A Phase III, randomized, open-label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy

American Journal of Hematology

Volumn 89, Issue 6, 2014, Pages 646-650

  Hetzel, David ^a   Strauss, William ^b   Bernard, Kristine ^b   Li, Zhu ^b   Urboniene, Audrone ^c   Allen, Lee F ^b  

^a ROYAL ADELAIDE HOSPITAL   (Australia)

^b AMAG PHARMACEUTICALS INC   (United States)

^c Saules Family Medicine Center   (Lithuania)

Author keywords

[No Author keywords available]

Indexed keywords

FERRITIN; FERUMOXYTOL; HEMOGLOBIN; IRON; IRON SACCHARATE; TRANSFERRIN;

ADULT; ANGIONEUROTIC EDEMA; ARTICLE; CARDIOVASCULAR DISEASE; CONTROLLED STUDY; DRUG EFFICACY; DRUG ERUPTION; DRUG FATALITY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HEART FAILURE; HEART INFARCTION; HUMAN; HYPERTENSION; HYPOTENSION; IMMUNOREACTIVITY; IRON DEFICIENCY ANEMIA; IRON THERAPY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; TACHYCARDIA; TREATMENT DURATION; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT; UTERUS BLEEDING;

ANEMIA, IRON-DEFICIENCY; FEMALE; FERRIC COMPOUNDS; FERROSOFERRIC OXIDE; GLUCARIC ACID; HUMANS; INJECTIONS, INTRAVENOUS; MALE; MIDDLE AGED;

EID: 84900833291     PISSN: 03618609     EISSN: 10968652     Source Type: Journal    
DOI: 10.1002/ajh.23712     Document Type: Article

References (37)

