Indirect methods of comparison of the safety of ferric derisomaltose, iron sucrose and ferric carboxymaltose in the treatment of iron deficiency anemia

Expert Review of Hematology

Volumn 13, Issue 2, 2020, Pages 187-195

  Pollock, Richard F ^a   Biggar, Patrick ^b  

^a Department of Health Economics and Outcomes Research   (United Kingdom)

^b KLINIKUM COBURG   (Germany)

Author keywords

Administration; Ferric derisomaltose; Intravenous; Iron; Iron deficiency anemia; Iron isomaltoside

Indexed keywords

FERRIC CARBOXYMALTOSE; IRON ISOMALTOSE; IRON SACCHARATE; DISACCHARIDE; FERRIC ION; MALTOSE;

ALLERGIC REACTION; ARTICLE; BAYES THEOREM; COMPARATIVE STUDY; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; HUMAN; IRON DEFICIENCY ANEMIA; PRIORITY JOURNAL; PROSPECTIVE STUDY; SYSTEMATIC REVIEW;

ANEMIA, IRON-DEFICIENCY; DISACCHARIDES; FERRIC COMPOUNDS; FERRIC OXIDE, SACCHARATED; HUMANS; MALTOSE; PROSPECTIVE STUDIES;

EID: 85078567877     PISSN: 17474086     EISSN: 17474094     Source Type: Journal    
DOI: 10.1080/17474086.2020.1709437     Document Type: Article

References (44)

