Ferric Carboxymaltose in Patients With HF and Iron Deficiency
Ferric Carboxymaltose in Patients With HF and Iron Deficiency
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.
Patients with chronic heart failure (CHF) suffer from a marked impairment of health-related quality of life (HRQoL) compared with the normal population and patients with other chronic conditions. Among the factors associated with a reduced HRQoL, dyspnoea and fatigue are major symptoms of CHF that persist in many patients despite optimal drug and device management. Limited options for treatment of underlying CHF pathology have caused the focus of therapeutic attention to shift towards patient-centred outcomes such as HRQoL, particularly in those already receiving evidence-based therapy and even more so in those with limited life expectancy. Currently, an improvement in patient-reported outcomes is considered one of the main goals of comprehensive CHF management. Moreover, despite their benefits in survival, some of the usual therapies used in CHF, such as beta-blockers, have failed to prove a positive effect in terms of HRQoL.
Iron plays a vital role in energy-dependent physiological processes such as erythropoiesis and oxidative phosphorylation, and iron deficiency (ID) may be a frequent and significant comorbidity in CHF. Beyond anaemia, ID is a determinant of fatigue and impaired exercise capacity in otherwise healthy populations. In this context, there is recent evidence that ID in CHF patients is also associated with impaired exercise capacity, worse functional New York Heart Association (NYHA) class, and poorer outcomes, although this latter observation remains controversial. Iron deficiency is, therefore, a potential treatment target to improve HRQoL in CHF patients.
Beyond small studies, there is little information about HRQoL in iron-deficient CHF patients and the potential benefits of iron repletion therapy. The FAIR-HF study (Ferric carboxymaltose Assessment in patients with IRon deficiency and chronic Heart Failure) was designed to determine the effects of intravenous (i.v.) ferric carboxymaltose (FCM) in iron-deficient CHF patients. Ferric carboxymaltose was well tolerated and significantly improved CHF symptoms, exercise capacity, and HRQoL. In the current study, we undertook a detailed subanalysis of FAIR-HF to gain specific insight into the effects of FCM on different domains of HRQoL in iron-deficient CHF patients.
Abstract and Introduction
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.
Introduction
Patients with chronic heart failure (CHF) suffer from a marked impairment of health-related quality of life (HRQoL) compared with the normal population and patients with other chronic conditions. Among the factors associated with a reduced HRQoL, dyspnoea and fatigue are major symptoms of CHF that persist in many patients despite optimal drug and device management. Limited options for treatment of underlying CHF pathology have caused the focus of therapeutic attention to shift towards patient-centred outcomes such as HRQoL, particularly in those already receiving evidence-based therapy and even more so in those with limited life expectancy. Currently, an improvement in patient-reported outcomes is considered one of the main goals of comprehensive CHF management. Moreover, despite their benefits in survival, some of the usual therapies used in CHF, such as beta-blockers, have failed to prove a positive effect in terms of HRQoL.
Iron plays a vital role in energy-dependent physiological processes such as erythropoiesis and oxidative phosphorylation, and iron deficiency (ID) may be a frequent and significant comorbidity in CHF. Beyond anaemia, ID is a determinant of fatigue and impaired exercise capacity in otherwise healthy populations. In this context, there is recent evidence that ID in CHF patients is also associated with impaired exercise capacity, worse functional New York Heart Association (NYHA) class, and poorer outcomes, although this latter observation remains controversial. Iron deficiency is, therefore, a potential treatment target to improve HRQoL in CHF patients.
Beyond small studies, there is little information about HRQoL in iron-deficient CHF patients and the potential benefits of iron repletion therapy. The FAIR-HF study (Ferric carboxymaltose Assessment in patients with IRon deficiency and chronic Heart Failure) was designed to determine the effects of intravenous (i.v.) ferric carboxymaltose (FCM) in iron-deficient CHF patients. Ferric carboxymaltose was well tolerated and significantly improved CHF symptoms, exercise capacity, and HRQoL. In the current study, we undertook a detailed subanalysis of FAIR-HF to gain specific insight into the effects of FCM on different domains of HRQoL in iron-deficient CHF patients.