1. World Health Organization. Worldwide Prevalence of Anaemia 1993-2005: WHO Global Database on Anaemia. Geneva: World Health Organization; 2008.
2. Looker AC, Dallman PR, Carroll MD, et al. Prevalence of iron deficiency in the United States. JAMA 1997;277:973-976.
3. Smith RE Jr. The clinical and economic burden of anemia. Am J Manag Care 2010;16:S59-S66.
4. Croker JR, Beynon G. Gastro-intestinal bleeding-A major cause of iron deficiency in the elderly. Age Ageing 1981;10:40-43.
5. Niv E, Elis A, Zissin R, et al. Iron deficiency anemia in patients without gastrointestinal symptoms-A prospective study. Fam Pract 2005;22:58-61.
6. Bermejo F, Garcia-Lopez S. A guide to diagnosis of iron deficiency and iron deficiency anemia in digestive diseases. World J Gastroenterol 2009;15:4638-4643.
7. Bayraktar UD, Bayraktar S. Treatment of iron deficiency anemia associated with gastrointestinal tract diseases. World J Gastroenterol 2010;16:2720-2725.
8. Wells CW, Lewis S, Barton JR, Corbett S. Effects of changes in hemoglobin level on quality of life and cognitive function in inflammatory bowel disease patients. Inflamm Bowel Dis 2006;12:123-130.
9. World Health Organization. Iron deficiency anaemia: Assessment, prevention, and control: A guide for programme managers. Geneva, Switzerland: World Health Organization; 2001. p 114.
10. de Silva AD, Tsironi E, Feakins RM, Rampton DS. Efficacy and tolerability of oral iron therapy in inflammatory bowel disease: A prospective, comparative trial. Aliment Pharmacol Ther 2005;22:1097-1105.
11. Provenzano R, Schiller B, Rao M, et al. Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients. Clin J Am Soc Nephrol 2009;4:386-393.
12. Vifor. Venofer solution for injection or concentrate for solution for infusion: Summary of product characteristics. 2013. http://www.medicines.org.uk/emc/medicine/24168/SPC/Venofer+(iron+sucrose)/.
13. Barton JC, Barton EH, Bertoli LF et al. Intravenous iron dextran therapy in patients with iron deficiency and normal renal function who failed to respond to or did not tolerate oral iron supplementation. Am J Med 2000;109:27-32.
14. ® (iron dextran injection USP): US Prescribing Information. Morristown, NY: Watson Pharma Inc.; 2009.
15. Electronic Medicines Compendium (eMC). Cosmofer. Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/medicine/14139/SPC/CosmoFer. (accessed 21 Jan 2014).
16. Medicines and Healthcare Products Regulatory Agency. Intravenous iron and serious hypersensitivity reactions: New strengthened recommendations to manage and minimise risk. Drug Safety Update vol 7, issue 1 August 2013: A1. Available at: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON300398. (accessed 21 Jan 2014).
17. Auerbach M, Rodgers GM. Intravenous iron. N Engl J Med 2007;357:93-94.
18. Feraheme (ferumoxytol) Injection for Intravenous (IV) Use: US Prescribing Information. Lexington, MA: AMAG Pharmaceuticals Inc.; 2009.
19. Rosner MH, Auerbach M. Ferumoxytol for the treatment of iron deficiency. Expert Rev Hematol 2011;4:399-406.
20. Pai AB, Garba AO. Ferumoxytol: A silver lining in the treatment of anemia of chronic kidney disease or another dark cloud? J Blood Med 2012;3:77-85.
21. Evstatiev R, Marteau P, Iqbal T, et al. FERGIcor, a randomized controlled trial on ferric carboxymaltose for iron deficiency anemia in inflammatory bowel disease. Gastroenterology 2011;141:846-853, e841-e842.
22. Bisbe E, Garcia-Erce JA, Diez-Lobo AI, Munoz M. A multicentre comparative study on the efficacy of intravenous ferric carboxymaltose and iron sucrose for correcting preoperative anaemia in patients undergoing major elective surgery. Br J Anaesthesia 2011;107:477-478.
23. 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;54:306-315.
24. Vadhan-Raj S, Strauss W, Ford D, et al. Efficacy and safety of IV ferumoxytol for adults with iron deficiency anemia previously unresponsive to or unable to tolerate oral iron. Am J Hematol 2014;89:7-12.
25. Venofer (iron sucrose injection, USP): US Prescribing Information. Shirley, NY: American Regent Inc.; 2011.
26. Smith E, Lai JS, Cella D. Building a measure of fatigue: The functional assessment of chronic illness therapy fatigue scale. Pm R 2010;2:359-363.
27. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-483.
28. Cella D, Eton DT, Lai JS, et al. Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) anemia and fatigue scales. J Pain Symptom Manage 2002;24:547-561.
29. Patrick DL, Gagnon DD, Zagari MJ, et al. Assessing the clinical significance of health-related quality of life (HrQOL) improvements in anaemic cancer patients receiving epoetin alfa. Eur J Cancer 2003;39:335-345.
30. Bjorner JB, Wallenstein GV, Martin MC, et al. Interpreting score differences in the SF-36 Vitality scale: Using clinical conditions and functional outcomes to define the minimally important difference. Curr Med Res Opin 2007;23:731-739.
31. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: The remarkable universality of half a standard deviation. Med Care 2003;41:582-592.
32. Singh A, Patel T, Hertel J, et al. Safety of ferumoxytol in patients with anemia and CKD. Am J Kidney Dis 2008;52:907-915.
33. Spinowitz BS, Kausz AT, Baptista J, et al. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol 2008;19:1599-1605.
34. Schwenk MH. Ferumoxytol: A new intravenous iron preparation for the treatment of iron deficiency anemia in patients with chronic kidney disease. Pharmacotherapy 2010;30:70-79.
35. McCormack PL. Ferumoxytol: In iron deficiency anaemia in adults with chronic kidney disease. Drugs 2012;72:2013-2022.
36. Rawal A, Katsulis P, Stutz L, et al. Comparison of intravenous iron therapy for the treatment of anemia in CKD. Presented at the National Kidney Foundation Spring Clinical Meeting, Lake Buena Vista, FL, April 2-6, 2013.
37. Spinowitz BS, Schwenk MH, Jacobs PM, et al. The safety and efficacy of ferumoxytol therapy in anemic chronic kidney disease patients. Kidney Int 2005;68:1801-1807.