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Intravenous ferric carboxymaltose in iron‐deficient chronic heart failure patients with and without anaemia: a subanalysis of the FAIR‐HF trial
Author(s) -
Filippatos Gerasimos,
Farmakis Dimitrios,
Colet Josep Comin,
Dickstein Kenneth,
Lüscher Thomas F.,
Willenheimer Ronnie,
Parissis John,
Gaudesius Giedrius,
Mori Claudio,
Eisenhart Rothe Barbara,
Greenlaw Nicola,
Ford Ian,
Ponikowski Piotr,
Anker Stefan D.
Publication year - 2013
Publication title -
european journal of heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.149
H-Index - 133
eISSN - 1879-0844
pISSN - 1388-9842
DOI - 10.1093/eurjhf/hft099
Subject(s) - medicine , heart failure , clinical endpoint , placebo , iron deficiency , quality of life (healthcare) , ejection fraction , odds ratio , adverse effect , randomized controlled trial , gastroenterology , cardiology , anemia , alternative medicine , nursing , pathology
Aims 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. Methods and 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.