{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T04:55:14Z","timestamp":1784782514682,"version":"3.55.0"},"reference-count":18,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2022,7,22]],"date-time":"2022-07-22T00:00:00Z","timestamp":1658448000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,7,22]],"date-time":"2022-07-22T00:00:00Z","timestamp":1658448000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100018036","name":"Nippon Shinyaku","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100018036","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Hematol"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>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 (<jats:italic>n<\/jats:italic>\u2009=\u200930) or drip infusion (<jats:italic>n<\/jats:italic>\u2009=\u200910) 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\u20134.83) g\/dL in the overall population (4.27 [3.83\u20134.71] g\/dL in the bolus injection group and 4.49 [2.69\u20136.29] 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.<\/jats:p>","DOI":"10.1007\/s12185-022-03420-x","type":"journal-article","created":{"date-parts":[[2022,7,22]],"date-time":"2022-07-22T14:04:07Z","timestamp":1658498647000},"page":"846-855","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Intravenous ferric derisomaltose for iron-deficiency anemia associated with gastrointestinal diseases: a single-arm, randomized, uncontrolled, open-label study"],"prefix":"10.1007","volume":"116","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1918-8635","authenticated-orcid":false,"given":"Hiroshi","family":"Kawabata","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeshi","family":"Tamura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Soichiro","family":"Tamai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoki","family":"Takahashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Kato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ito","family":"Hiroaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanaka","family":"Hironori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hosokawa","family":"Takanori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kitsukawa","family":"Yoshio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ogata","family":"Shinichi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshida","family":"Rihito","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iwase","family":"Shigeru","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kido","family":"Osamu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akiho","family":"Hirotada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kusumoto","family":"Hirotake","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matsuda","family":"Tomoki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takahashi","family":"Shuji","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matsuyama","family":"Kiichi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hamahata","family":"Yukihiro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abe","family":"Hisanori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,7,22]]},"reference":[{"key":"3420_CR1","doi-asserted-by":"publisher","first-page":"260","DOI":"10.3324\/haematol.2019.232124","volume":"105","author":"C Camaschella","year":"2020","unstructured":"Camaschella C, Nai A, Silvestri L. Iron metabolism and iron disorders revisited in the hepcidin era. Haematologica. 2020;105:260\u201372.","journal-title":"Haematologica"},{"key":"3420_CR2","first-page":"10","volume-title":"Guidelines for the treatment of anemia by proper use of iron preparations","author":"T Uchida","year":"2009","unstructured":"Uchida T. Guidelines for the treatment of iron deficiency anemia. In: Society TJB, editor. Guidelines for the treatment of anemia by proper use of iron preparations. 2nd ed. Sapporo, Japan: Kyobun-sha; 2009. p. 10\u20137.","edition":"2"},{"key":"3420_CR3","volume-title":"Guidelines for the treatment of anemia by proper use of iron preparations","author":"The Japanese BioIron Society","year":"2015","unstructured":"The Japanese BioIron Society. Guidelines for the treatment of anemia by proper use of iron preparations. 3rd ed. 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Dr. H. Kawabata reports honoraria for lectures and consulting fees associated with his role in the submitted study as a medical officer from Nippon Shinyaku Co., Ltd. He is also a board member of the Japanese BioIron Society. Dr. J. Kato reports consulting fees associated with his role in the submitted study as a coordinating investigator from Nippon Shinyaku Co., Ltd. T. Tamura, S. Tamai, and T. Takahashi are employees of Nippon Shinyaku Co., Ltd.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}