Intravenous ferric derisomaltose for iron-deficiency anemia associated with gastrointestinal diseases: a single-arm, randomized, uncontrolled, open-label study.
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| Abstract |
Iron-deficiency anemia (IDA) associated with gastrointestinal diseases is the second most common etiology of IDA in Japan, and is most often caused by gastrointestinal bleeding. A multicenter, single-arm (2 groups), open-label, phase III study was conducted to assess the efficacy and safety of ferric derisomaltose (FDI) when administered by intravenous (IV) bolus injection (n = 30) or drip infusion (n = 10) in Japanese patients with IDA associated with gastrointestinal diseases. The primary endpoint, which was the mean maximum change in hemoglobin (Hb) concentration from baseline, was 4.33 (95% confidence interval, 3.82-4.83) g/dL in the overall population (4.27 [3.83-4.71] g/dL in the bolus injection group and 4.49 [2.69-6.29] g/dL in the drip infusion group). Treatment-emergent adverse events (TEAEs) were reported in 24 patients (60.0%) in the overall population (18 patients [60.0%] in the bolus injection group and 6 patients [60.0%] in the drip infusion group). No serious treatment-related TEAEs or unexpected safety findings were reported during the study. These findings reveal a favorable efficacy and safety profile for FDI when administered by IV bolus injection or drip infusion in Japanese patients with IDA associated with gastrointestinal diseases.
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| Authors | Hiroshi Kawabata, Takeshi Tamura, Soichiro Tamai, Tomoki Takahashi, Jun Kato, Study Group |
| Journal | International journal of hematology (Int J Hematol) Vol. 116 Issue 6 Pg. 846-855 (Dec 2022) ISSN: 1865-3774 [Electronic] Japan |
| PMID | 35867202 (Publication Type: Multicenter Study, Journal Article) |
| Copyright | © 2022. The Author(s). |
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