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Age Ageing ; 53(5)2024 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-38706390

RESUMO

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).


Assuntos
Compostos Férricos , Hemorragia Gastrointestinal , Hemoglobinas , Maltose , Maltose/análogos & derivados , Qualidade de Vida , Humanos , Compostos Férricos/efeitos adversos , Compostos Férricos/administração & dosagem , Compostos Férricos/uso terapêutico , Masculino , Maltose/administração & dosagem , Maltose/efeitos adversos , Maltose/uso terapêutico , Feminino , Idoso , Hemoglobinas/metabolismo , Hemoglobinas/análise , Hemorragia Gastrointestinal/tratamento farmacológico , Idoso de 80 Anos ou mais , Método Duplo-Cego , Resultado do Tratamento , Estudos Prospectivos , Hematínicos/efeitos adversos , Hematínicos/administração & dosagem , Hematínicos/uso terapêutico , França , Injeções Intravenosas , Fatores Etários
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