The impact of ferric derisomaltose on cardiovascular and non-cardiovascular events in patients with anemia, iron deficiency and heart failure with reduced ejection fraction

Department of Cardiology, St George's University Hospitals NHS Foundation Trust, London, UK; Molecular and Clinical Sciences Institute, St. George's University of London, United Kingdom (UK). Electronic address: rray@sgul.ac.uk. Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK. Electronic address: ian.ford@glasgow.ac.uk. School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK. Electronic address: john.cleland@glasgow.ac.uk. Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK. Electronic address: fraser.graham@doctors.org.uk. Department of Cardiology, Manchester University NHS Foundation Trust, Manchester, UK. Electronic address: Fozia.Ahmed@mft.nhs.uk. Department of Cardiology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK; Department of Infection, Immunity and Cardiovascular Disease, The University ofSheffield, Sheffield, UK. Electronic address: abdallah.al-mohammad@nhs.net. Department of Cardiology, University Hospital Southampton NHS Foundation Trust, Southampton, UK. Electronic address: Peter.Cowburn@uhs.nhs.uk. Dept Cardiology, University Hospitals Dorset NHS Foundation Trust, Bournemouth. UK. Electronic address: Chris.Critoph@uhd.nhs.uk. Dept Renal Medicine, Northern Care Alliance NHS Foundation Trust Salford Care Organisation, Salford. UK. Electronic address: philip.kalra@nca.nhs.uk. Department of Cardiology, Royal Brompton and Harefield Hospitals, London, UK. Electronic address: r.lane17@imperial.ac.uk. Department of Cardiology, Royal Devon University Healthcare NHS Foundation Trust, Exeter, UK. Electronic address: a.ludman@nhs.net. School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK. Electronic address: pierpaolo.pellicori@glasgow.ac.uk. School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK. Electronic address: mark.petrie@glasgow.ac.uk. Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK. Electronic address: Michele.Robertson@glasgow.ac.uk. Department of Cardiology, Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, UK. Electronic address: dr.seed@nhs.net. Department of Cardiovascular Sciences, University of Leicester, Leicester, UK. Electronic address: is11@leicester.ac.uk. Department of Cardiology, Portsmouth Hospitals University NHS Trust, Portsmouth, UK; College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK; Faculty of Science and Health, University of Portsmouth, Portsmouth, UK. Electronic address: paulkalra@doctors.org.uk.

Journal of cardiac failure. 2023
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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.
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Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine