Efficacy and safety of intravenous sodium ferric gluconate complex in iron-deficient patients hospitalized for heart failure: a meta-analysis
N B Tran, V Q T Ho, N Nguyen, V N D NguyenAbstract
Background
Iron deficiency is common among patients hospitalized for heart failure and is associated with worse clinical outcomes. Although intravenous ferric carboxymaltose has demonstrated clinical benefit, evidence supporting the use of sodium ferric gluconate complex (SFGC) remains limited despite its lower cost and widespread availability.
Purpose
To evaluate the efficacy and safety of intravenous SFGC compared with no iron therapy in patients hospitalized for heart failure with iron deficiency, on top of standard therapy.
Methods
We conducted a systematic review and meta-analysis of randomized and observational studies including adult patients hospitalized for heart failure with iron deficiency. Studies comparing intravenous sodium ferric gluconate with no iron administration or placebo were eligible. Searches were performed in PubMed, Embase, and Cochrane. Primary outcomes were hospital re-admission due to heart failure at 30 days, 3 months, 6 months and at the end of follow-up. Secondary outcomes were any adverse events, and treatment-limiting or serious adverse events. Pooled risk ratios (RR) with 95% confidence intervals were calculated using random-effects models.
Results
Out of 9 database results, three studies consisting of 997 patients were included, including two retrospective cohort studies and one randomized controlled trial. The mean age was 71.34 in the sodium ferric gluconate group and 74.2 in the no iron group. Males accounted for 59.52% in the therapy group and 51.08% of patients in the no iron group. Compared to no iron therapy, Sodium ferric gluconate complex showed comparable risk of heart failure readmission at 30 days (RR=1.11; 95% CI: 0.61, 2.01; p=0.73), at 3 months (RR=1.39; 95% CI: 0.88, 2.18; p=0.15), at 6 months (RR=1.01; 95% CI: 0.58, 1.74; p=0.98) and at the end of follow-up (RR=1.09; 95% CI: 0.83, 1.44; p=0.52). There was no significant difference in the risk of adverse events between groups (RR = 8.37, 95% CI 0.47, 148.05; p=0.15), and no treatment-limiting or serious adverse events were observed, supporting the safety of sodium ferric gluconate.
Conclusion
In patients hospitalized for heart failure with iron deficiency, sodium ferric gluconate was not associated with reduced readmissions but showed a favorable safety profile. Given its low cost and wide availability, it may represent a practical alternative when other intravenous iron formulations are not accessible, although further randomized trials are needed to confirm clinical benefit.Forest plots_Heart failure readmissionFor image description, please refer to the figure legend and surrounding text.Forest plot_Adverse eventsFor image description, please refer to the figure legend and surrounding text.