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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

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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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Acknowledgements

The authors are grateful to the patients and their families for their contributions. Funding was provided by Zeria Pharmaceutical Co., Ltd.

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Authors and Affiliations

  1. Division of Gastroenterology and Hematology/Oncology, Department of Medicine, Asahikawa Medical University, 2-1-1-1, Midorigaoka-Higashi, Asahikawa, Hokkaido, 078-8510, Japan

    Katsuya Ikuta

  2. New Medical Research System Clinic, Tokyo, Japan

    Hideki Hanashi

  3. Minamimorimachi Ladies’ Clinic, Osaka, Japan

    Kozo Hirai

  4. Department of Gynecology, Kurashiki Medical Center, Okayama, Japan

    Yoshiaki Ota

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

    Yutaka Matsuyama

  6. Clinical Research 2, Zeria Pharmaceutical Co., Ltd., Chuo-ku, Tokyo, Japan

    Asami Shimura & Masaru Terauchi

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

    Mikio Momoeda

Authors
  1. Katsuya Ikuta
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  2. Hideki Hanashi
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  3. Kozo Hirai
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  4. Yoshiaki Ota
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  5. Yutaka Matsuyama
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  6. Asami Shimura
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  7. Masaru Terauchi
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  8. Mikio Momoeda
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Corresponding author

Correspondence to Katsuya Ikuta.

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Conflict of interest

The present study was performed as a Phase III study funded by Zeria Pharmaceutical Co., Ltd. Hanashi, Hirai and Ota received research funding from Zeria Pharmaceutical Co., Ltd. Ikuta received personal fees as medical specialist from Zeria Pharmaceutical Co., Ltd. Momoeda received personal fees as coordinating investigator from Zeria Pharmaceutical Co., Ltd. Matsuyama received personal fees as medical statistics advisor from Statcom Company Limited. Shimura and Terauchi are employees of Zeria Pharmaceutical Co., Ltd.

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Supplemental Fig. 1

Proportion of subjects achieving increase in hemoglobin ≥2 g/dL based on the change in hemoglobin (Proportion±95% CI) (FAS). Proportion of subjects achieving a hemoglobin increase ≥2.0 g/dL at each evaluation point. Filled circle: ferric carboxymaltose, open circle: saccharated ferric oxide (JPEG 69 KB)

Supplemental Fig. 2

Proportion of subjects with a normalized hemoglobin (Proportion±95% CI) (FAS). Proportion of subjects achieving a hemoglobin≧12.0 g/dL at each evaluation point. Filled circle: ferric carboxymaltose, open circle: saccharated ferric oxide (JPEG 69 KB)

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Ikuta, K., Hanashi, H., Hirai, K. et al. 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. Int J Hematol 109, 41–49 (2019). https://doi.org/10.1007/s12185-018-2501-8

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  • DOI: https://doi.org/10.1007/s12185-018-2501-8

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