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

Abstract

Aims: 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.

Methods and 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.

Figure 1

Percentage of iron-deficient chronic heart failure patients treated with ferric carboxymaltose or placebo reporting at least a minimally important difference in EQ-5D index score at each study time point [minimally important difference is the smallest index score change meaningful for health professionals, patients and other stakeholders, and is 0.074 (7.4%) for the EQ-5D index score].^,

Figure 2

Percentage of iron-deficient chronic heart failure patients treated with ferric carboxymaltose or placebo reporting improvement or deterioration in health-related quality of life at study Week 24 as measured using the Kansas City Cardiomyopathy Questionnaire (A) overall summary score, (B) overall clinical score, and (C) total symptom score.

Figure 3

Effect of ferric carboxymaltose on Kansas City Cardiomyopathy Questionnaire overall summary score among pre-specified subgroups in the FAIR-HF study population. CHF, chronic heart failure; FCM, ferric carboxymaltose; GFR, glomerular filtration rate; HRQoL, health-related quality of life; KCCQ, Kansas City Cardiomyopathy Questionnaire; NYHA, New York Heart Association.

Figure 4

Effect (mean ± SE) of ferric carboxymaltose on (A) Kansas City Cardiomyopathy Questionnaire clinical summary score (CSS; integrates total symptom score and physical limitation domain) and (B) Kansas City Cardiomyopathy Questionnaire quality of life domain among anaemic and non-anaemic subjects in the FAIR-HF study population.