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Title: The effect of intravenous ferric carboxymaltose on health-related quality of life in iron-deficient patients with acute heart failure: the results of the AFFIRM-AHF study
Author: Jankowska, Ewa A.
Kirwan, Bridget-Anne
Kosiborod, Mikhail
Butler, Javed
Anker, Stefan D.
McDonagh, Theresa
Dorobantu, Maria
Drozdz, Jarosław
Filippatos, Gerasimos
Keren, Andre
Khintibidze, Irakli
Kragten, Hans
Martínez, Felipe A.
Metra, Marco
Milicic, Davor
Nicolau, José C.
Ohlsson, Marcus
Parkhomenko, Alexander
Pascual Figal, Domingo
Ruschitzka, Frank
Sim, David
Skouri, Hadi
Van der Meer, Peter
Lewis, Basil S.
Comín Colet, Josep
Von Haehling, Stephan
Cohen-Solal, Alain
Danchin, Nicolas
Doehner, Wolfram
Dargie, Henry J.
Motro, Michael
Friede, Tim
Fabien, Vincent
Dorigotti, Fabio
Pocock, Stuart
Ponikowski, Piotr
Keywords: Malalties del cor
Dèficit de ferro
Heart diseases
Iron deficiency diseases
Issue Date: 3-Jun-2021
Publisher: Oxford University Press (OUP)
Abstract: Aims: Patients with heart failure (HF) and iron deficiency experience poor health-related quality of life (HRQoL). We evaluated the impact of intravenous (IV) ferric carboxymaltose (FCM) vs. placebo on HRQoL for the AFFIRM-AHF population. Methods and results: The baseline 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12), which was completed for 1058 (535 and 523) patients in the FCM and placebo groups, respectively, was administered prior to randomization and at Weeks 2, 4, 6, 12, 24, 36, and 52. The baseline KCCQ-12 overall summary score (OSS) mean ± standard error was 38.7 ± 0.9 (FCM group) and 37.1 ± 0.8 (placebo group); corresponding values for the clinical summary score (CSS) were 40.9 ± 0.9 and 40.1 ± 0.9. At Week 2, changes in OSS and CSS were similar for FCM and placebo. From Week 4 to Week 24, patients assigned to FCM had significantly greater improvements in OSS and CSS scores vs. placebo [adjusted mean difference (95% confidence interval, CI) at Week 4: 2.9 (0.5-5.3, P = 0.018) for OSS and 2.8 (0.3-5.3, P = 0.029) for CSS; adjusted mean difference (95% CI) at Week 24: 3.0 (0.3-5.6, P = 0.028) for OSS and 2.9 (0.2-5.6, P = 0.035) for CSS]. At Week 52, the treatment effect had attenuated but remained in favour of FCM. Conclusion: In iron-deficient patients with HF and left ventricular ejection fraction ≤50% who had stabilized after an episode of acute HF, treatment with IV FCM, compared with placebo, results in clinically meaningful beneficial effects on HRQoL as early as 4 weeks after treatment initiation, lasting up to Week 24.
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It is part of: European Heart Journal, 2011, vol. 42, num. 31, p. 3011-3020
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ISSN: 1522-9645
Appears in Collections:Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

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