1. Avni T, Bieber A, Steinmetz T, et al. Treatment of anemia in inflammatory bowel disease–systematic review and meta-analysis. PLoS One. 2013;8(12):e75540.
2. Bonovas S, Fiorino G, Allocca M, et al. intravenous versus oral iron for the treatment of anemia in inflammatory bowel disease: a systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2016;95(2):e2308.
3. Avni T, Leibovici L, Gafter-Gvili A., Iron supplementation for the treatment of chronic heart failure and iron deficiency: systematic review and meta-analysis. Eur J Heart Fail. 2012;14(4):423–429.
4. O’Lone EL, Hodson EM, Nistor I, et al. Parenteral versus oral iron therapy for adults and children with chronic kidney disease. Cochrane Database Syst Rev. 2019;2:CD007857.
5. Susantitaphong P, Alqahtani F, Jaber BL. Efficacy and safety of intravenous iron therapy for functional iron deficiency anemia in hemodialysis patients: a meta-analysis. Am J Nephrol. 2014;39(2):130–141.
6. Reveiz L, Gyte GM, Cuervo LG, et al. Treatments for iron-deficiency anaemia in pregnancy. Cochrane Database Syst Rev. 2011;2011(10):CD003094.
7. Chertow GM, Mason PD, Vaage-Nilsen O, et al. Update on adverse drug events associated with parenteral iron. Nephrol Dial Transplant. 2006;21(2):378–382.
8. Fletes R, Lazarus JM, Gage J, et al. Suspected iron dextran-related adverse drug events in hemodialysis patients. Am J Kidney Dis. 2001;37(4):743–749.
9. Chertow GM, Mason PD, Vaage-Nilsen O, et al. On the relative safety of parenteral iron formulations. Nephrol Dial Transplant. 2004;19(6):1571–1575.
10. Wysowski DK, Swartz L, Borders-Hemphill BV, et al. Use of parenteral iron products and serious anaphylactic-type reactions. Am J Hematol. 2010;85:650–656.
11. Pharmacosmos A/S. A trial comparing the incidence of hypophosphatemia in relation to treatment with iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency anaemia (IDA-04). NCT03238911. [cited 2019 Aug 22]. Available from: https://clinicaltrials.gov/ct2/show/NCT03238911
12. Pharmacosmos A/S. A Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia (IDA-05). NCT03237065. [cited 2019 Sep 5]. Available from: https://clinicaltrials.gov/ct2/show/NCT03237065
13. Ehlken B, Nathell L, Gohlke A, et al. Evaluation of the reported rates of severe hypersensitivity reactions associated with ferric carboxymaltose and iron (III) isomaltoside 1000 in europe based on data from eudravigilance and VigiBase™ between 2014 and 2017. Drug Saf. 2019;42(3):463−71.
14. Schaffalitzky de Muckadell P, Strom CC. Comment on ‘evaluation of the reported rates of severe hypersensitivity reactions associated with ferric carboxymaltose and iron(III) isomaltoside 1000 in Europe based on data from eudravigilance and vigibase™ between 2014 and 2017ʹ. Drug Saf. 2019;42(5):689–691.
15. OCEBM Levels of Evidence Working Group. The oxford levels of evidence 2. Oxford Centre for Evidence-Based Medicine. [cited 2019 Oct 14]. Available from: https://www.cebm.net/index.aspx?o=5653
16. Burns PB, Rohrich RJ, Chung KC. The levels of evidence and their role in evidence-based medicine. Plast Reconstr Surg. 2011;128(1):305–310.
17. Kalra PA, Bhandari S. Safety of intravenous iron use in chronic kidney disease. Curr Opin Nephrol Hypertens. 2016;25(6):529–535.
18. Adkinson NF, Strauss WE, Macdougall IC, et al. Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia: A randomized trial. Am J Hematol. 2018;93(5):683−90.
19. US Food and Drug Administration. Center for drug evaluation and research. Application number: 203565Orig1s000. Medical Review. [cited 2019 Oct 1]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203565Orig1s000MedR.pdf
20. Plummer M. JAGS: a program for analysis of bayesian graphical models using Gibbs sampling. Proceedings of the 3rd International Workshop on Distributed Statistical Computing (DSC 2003), March 20–22, Vienna, Austria. ISSN 1609-395X.
21. Brooks SP, Gelman A. General methods for monitoring convergence of iterative simulations. J Comput Graph Stat. 1998;7(4):434–455.
22. Clopper C, Pearson ES. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika. 1934;26(4):404–413.
23. Gybel-Brask M, Seeberg J, Thomsen LL, et al. Intravenous iron isomaltoside improves hemoglobin concentration and iron stores in female iron-deficient blood donors: a randomized double-blind placebo-controlled clinical trial. Transfusion. 2018;58(4):974–981.
24. Johansson PI, Rasmussen AS, Thomsen LL. Intravenous iron isomaltoside 1000 (Monofer®) reduces postoperative anaemia in preoperatively non-anaemic patients undergoing elective or subacute coronary artery bypass graft, valve replacement or a combination thereof: a randomized double-blind placebo-controlled clinical trial (the PROTECT trial). Vox Sang. 2015;109(3):257–266.
