The effect of intravenous ferric carboxymaltose on health-related quality of life in patients with chronic heart failure and iron deficiency: a subanalysis of the FAIR-HF study.
OBJECTIVE
Patients with chronic heart failure (CHF) show impaired health-related quality of life (HRQoL), an important target for therapeutic intervention. Impaired iron homeostasis may be one mechanism underlying the poor physical condition of CHF patients. This detailed subanalysis of the previously published FAIR-HF study evaluated baseline HRQoL in iron-deficient patients with CHF and the effect of intravenous ferric carboxymaltose (FCM) on HRQoL.


RESULTS
FAIR-HF randomized 459 patients with reduced left ventricular ejection fraction and iron deficiency, with or without anaemia, to FCM or placebo (2:1). Health-related quality of life was assessed at baseline and after 4, 12, and 24 weeks of therapy using the generic EQ-5D questionnaire and disease-specific Kansas City cardiomyopathy questionnaire (KCCQ). Baseline mean visual analogue scale (VAS) score was 54.3 ± 16.4 and KCCQ overall summary score was 52.4 ± 18.8. Ferric carboxymaltose significantly improved VAS and KCCQ (mean differences from baseline in KCCQ overall, clinical and total symptom scores, P< 0.001 vs. placebo) at all time points. At week 24, significant improvement vs. placebo was observed in four of the five EQ-5D dimensions: mobility (P= 0.004), self-care (P< 0.001), pain/discomfort (P= 0.006), anxiety/depression (P= 0.012), and usual activity (P= 0.035). Ferric carboxymaltose improved all KCCQ domain mean scores from Week 4 onward (P≤ 0.05), except for self-efficacy and social limitation. Effects were present in both anaemic and non-anaemic patients.


CONCLUSIONS
HRQoL is impaired in iron-deficient patients with CHF. Intravenous FCM significantly improved HRQoL after 4 weeks, and throughout the remaining study period. The positive effects of FCM were independent of anaemia status.
Heart Failure Programme, Department of Cardiology, and Research in Inflammatory and Cardiovascular Disorders Programme, IMIM-Hospital del Mar (Parc de Salut Mar), Passeig Maritim, 25-29, 08003, Barcelona, Spain. jcomin@hospitaldelmar.cat
Josep
J
Comin-Colet
Mitja
M
Lainscak
Kenneth
K
Dickstein
Gerasimos S
GS
Filippatos
Patrick
P
Johnson
Thomas F
TF
Lüscher
Claudio
C
Mori
Ronnie
R
Willenheimer
Piotr
P
Ponikowski
Stefan D
SD
Anker
D000368:Aged; D018798:Anemia, Iron-Deficiency / Q000150:complications / Q000188:drug therapy*; D002908:Chronic Disease; D004311:Double-Blind Method; D005290:Ferric Compounds / Q000008:administration & dosage*; D006333:Heart Failure / Q000150:complications / Q000188:drug therapy*; D006397:Hematinics / Q000008:administration & dosage*; D006706:Homeostasis / Q000502:physiology; D006801:Humans; D007275:Injections, Intravenous; D000090463:Iron Deficiencies; D008320:Maltose / Q000008:administration & dosage / Q000031:analogs & derivatives*; D011788:Quality of Life; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000150:complications
D005290:Ferric Compounds; D006397:Hematinics; C522335:ferric carboxymaltose; D008320:Maltose