[The effect of ferric citrate hydrate as an iron replacement therapy in Japanese patients with iron deficiency anemia].

Patients with iron deficiency anemia (IDA) need to take oral iron preparations, which serve as the first-line treatment in IDA, for several months in order to replenish body iron stores after the improvement of anemia. However, existing oral iron preparations have concerns regarding its long-term use due to side effects, such as gastrointestinal symptoms. Previous clinical studies have shown that ferric citrate hydrate (FC) exhibits sufficient therapeutic efficacy in patients with IDA and lowers the risks of nausea and vomiting in comparison with existing oral iron preparations. In this study, we evaluated the efficacy and safety of FC administration at doses of 500 and 1,000 mg/day for up to 24 weeks as iron replacement therapy in patients with IDA. The results of this study showed that both the doses of FC improved anemia and iron-deficiency conditions and led to sufficient iron replacement response in most patients with IDA. No safety concerns were identified. Therefore, FC is expected to be a novel oral iron preparation for patients with IDA.

Efficacy and safety of ferric citrate hydrate compared with sodium ferrous citrate in Japanese patients with iron deficiency anemia: a randomized, double-blind, phase 3 non-inferiority study.

Oral iron preparations are used as first-line treatment for iron deficiency anemia (IDA), but their gastrointestinal side effects prevent patients from appropriate adherence. We recently conducted a randomized, double-blind, phase 3 non-inferiority study to evaluate the efficacy and safety of two dosages of ferric citrate hydrate (FC) compared with sodium ferrous citrate (SF) in patients with IDA. FC at both 500 and 1000 mg/day was non-inferior to SF at 100 mg/day in terms of the change in the hemoglobin concentration at Week 7 from baseline. Logistic regression analysis suggested that the cumulative proportion of patients who achieved the target hemoglobin concentration (≥ 13.0 g/dL in male patients and ≥ 12.0 g/dL in female patients) at Week 7 was highest among those treated with FC at 1000 mg/day, followed by SF at 100 mg/day and FC at 500 mg/day. Both dosages of FC were well tolerated in patients with IDA. The incidences of nausea and vomiting were significantly lower in the FC treatment groups than in the SF group. In conclusion, FC has potential to be an oral iron preparation with sufficient efficacy for the treatment of IDA and a lower risk of nausea and vomiting.