25. Hildebrandt P, Bruun N, Nielsen O. et al. Effects of administration of iron isomaltoside 1000 in patients with chronic heart failure. A pilot study. Transfus Altern Transfus Med. 2010;11(4):131–137.
26. Birgegård G, Henry D, Glaspy J, et al. A randomized noninferiority trial of intravenous iron isomaltoside versus oral iron sulfate in patients with nonmyeloid malignancies and anemia receiving chemotherapy: the PROFOUND trial. Pharmacotherapy. 2016;36(4):402–414.
27. Wikström B, Bhandari S, Barany P, et al. Iron isomaltoside 1000: a new intravenous iron for treating iron deficiency in chronic kidney disease. J Nephrol. 2011;24(5):589–596.
28. Kalra PA, Bhandari S, Saxena S, et al. A randomized trial of iron isomaltoside 1000 versus oral iron in non-dialysis-dependent chronic kidney disease patients with anaemia. Nephrol Dial Transplant. 2016;31(4):646–655.
29. Bhandari S, Kalra PA, Kothari J, et al. A randomized, open-label trial of iron isomaltoside 1000 (Monofer®) compared with iron sucrose (Venofer®) as maintenance therapy in haemodialysis patients. Nephrol Dial Transplant. 2015;30(9):1577–1589.
30. Pharmacosmos A/S. Iron isomaltoside and iron sucrose for the treatment of iron deficiency anemia in non-dialysis-dependent chronic kidney disease. NCT02940860. [cited 2019 Oct 1]. Available from: https://clinicaltrials.gov/ct2/show/NCT02940860
31. Pharmacosmos A/S. An extension trial to assess the safety of re-dosing of iron isomaltoside (Monofer®) (FerWonExt). October 1, 2019 [cited 2019 Sept5]. Available from: https://clinicaltrials.gov/ct2/show/NCT02962648
32. Reinisch W, Staun M, Tandon RK, et al. A randomized, open-label, non-inferiority study of intravenous iron isomaltoside 1,000 (Monofer) compared with oral iron for treatment of anemia in IBD (PROCEED). Am J Gastroenterol. 2013;108(12):1877–1888.
33. Reinisch W, Altorjay I, Zsigmond F, et al. A 1-year trial of repeated high-dose intravenous iron isomaltoside 1000 to maintain stable hemoglobin levels in inflammatory bowel disease. Scand J Gastroenterol. 2015;50(10):1226–1233.
34. Dahlerup JF, Jacobsen BA, van der Woude J, et al. High-dose fast infusion of parenteral iron isomaltoside is efficacious in inflammatory bowel disease patients with iron-deficiency anaemia without profound changes in phosphate or fibroblast growth factor 23. Scand J Gastroenterol. 2016;51(11):1332–1338.
35. Derman R, Roman E, Modiano MR, et al. A randomized trial of iron isomaltoside versus iron sucrose in patients with iron deficiency anemia. Am J Hematol. 2017;92(3):286–291.
36. Auerbach M, Henry D, Derman RJ, et al. A prospective, multi-center, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial. Am J Hematol. 2019;94:1007–1014. Online publication ahead of print.
37. Holm C, Thomsen LL, Norgaard A, et al. Intravenous iron isomaltoside 1000 administered by high single-dose infusions or standard medical care for the treatment of fatigue in women after postpartum haemorrhage: study protocol for a randomised controlled trial. Trials. 2015;16:5.
38. Pharmacosmos A/S. Treatment of women after severe postpartum haemorrhage (PP-02). NCT01895205. [cited 2019 September 5]. Available from: https://clinicaltrials.gov/ct2/show/NCT01895205
39. Onken JE, Bregman DB, Harrington RA, et al. Ferric carboxymaltose in patients with iron-deficiency anemia and impaired renal function: the REPAIR-IDA trial. Nephrol Dial Transplant. 2014;29(4):833–842.
40. Onken JE, Bregman DB, Harrington RA, et al. A multicenter, randomized, active-controlled study to investigate the efficacy and safety of intravenous ferric carboxymaltose in patients with iron deficiency anemia. Transfusion. 2014;54(2):306–315.
41. Wolf M, Rubin J, Achebe M, et al. OR13-3 effects of iron isomaltoside versus ferric carboxymaltose on hormonal control of phosphate homeostasis: the PHOSPHARE-IDA04/05 randomized controlled trials. J Endocr Soc. 2019;3(Suppl 1):OR13–3.
42. Nathell L, Gohlke A, Wohlfeil S. Reported severe hypersensitivity reactions after intravenous iron administration in the European Economic Area (EEA) before and after implementation of risk minimization measures. Drug Saf. 2019. Online publication ahead of print. DOI:10.1007/s40264-019-00868-5
43. Weber JCP. Epidemiology of adverse reactions to nonsteroidal anti-inflammatory drugs. In: Rainsford KD, Velo GD, editors. Side-effects of anti-inflammatory drugs, advances in inflammation research. New York: Raven Press; 1984:1–7.
44. Medical Dictionary for Regulatory Activities. Standardised MedDRA queries. [cited 2019 October 29]. Available from: https://www.meddra.org/standardised-meddra-queries