TY - JOUR
T1 - Intravenous ferric carboxymaltose in iron-Deficient chronic heart failure patients with and without anaemia
T2 - A subanalysis of the FAIR-HF trial
AU - Filippatos, Gerasimos
AU - Farmakis, Dimitrios
AU - Colet, Josep Comin
AU - Dickstein, Kenneth
AU - Lüscher, Thomas F.
AU - Willenheimer, Ronnie
AU - Parissis, John
AU - Gaudesius, Giedrius
AU - Mori, Claudio
AU - Rothe, Barbara Von Eisenhart
AU - Greenlaw, Nicola
AU - Ford, Ian
AU - Ponikowski, Piotr
AU - Anker, Stefan D.
PY - 2013
Y1 - 2013
N2 - 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 2 or 3, LVEF ≤40% (NYHA 2) or ≤45% (NYHA 3)] 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 forPGA and 1.90 vs. 3.39, P = 0.51 for NYHA). Resultswere 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.
AB - 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 2 or 3, LVEF ≤40% (NYHA 2) or ≤45% (NYHA 3)] 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 forPGA and 1.90 vs. 3.39, P = 0.51 for NYHA). Resultswere 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.
KW - Anaemia
KW - Ferric carboxymaltose
KW - Heart failure
KW - Intravenous iron
KW - Iron deficiency
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U2 - 10.1093/eurjhf/hft099
DO - 10.1093/eurjhf/hft099
M3 - Article
C2 - 23787722
AN - SCOPUS:84890044082
VL - 15
SP - 1267
EP - 1276
JO - European Journal of Heart Failure
JF - European Journal of Heart Failure
SN - 1388-9842
IS - 11
ER -