title: Ferumoxytol versus placebo in iron deficiency anemia: efficacy, safety, and quality of life in patients with gastrointestinal disorders.
abstract: BACKGROUND
  Iron deficiency anemia (IDA) is common in patients with gastrointestinal (GI) disorders and can adversely affect quality of life. Oral iron is poorly tolerated in many patients with GI disorders. Ferumoxytol is approved for the intravenous treatment of IDA in patients with chronic kidney disease. This study aimed to evaluate the efficacy and safety of ferumoxytol in patients with IDA and concomitant GI disorders.
  
  
  METHODS
  This analysis included 231 patients with IDA and GI disorders from a Phase III, randomized, double-blind, placebo-controlled trial evaluating ferumoxytol (510 mg ×2) versus placebo in patients who had failed or were intolerant of oral iron therapy. The primary study end point was the proportion of patients achieving a ≥20 g/L increase in hemoglobin (Hgb) from baseline to Week 5. Other end points included mean change in Hgb, proportion of patients achieving Hgb ≥120 g/L, mean change in transferrin saturation, and patient-reported outcomes (PROs).
  
  
  RESULTS
  Significantly more patients with IDA receiving ferumoxytol achieved a ≥20 g/L increase in Hgb versus placebo (82.1% vs 1.7%, respectively; P<0.001). Mean increase in Hgb (28.0 g/L vs -1.0 g/L, respectively; P<0.001) significantly favored ferumoxytol treatment. Ferumoxytol-treated patients demonstrated significantly greater improvements than placebo-treated patients relative to their very poor baseline PRO scores posttreatment, including improvements in the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire and various domains of the 36-Item Short-Form Health Survey. Ferumoxytol-treated patients had a low rate of adverse events.
  
  
  CONCLUSIONS
  In this study, ferumoxytol was shown to be an efficacious and generally well-tolerated treatment option for patients with IDA and underlying GI disorders who were unable to use or had a history of unsatisfactory oral iron therapy.
authors.affiliation: Toronto Digestive Disease Associates, Inc, Vaughan Endoscopy Clinic, Vaughan, ON, Canada.
authors.forename: David C
authors.initials: DC
authors.lastname: Ford
authors.affiliation: AMAG Pharmaceuticals, Inc, Waltham, MA.
authors.forename: Naomi V
authors.initials: NV
authors.lastname: Dahl
authors.affiliation: AMAG Pharmaceuticals, Inc, Waltham, MA.
authors.forename: William E
authors.initials: WE
authors.lastname: Strauss
authors.affiliation: Wake Gastroenterology, Wake Research Associates, Raleigh, NC, USA.
authors.forename: Charles F
authors.initials: CF
authors.lastname: Barish
authors.affiliation: Department of Gastroenterology, Royal Adelaide Hospital, Adelaide, SA, Australia.
authors.forename: David J
authors.initials: DJ
authors.lastname: Hetzel
authors.affiliation: AMAG Pharmaceuticals, Inc, Waltham, MA.
authors.forename: Kristine
authors.initials: K
authors.lastname: Bernard
authors.affiliation: AMAG Pharmaceuticals, Inc, Waltham, MA.
authors.forename: Zhu
authors.initials: Z
authors.lastname: Li
authors.affiliation: AMAG Pharmaceuticals, Inc, Waltham, MA.
authors.forename: Lee F
authors.initials: LF
authors.lastname: Allen
keywords: efficacy; hemoglobin; inflammatory bowel disease; intravenous iron; patient-reported outcomes; quality of life