title: Intravenous ferric carboxymaltose in iron-deficient chronic heart failure patients with and without anaemia: a subanalysis of the FAIR-HF trial.
abstract: OBJECTIVE
  Therapy with i.v. iron in patients with chronic heart failure (CHF) and iron deficiency (ID) improves symptoms, functional capacity, and quality of life. We sought to investigate whether these beneficial outcomes are independent of anaemia.
  
  
  RESULTS
  FAIR-HF randomized 459 patients with CHF [NYHA class II or III, LVEF ≤40% (NYHA II) or ≤45% (NYHA III)] and ID to i.v. iron as ferric carboxymaltose (FCM) or placebo in a 2:1 ratio. We analysed the efficacy and safety according to the presence or absence of anaemia (haemoglobin ≤120 g/L) at baseline. Of 459 patients, 232 had anaemia at baseline (51%). The effect of FCM on the primary endpoints of self-reported Patient Global Assessment (PGA) and NYHA class at week 24 was similar in patients with and without anaemia [odds ratio (OR) for improvement, 2.48 vs. 2.60, P = 0.97 for PGA and 1.90 vs. 3.39, P = 0.51 for NYHA). Results were also similar for the secondary endpoints, including PGA and NYHA at weeks 4 and 12, 6 min walk test distance, Kansas City Cardiomyopathy Questionnaire overall score, and European Quality of Life-5 Dimensions Visual Analogue Scale at most time points. Regarding safety, no differences were noticed in the rates of death or first hospitalization between FCM and placebo both in anaemic and in non-anaemic patients.
  
  
  CONCLUSIONS
  Treatment of ID with FCM in patients with CHF is equally efficacious and shows a similar favourable safety profile irrespective of anaemia. Iron status should be assessed in symptomatic CHF patients both with and without anaemia and treatment of ID should be considered.
authors.affiliation: Athens University Hospital Attikon, Athens, Greece.
authors.forename: Gerasimos
authors.initials: G
authors.lastname: Filippatos
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Farmakis
authors.forename: Josep Comin
authors.initials: JC
authors.lastname: Colet
authors.forename: Kenneth
authors.initials: K
authors.lastname: Dickstein
authors.forename: Thomas F
authors.initials: TF
authors.lastname: Lüscher
authors.forename: Ronnie
authors.initials: R
authors.lastname: Willenheimer
authors.forename: John
authors.initials: J
authors.lastname: Parissis
authors.forename: Giedrius
authors.initials: G
authors.lastname: Gaudesius
authors.forename: Claudio
authors.initials: C
authors.lastname: Mori
authors.forename: Barbara
authors.initials: B
authors.lastname: von Eisenhart Rothe
authors.forename: Nicola
authors.initials: N
authors.lastname: Greenlaw
authors.forename: Ian
authors.initials: I
authors.lastname: Ford
authors.forename: Piotr
authors.initials: P
authors.lastname: Ponikowski
authors.forename: Stefan D
authors.initials: SD
authors.lastname: Anker
mesh_terms: D061605:Administration, Intravenous; D000368:Aged; D018798:Anemia, Iron-Deficiency / Q000150:complications / Q000188:drug therapy*; D016022:Case-Control Studies; D002908:Chronic Disease; D003677:Deficiency Diseases / Q000150:complications / Q000188:drug therapy*; D005260:Female; D005290:Ferric Compounds / Q000627:therapeutic use*; D006333:Heart Failure / Q000150:complications*; D006397:Hematinics / Q000627:therapeutic use*; D006801:Humans; D000090463:Iron Deficiencies; D008297:Male; D008320:Maltose / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008875:Middle Aged; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D005290:Ferric Compounds; D006397:Hematinics; C522335:ferric carboxymaltose; D008320:Maltose
keywords: Anaemia; Ferric carboxymaltose; Heart failure; Intravenous iron; Iron deficiency