International Journal of Hematology

DOI: 10.1007/s12185-018-2501-8 Pages: 1-9

Comparison of efficacy and safety between intravenous ferric carboxymaltose and saccharated ferric oxide in Japanese patients with iron-deficiency anemia due to hypermenorrhea: a multi-center, randomized, open-label noninferiority study

1. Asahikawa Medical University, Division of Gastroenterology and Hematology/Oncology, Department of Medicine

2. New Medical Research System Clinic

3. Minamimorimachi Ladies’ Clinic

4. Kurashiki Medical Center, Department of Gynecology

5. The University of Tokyo, Department of Biostatistics, School of Public Health, Graduate School of Medicine

6. Zeria Pharmaceutical Co., Ltd., Clinical Research 2

7. St. Luke’s International Hospital, Department of Integrated Women’s Health

Correspondence to:
Katsuya Ikuta
Tel: +81-166-68-2462
Email: ikuta@asahikawa-med.ac.jp

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Abstract

The intravenous formulation for supplementing iron currently available in Japan requires frequent administration. In contrast, ferric carboxymaltose (FCM) can improve iron-deficiency anemia (IDA) with only a small number of administrations; however, its efficacy and safety have not been established in Japanese patients. In this randomized, open-label study, we verified the noninferiority of FCM to saccharated ferric oxide (SFO) in Japanese patients with IDA due to hypermenorrhea, with the mean change from baseline to the highest observed hemoglobin level as the primary endpoint. Two hundred and thirty-eight eligible subjects (119 in FCM group, 119 in SFO group) were administered the investigational medicinal product and included in the analysis. The adjusted mean change from baseline to the highest observed hemoglobin level (95% CI) was 3.90 g/dL (3.77, 4.04) in the FCM group and 4.05 g/dL (3.92, 4.19) in the SFO group, and the difference between the groups (95% CI) was − 0.15 g/dL (− 0.35, 0.04). The noninferiority of FCM was verified. Incidence of adverse events was < 60% in both groups, and no significant difference was observed between the treatment groups. These results indicate that FCM can be a new, well-tolerated, and rapid treatment option for Japanese patients with IDA.

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