TY - JOUR
T1 - The effect of intravenous ferric carboxymaltose on health-related quality of life in iron-deficient patients with acute heart failure
T2 - The results of the AFFIRM-AHF study
AU - Jankowska, Ewa A.
AU - Kirwan, Bridget Anne
AU - Kosiborod, Mikhail
AU - Butler, Javed
AU - Anker, Stefan D.
AU - McDonagh, Theresa
AU - Dorobantu, Maria
AU - Drozdz, Jarosław
AU - Filippatos, Gerasimos
AU - Keren, Andre
AU - Khintibidze, Irakli
AU - Kragten, Hans
AU - Martinez, Felipe A.
AU - Metra, Marco
AU - Milicic, Davor
AU - Nicolau, José C.
AU - Ohlsson, Marcus
AU - Parkhomenko, Alexander
AU - Pascual-Figal, Domingo A.
AU - Ruschitzka, Frank
AU - Sim, David
AU - Skouri, Hadi
AU - Van Der Meer, Peter
AU - Lewis, Basil S.
AU - Comin-Colet, Josep
AU - Von Haehling, Stephan
AU - Cohen-Solal, Alain
AU - Danchin, Nicolas
AU - Doehner, Wolfram
AU - Dargie, Henry J.
AU - Motro, Michael
AU - Friede, Tim
AU - Fabien, Vincent
AU - Dorigotti, Fabio
AU - Pocock, Stuart
AU - Ponikowski, Piotr
N1 - Publisher Copyright:
© 2021 The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.
PY - 2021/8/14
Y1 - 2021/8/14
N2 - 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.
AB - 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.
KW - Acute heart failure
KW - Health-related quality of life
KW - Heart failure
KW - Intravenous ferric carboxymaltose therapy
KW - Iron deficiency
KW - Randomized clinical trial
UR - http://www.scopus.com/inward/record.url?scp=85119822901&partnerID=8YFLogxK
U2 - 10.1093/eurheartj/ehab234
DO - 10.1093/eurheartj/ehab234
M3 - Article
C2 - 34080008
AN - SCOPUS:85119822901
SN - 0195-668X
VL - 42
SP - 3011
EP - 3020
JO - European Heart Journal
JF - European Heart Journal
IS - 31
ER -