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January 31, 2012European Heart Journal170 citationsOpen Access

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

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JCJosep Comín‐ColetMLMitja LainščakKDKenneth Dickstein

Key Result

Intravenous ferric carboxymaltose significantly improved health-related quality of life (KCCQ overall, clinical, and total symptom scores) compared to placebo in patients with CHF (P<0.001).

Study Design

Type

RCT (n=459)

Randomization

2:1

Structured PICO

Does intravenous ferric carboxymaltose improve health-related quality of life in patients with chronic heart failure and iron deficiency?

P
Population
n=459 patients with chronic heart failure (reduced left ventricular ejection fraction) and iron deficiency, with or without anaemia
I
Intervention
Intravenous ferric carboxymaltose (FCM)
C
Comparator
Placebo
O
Outcome
Health-related quality of life (HRQoL) assessed using the generic EQ-5D questionnaire and disease-specific Kansas City cardiomyopathy questionnaire (KCCQ) at 4, 12, and 24 weekspatient reported

Intravenous ferric carboxymaltose significantly improves health-related quality of life in patients with chronic heart failure and iron deficiency, independent of anaemia status.

Main Result

p-value: p=< 0.001

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.

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Cite This Study

Comín‐Colet et al. (2012) conducted an RCT in chronic heart failure and iron deficiency (n=459). intravenous ferric carboxymaltose vs. placebo was evaluated on mean differences from baseline in KCCQ overall, clinical and total symptom scores (p=< 0.001). Intravenous ferric carboxymaltose significantly improved health-related quality of life (KCCQ overall, clinical, and total symptom scores) compared to placebo in patients with CHF (P<0.001).

synapsesocial.com/papers/6a08aa911e8b9db648de22bfhttps://doi.org/10.1093/eurheartj/ehr504
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Also Consider

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  1. 1Self-Rated Health and Mortality in Patients with Chronic Heart Failure2009 · 63 citations
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