Ferumoxytol and Abnormal Bleeding (FAB): Intravenous Iron Versus Oral Iron to Correct Anemia in Patients With Abnormal Uterine Bleeding [ID 1095]

INTRODUCTION: Abnormal uterine bleeding (AUB) is associated with anemia. Correction of anemia is often needed prior to treatment of gynecologic conditions. We performed a randomized control trial comparing use of oral iron to ferumoxytol intravenous (IV) iron to rapidly correct anemia in patients with AUB. METHODS: Patients aged 18–55 with AUB and anemia were enrolled. Participants were randomized to 60 days of oral ferrous sulfate, 325 mg, or two infusions of ferumoxytol, 510 mg. Hemoglobin levels, quality of life scores, and bleeding diaries were assessed at 14, 30, and 60 days after treatment. The primary outcome was the change in hemoglobin at 60-day follow-up. Planned sample size was 68 participants, with planned mid-point data analysis specifying stopping criteria for highly significant results. RESULTS: Forty-seven participants enrolled, with 34 completing all study visits at time of interim analysis. Per criteria, the study was stopped after interim analysis. Baseline hemoglobin was similar (9.8 g/dL versus 9.1 g/dL, P =.09). Sixty-day hemoglobin and change from baseline were significantly higher in the IV iron compared to oral iron group (10.3 g/dL versus 12.1 g/dL, P <.001; 0.52 g/dL versus 3.0 g/dL, P <.001), even as bleeding patterns were similar in the groups. Quality of life and side effects were similar, although the oral iron group had more constipation (63% versus 6%, P <.001). CONCLUSIONS/IMPLICATIONS: Two-dose ferumoxytol IV iron corrects anemia better than oral ferrous sulfate in patients with AUB. For rapid correction of anemia, providers should consider IV rather than oral iron.