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

Jankowska, E. A. et al. (2021) 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. European Heart Journal, 42(31), pp. 3011-3020. (doi: 10.1093/eurheartj/ehab234) (PMID:34080008) (PMCID:PMC8370759)

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.

• Item Type: Articles
• Additional Information: The AFFIRM-AHF trial was funded by Vifor Pharma.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Dargie, Professor Henry
• Authors: Jankowska, E. A., Kirwan, B.-A., Kosiborod, M., Butler, J., Anker, S. D., McDonagh, T., Dorobantu, M., Drozdz, J., Filippatos, G., Keren, A., Khintibidze, I., Kragten, H., Martinez, F. A., Metra, M., Milicic, D., Nicolau, J. C., Ohlsson, M., Parkhomenko, A., Pascual-Figal, D. A., Ruschitzka, F., Sim, D., Skouri, H., van der Meer, P., Lewis, B. S., Comin-Colet, J., von Haehling, S., Cohen-Solal, A., Danchin, N., Doehner, W., Dargie, H. J., Motro, M., Friede, T., Fabien, V., Dorigotti, F., Pocock, S., and Ponikowski, P.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
• Journal Name: European Heart Journal
• Publisher: Oxford University Press
• ISSN: 0195-668X
• ISSN (Online): 1522-9645
• Published Online: 03 June 2021
• Copyright Holders: Copyright © 2021 The Authors
• First Published: First published in European Heart Journal 42(31): 3011-3020
• Publisher Policy: Reproduced under a Creative Commons License