H, Ohno Y, Inoue T, Tomori K, Ohama K, Okada H (2019) Regional prescription surveillance of phosphate binders in the western Saitama area: the substantial role of ferric citrate hydrate in improving serum phosphorus levels and erythropoiesis. Clin Exp Nephrol 23:841–851
doi: 10.1007/s10157-019-01715-8