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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

Filippatos, Gerasimos; Farmakis, Dimitrios; Colet, Josep Comin; Dickstein, Kenneth; Luescher, Thomas F.; Willenheimer, Ronnie LU ; Parissis, John; Gaudesius, Giedrius; Mori, Claudio and Rothe, Barbara von Eisenhart, et al. (2013) In European Journal of Heart Failure 15(11). p.1267-1276
Abstract
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. 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... (More)
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. 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. 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. (Less)
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published
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keywords
Anaemia, Iron deficiency, Heart failure, Intravenous iron, Ferric, carboxymaltose
in
European Journal of Heart Failure
volume
15
issue
11
pages
1267 - 1276
publisher
Elsevier
external identifiers
  • wos:000326723200010
  • scopus:84890044082
ISSN
1879-0844
DOI
10.1093/eurjhf/hft099
language
English
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yes
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4513cd1b-aa16-4c80-9084-232ce98eb755 (old id 4200964)
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2014-01-02 16:42:34
date last changed
2019-06-09 03:17:48
@article{4513cd1b-aa16-4c80-9084-232ce98eb755,
  abstract     = {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. 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. 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.},
  author       = {Filippatos, Gerasimos and Farmakis, Dimitrios and Colet, Josep Comin and Dickstein, Kenneth and Luescher, Thomas F. and Willenheimer, Ronnie and Parissis, John and Gaudesius, Giedrius and Mori, Claudio and Rothe, Barbara von Eisenhart and Greenlaw, Nicola and Ford, Ian and Ponikowski, Piotr and Anker, Stefan D.},
  issn         = {1879-0844},
  keyword      = {Anaemia,Iron deficiency,Heart failure,Intravenous iron,Ferric,carboxymaltose},
  language     = {eng},
  number       = {11},
  pages        = {1267--1276},
  publisher    = {Elsevier},
  series       = {European Journal of Heart Failure},
  title        = {Intravenous ferric carboxymaltose in iron-deficient chronic heart failure patients with and without anaemia: a subanalysis of the FAIR-HF trial},
  url          = {http://dx.doi.org/10.1093/eurjhf/hft099},
  volume       = {15},
  year         = {2013},
}