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
(2021) In European Heart Journal 42(31). p.3011-3020- 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... (More)
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.
(Less)
- 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
; Martinez, Felipe A
; Metra, Marco
; Milicic, Davor
; Nicolau, José C
; Ohlsson, Marcus
LU
; Parkhomenko, Alexander
; Pascual-Figal, Domingo A
; Ruschitzka, Frank
; Sim, David
; Skouri, Hadi
; van der Meer, Peter
; Lewis, Basil S
; Comin-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
and Ponikowski, Piotr
(Less) - author collaboration
- publishing date
- 2021-08-17
- type
- Contribution to journal
- publication status
- published
- keywords
- Humans, Anemia, Iron-Deficiency/drug therapy, Ferric Compounds/therapeutic use, Heart Failure/complications, Iron/therapeutic use, Maltose/therapeutic use, Quality of Life, Stroke Volume, Treatment Outcome, Ventricular Function, Left
- in
- European Heart Journal
- volume
- 42
- issue
- 31
- pages
- 3011 - 3020
- publisher
- Oxford University Press
- external identifiers
-
- pmid:34080008
- scopus:85119822901
- ISSN
- 1522-9645
- DOI
- 10.1093/eurheartj/ehab234
- language
- English
- LU publication?
- no
- additional info
- © The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.
- id
- 36b8b12c-09c8-4ce2-95c4-cfad34ff77dd
- date added to LUP
- 2025-05-27 07:47:19
- date last changed
- 2025-07-09 16:23:06
@article{36b8b12c-09c8-4ce2-95c4-cfad34ff77dd,
abstract = {{<p>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.</p><p>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.</p><p>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.</p>}},
author = {{Jankowska, Ewa A and Kirwan, Bridget-Anne and Kosiborod, Mikhail and Butler, Javed and Anker, Stefan D and McDonagh, Theresa and Dorobantu, Maria and Drozdz, Jarosław and Filippatos, Gerasimos and Keren, Andre and Khintibidze, Irakli and Kragten, Hans and Martinez, Felipe A and Metra, Marco and Milicic, Davor and Nicolau, José C and Ohlsson, Marcus and Parkhomenko, Alexander and Pascual-Figal, Domingo A and Ruschitzka, Frank and Sim, David and Skouri, Hadi and van der Meer, Peter and Lewis, Basil S and Comin-Colet, Josep and von Haehling, Stephan and Cohen-Solal, Alain and Danchin, Nicolas and Doehner, Wolfram and Dargie, Henry J and Motro, Michael and Friede, Tim and Fabien, Vincent and Dorigotti, Fabio and Pocock, Stuart and Ponikowski, Piotr}},
issn = {{1522-9645}},
keywords = {{Humans; Anemia, Iron-Deficiency/drug therapy; Ferric Compounds/therapeutic use; Heart Failure/complications; Iron/therapeutic use; Maltose/therapeutic use; Quality of Life; Stroke Volume; Treatment Outcome; Ventricular Function, Left}},
language = {{eng}},
month = {{08}},
number = {{31}},
pages = {{3011--3020}},
publisher = {{Oxford University Press}},
series = {{European Heart Journal}},
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}},
url = {{http://dx.doi.org/10.1093/eurheartj/ehab234}},
doi = {{10.1093/eurheartj/ehab234}},
volume = {{42}},
year = {{2021}},
}