Ray, R. et al. (2023) The impact of ferric derisomaltose on cardiovascular and non-cardiovascular events in patients with anemia, iron deficiency and heart failure with reduced ejection fraction. Journal of Cardiac Failure, (doi: 10.1016/j.cardfail.2023.10.006) (PMID:37926238) (Early Online Publication)
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Abstract
Background: In some countries, intravenous (IV) ferric derisomaltose (FDI) is only licensed for treating iron deficiency with anemia. Accordingly, we investigated the effects of intravenous FDI in a subgroup of patients with anemia in the IRONMAN trial. Method and Results: IRONMAN enrolled patients with heart failure, left ventricular ejection fraction (LVEF) ≤45% and iron deficiency (ferritin <100 µg/L or TSAT <20%), 771 (68%) of whom had anemia (hemoglobin <12 g/dL for women; <13 g/dL for men). Patients were randomized, open-label, to FDI (n=397) or usual care (n=374) and followed for a median of 2.6 years. The primary endpoint, recurrent hospitalization for heart failure and cardiovascular death, occurred less frequently for those assigned to FDI (rate ratio 0.78 [95% CI 0.61 – 1.01); p=0.063). First-event analysis for cardiovascular death or hospitalization for heart failure, less affected by the COVID pandemic, gave similar results (hazard ratio 0.77 [95% CI 0.62 – 0.96]; p=0.022). Patients randomized to FDI reported a better Minnesota Living with Heart Failure quality-of-life, for overall (p = 0.013) and physical-domain (p = 0.00093) scores at four months. Conclusion: In patients with iron deficiency anemia and heart failure with reduced LVEF, IV FDI improves quality of life and may reduce cardiovascular events.
| Item Type: | Articles |
|---|---|
| Additional Information: | The study was funded by the British Heart Foundation (grant award CS/15/1/31175). Pharmacosmos provided supplies of intravenous ferric derisomaltose and additional trial support with an unrestricted grant. |
| Status: | Early Online Publication |
| Refereed: | Yes |
| Glasgow Author(s) Enlighten ID: | Graham, Dr Fraser and Cleland, Professor John and Kalra, Professor Paul and Petrie, Professor Mark and Pellicori, Dr Pierpaolo and Ford, Professor Ian |
| Authors: | Ray, R., Ford, I., Cleland, J. G.F., Graham, F., Ahmed, F. Z., Al-Mohammad, A., Cowburn, P. J., Critoph, C., Kalra, P. A., Lane, R. E., Ludman, A., Pellicori, P., Petrie, M. C., Robertson, M., Seed, A., Squire, I., and Kalra, P. R. |
| College/School: | College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre |
| Journal Name: | Journal of Cardiac Failure |
| Publisher: | Elsevier |
| ISSN: | 1071-9164 |
| ISSN (Online): | 1532-8414 |
| Published Online: | 03 November 2023 |
| Copyright Holders: | Copyright © 2023 The Authors |
| First Published: | First published in Journal of Cardiac Failure 2023 |
| Publisher Policy: | Reproduced under a Creative Commons License |
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