Efficacy of ferric carboxymaltose on haemoglobin response among older patients with gastrointestinal bleeding: a randomised clinical trial.

Autor:	Richard N; Department of Gastroenterology, Univ Rouen Normandie, INSERM, ADEN UMR1073, 'Nutrition, Inflammation and microbiota-gut-brain axis', CHU Rouen, Rouen F-76000, France., Arab-Hocine N; Department of Gastroenterology and Clinical Nutrition, CHU of Nice and University Côte d'Azur, Nice, France., Vannier M; Department of Biostatistics, CHU Rouen, Rouen F-76000, France., Leblanc-Boubchir R; Department of Gastroenterology, Valenciennes Hospital, Valenciennes, France., Pelaquier A; Department of Gastroenterology, Montelimar Hospital, Montelimar, France., Boruchowicz A; Department of Gastroenterology, Valenciennes Hospital, Valenciennes, France., Musikas M; Department of Gastroenterology, Caen University Hospital, Caen, France., Amil M; Department of Gastroenterology, La Roche Sur Yon Hospital, La Roche Sur Yon, France., Fumery M; Department of Gastroenterology, Amiens University and Hospital, Amiens, France., Nahon S; Department of Gastroenterology, Le Raincy - Montfermeil Hospital -, Le Raincy, Montfermeil, France., Arotcarena R; Department of Gastroenterology, Pau Hospital, Pau, France., Gelsi E; Department of Gastroenterology and Clinical Nutrition, CHU of Nice and University Côte d'Azur, Nice, France., Maurin A; Department of Gastroenterology, Le Mans Hospital, Le Mans, France., Hébuterne X; Department of Gastroenterology and Clinical Nutrition, CHU of Nice and University Côte d'Azur, Nice, France., Savoye G; Department of Gastroenterology, Univ Rouen Normandie, INSERM, ADEN UMR1073, 'Nutrition, Inflammation and microbiota-gut-brain axis', CHU Rouen, Rouen F-76000, France.
Jazyk:	angličtina
Zdroj:	Age and ageing [Age Ageing] 2024 May 01; Vol. 53 (5).
DOI:	10.1093/ageing/afae085
Abstrakt:	Background: Acute gastrointestinal bleeding (AGIB) is common in older patients but the use of iron in this context remains understudied. Aims: This study aimed to evaluate prospectively the efficacy of ferric carboxymaltose to treat anaemia in older patients after AGIB. Methods: This randomised double-blinded placebo-controlled clinical trial was conducted in 10 French centres. Eligible patients were 65 years or more, had controlled upper or lower gastrointestinal bleeding and a haemoglobin level of 9-11 g/dl. Patients were randomly assigned, in a 1:1 ratio, to receive either one intravenous iron injection of ferric carboxymaltose or one injection of saline solution. The primary endpoint was the difference in haemoglobin level between day 0 and day 42. Secondary endpoints were treatment-emergent adverse events, serious adverse events, rehospitalisation and improvement of quality of life (QOL) at day 180. Results: From January 2013 to January 2017, 59 patients were included. The median age of patients was 81.9 [75.8, 87.3] years. At day 42, a significant difference in haemoglobin level increase was observed (2.49 g/dl in the ferric carboxymaltose group vs. 1.56 g/dl in the placebo group, P = 0.02). At day 180, QOL, measured on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, improved by 10.5 points in the ferric carboxymaltose group and by 8.2 points in the placebo group (P = 0.56). Rates of adverse events and rehospitalisation were similar in the two groups. Conclusions: Intravenous iron seems safe and effective to treat anaemia in older patients after AGIB and should be considered as a standard-of-care treatment. ClinicalTrials.gov (NCT01690585). (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
Databáze:	MEDLINE
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