Ferumoxytol versus placebo in iron deficiency anemia: Efficacy, safety, and quality of life in patients with gastrointestinal disorders

Clinical and Experimental Gastroenterology

Volumn 9, Issue , 2016, Pages 151-162

  Ford, David C ^a   Dahl, Naomi V ^b   Strauss, William E ^b   Barish, Charles F ^c   Hetzel, David J ^d   Bernard, Kristine ^b   Li, Zhu ^b   Allen, Lee F ^b  

^a Toronto Digestive Disease Associates   (Canada)

^b AMAG PHARMACEUTICALS INC   (United States)

^c WAKE RESEARCH ASSOCIATES   (United States)

^d ROYAL ADELAIDE HOSPITAL   (Australia)

Author keywords

Efficacy; Hemoglobin; Inflammatory bowel disease; Intravenous iron; Patient reported outcomes; Quality of life

Indexed keywords

FERUMOXYTOL; HEMOGLOBIN; IRON; PLACEBO;

ABDOMINAL PAIN; ADULT; ANEMIA; ARTICLE; BACKACHE; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; FACE EDEMA; FATIGUE; FEMALE; FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY FATIGUE; FUNCTIONAL STATUS ASSESSMENT; GASTROINTESTINAL DISEASE; HEADACHE; HUMAN; HYPERSENSITIVITY; HYPOTENSION; IRON DEFICIENCY ANEMIA; LIMB PAIN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PATIENT ATTITUDE; PERIPHERAL EDEMA; PHASE 3 CLINICAL TRIAL; PRURITUS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SHORT FORM 36; STRIDOR; TREATMENT OUTCOME; URINARY TRACT INFECTION; VOMITING;

EID: 84978828582     PISSN: None     EISSN: 11787023     Source Type: Journal    
DOI: 10.2147/CEG.S101473     Document Type: Article

References (28)

1. Majid S, Salih M, Wasaya R, Jafri W. Predictors of gastrointestinal lesions on endoscopy in iron deficiency anemia without gastrointestinal symptoms. BMC Gastroenterol. 2008;8:52.
2. Niv E, Elis A, Zissin R, Naftali T, Novis B, Lishner M. Iron deficiency anemia in patients without gastrointestinal symptoms-a prospective study. Fam Pract. 2005;22(1):58-61.
3. Carter D, Levi G, Tzur D, Novis B, Avidan B. Prevalence and predictive factors for gastrointestinal pathology in young men evaluated for iron deficiency anemia. Dig Dis Sci. 2013;58(5):1299-1305.
4. Liu K, Kaffes AJ. Iron deficiency anaemia: a review of diagnosis, investigation and management. Eur J Gastroenterol Hepatol. 2012;24(2):109-116.
5. McCann JC, Ames BN. An overview of evidence for a causal relation between iron deficiency during development and deficits in cognitive or behavioral function. Am J Clin Nutr. 2007;85(4):931-945.
6. Bang SM, Lee JO, Kim YJ, et al. Anemia and activities of daily living in the Korean urban elderly population: results from the Korean Longitudinal Study on Health and Aging (KLoSHA). Ann Hematol. 2013;92(1):59-65.
7. Ando K, Morita S, Higashi T, et al. Health-related quality of life among Japanese women with iron-deficiency anemia. Qual Life Res. 2006;15(10):1559-1563.
8. Barton JC, Barton EH, Bertoli LF, Gothard CH, Sherrer JS. 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(1):27-32.
9. Kulnigg S, Gasche C. Systematic review: managing anaemia in Crohn’s disease. Aliment Pharmacol Ther. 2006;24(11-12):1507-1523.
10. Schroder O, Mickisch O, Seidler U, et al. Intravenous iron sucrose versus oral iron supplementation for the treatment of iron deficiency anemia in patients with inflammatory bowel disease-a randomized, controlled, open-label, multicenter study. Am J Gastroenterol. 2005;100(11):2503-2509.
11. Van Assche G, Dignass A, Bokemeyer B, et al; European Crohn’s and Colitis Organisation. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 3: special situations. J Crohns Colitis. 2013;7(1):1-33.
12. AMAG Pharmaceuticals, Inc. Feraheme (ferumoxytol) Injection [Prescribing Information]. Waltham, MA: AMAG Pharmaceuticals, Inc; 2015.
13. Jahn MR, Andreasen HB, Futterer S, et al. A comparative study of the physicochemical properties of iron isomaltoside 1000 (Monofer), a new intravenous iron preparation and its clinical implications. Eur J Pharm Biopharm. 2011;78(3):480-491.
14. 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(1):7-12.
15. Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997;13(2):63-74.
16. 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(6):473-483.
17. Patrick DL, Gagnon DD, Zagari MJ, Mathijs R, Sweetenham J, Epoetin Alfa Study Group. Assessing the clinical significance of health-related quality of life (HrQOL) improvements in anaemic cancer patients receiving epoetin alfa. Eur J Cancer. 2003;39(3):335-345.
18. Cella D, Eton DT, Lai JS, Peterman AH, Merkel DE. 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(6):547-561.
19. Cella D, Lai JS, Chang CH, Peterman A, Slavin M. Fatigue in cancer patients compared with fatigue in the general United States population. Cancer. 2002;94(2):528-538.
20. 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(5):582-592.
21. Hetzel D, Strauss W, Bernard K, Li Z, Urboniene A, Allen LF. 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. Am J Hematol. 2014;89(6):646-650.
22. Koutroubakis IE, Oustamanolakis P, Karakoidas C, Mantzaris GJ, Kouroumalis EA. Safety and efficacy of total-dose infusion of low molecular weight iron dextran for iron deficiency anemia in patients with inflammatory bowel disease. Dig Dis Sci. 2010;55(8):2327-2331.
23. Khalil A, Goodhand JR, Wahed M, Yeung J, Ali FR, Rampton DS. Efficacy and tolerability of intravenous iron dextran and oral iron in inflammatory bowel disease: a case-matched study in clinical practice. Eur J Gastroenterol Hepatol. 2011;23(11):1029-1035.
24. Kulnigg S, Stoinov S, Simanenkov V, et al. A novel intravenous iron formulation for treatment of anemia in inflammatory bowel disease: the ferric carboxymaltose (FERINJECT) randomized controlled trial. Am J Gastroenterol. 2008;103(5):1182-1192.
25. Lindgren S, Wikman O, Befrits R, et al. Intravenous iron sucrose is superior to oral iron sulphate for correcting anaemia and restoring iron stores in IBD patients: a randomized, controlled, evaluator-blind, multicentre study. Scand J Gastroenterol. 2009;44(7):838-845.
26. Hetzel D, Strauss W, Bernard K, Li J, Allen L. IV iron treatment of iron deficiency anaemia with ferumoxytol in patients with gastrointestinal disorders unable to take oral iron: a randomized controlled trial versus iron sucrose [Abstract P485]. J Crohns Colitis. 2013;7:S204.
27. Strauss W, Dahl NV, Vadhan-Raj S, et al. Effects of IV iron treatment with ferumoxytol on health related quality of life of patients with iron deficiency anemia. J Commun Support Oncol. In Press 2016.
28. Glaspy J, Bukowski R, Steinberg D, Taylor C, Tchekmedyian S, Vadhan-Raj S. Impact of therapy with epoetin alfa on clinical outcomes in patients with nonmyeloid malignancies during cancer chemotherapy in community oncology practice. Procrit Study Group. J Clin Oncol. 1997;15(3):1218-1234.