KEY TAKEAWAYS
- The FerHem phase 3 trial aimed to investigate the efficacy and safety of iron supplementation in older patients with AGIB to address the gap in understanding its utility in this population.
- The primary endpoint was to determine the difference in hemoglobin levels.
- Researchers noticed that intravenous iron emerges as a safe and effective SOC treatment for anemia in older patients with AGIB.
Acute gastrointestinal bleeding (AGIB) is common in older patients, but the use of iron in this context remains understudied.
Nicolas Richard and the team aimed to investigate the efficacy and safety of iron supplementation in older patients with AGIB to address the gap in understanding its utility in this population.
They performed an inclusive analysis, conducting a randomized, double-blinded, placebo-controlled clinical trial across 10 centers. Eligible participants, aged 65 or older, with controlled upper or lower gastrointestinal bleeding and a hemoglobin level of 9-11 g/dl, were randomly assigned, in a 1:1 ratio, to receive either intravenous ferric carboxymaltose or saline solution.
The primary endpoint assessed the difference in hemoglobin levels between day 0 and day 42. Secondary endpoints included treatment-emergent adverse events, serious adverse events, rehospitalization, and improvement in quality of life (QOL) at day 180.
About 59 patients were included from January 2013 to January 2017. The median age of patients was 81.9 [75.8, 87.3] years. On day 42, a significant increase in hemoglobin level 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 the 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 8.2 points in the placebo group (P = 0.56). Rates of adverse events and rehospitalization were similar in the 2 groups.
The study concluded that intravenous iron emerges as a safe and effective standard-of-care treatment for anemia in older patients following AGIB, suggesting its consideration in clinical practice.
The trial was sponsored by the University Hospital, Rouen.
Source: https://pubmed.ncbi.nlm.nih.gov/38706390/
Clinical Trial: https://clinicaltrials.gov/study/NCT01690585
Richard N, Arab-Hocine N, Vannier M, et al. (2024). “Efficacy of ferric carboxymaltose on haemoglobin response among older patients with gastrointestinal bleeding: a randomised clinical trial.” Age Ageing. 2024 May 1;53(5):afae085. doi: 10.1093/ageing/afae085. PMID: 38706390.
