Efficacy of ferric carboxymaltose on haemoglobin response among older patients with gastrointestinal bleeding: a randomised clinical trial.
Humans
Ferric Compounds
/ adverse effects
Male
Maltose
/ analogs & derivatives
Female
Aged
Hemoglobins
/ metabolism
Gastrointestinal Hemorrhage
/ drug therapy
Aged, 80 and over
Double-Blind Method
Quality of Life
Treatment Outcome
Prospective Studies
Hematinics
/ adverse effects
France
Injections, Intravenous
Age Factors
aged
anaemia
gastrointestinal haemorrhage
iron therapy
older people
Journal
Age and ageing
ISSN: 1468-2834
Titre abrégé: Age Ageing
Pays: England
ID NLM: 0375655
Informations de publication
Date de publication:
01 May 2024
01 May 2024
Historique:
received:
18
07
2023
medline:
6
5
2024
pubmed:
6
5
2024
entrez:
6
5
2024
Statut:
ppublish
Résumé
Acute gastrointestinal bleeding (AGIB) is common in older patients but the use of iron in this context remains understudied. This study aimed to evaluate prospectively the efficacy of ferric carboxymaltose to treat anaemia in older patients after AGIB. 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. 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. 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).
Sections du résumé
BACKGROUND
BACKGROUND
Acute gastrointestinal bleeding (AGIB) is common in older patients but the use of iron in this context remains understudied.
AIMS
OBJECTIVE
This study aimed to evaluate prospectively the efficacy of ferric carboxymaltose to treat anaemia in older patients after AGIB.
METHODS
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
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
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).
Identifiants
pubmed: 38706390
pii: 7665113
doi: 10.1093/ageing/afae085
pii:
doi:
Substances chimiques
ferric carboxymaltose
6897GXD6OE
Ferric Compounds
0
Maltose
69-79-4
Hemoglobins
0
Hematinics
0
Banques de données
ClinicalTrials.gov
['NCT01690585']
Types de publication
Journal Article
Randomized Controlled Trial
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : French Ministry of Health
ID : n°13-23
Organisme : Vifor Pharma
Informations de copyright
© 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.