{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T15:41:31Z","timestamp":1787499691315,"version":"build-2736575974"},"reference-count":16,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2013,6,17]],"date-time":"2013-06-17T00:00:00Z","timestamp":1371427200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2014,2]]},"abstract":"\n Background<\/jats:title>\n \n Many patients receiving oral iron for iron deficiency anemia (\n IDA<\/jats:styled-content>\n ) cannot tolerate or fail to respond to therapy, and existing intravenous (\n IV<\/jats:styled-content>\n ) iron formulations often require repeated administrations. Ferric carboxymaltose (\n FCM<\/jats:styled-content>\n ), a nondextran\n IV<\/jats:styled-content>\n formulation, permits larger single doses.\n <\/jats:p>\n <\/jats:sec>\n \n Study Design and Methods<\/jats:title>\n \n We evaluated\n FCM<\/jats:styled-content>\n versus oral iron in\n IDA<\/jats:styled-content>\n patients. After 14 days of oral iron, 507 participants responding inadequately to oral iron (hemoglobin [Hb] increase <1\u2009g\/\n dL<\/jats:styled-content>\n ; Cohort\u20091) were assigned to Group\u2009A (two doses of\n FCM<\/jats:styled-content>\n , 750\u2009mg, 1 week apart) or Group\u2009B (oral iron, 325\u2009mg, 3\u2009\u00d7\u2009day for 14 additional days). Also, 504 subjects not appropriate for oral iron (Cohort\u20092) were assigned to Group\u2009C (\n FCM<\/jats:styled-content>\n as above) or Group\u2009D (standard\u2010of\u2010care\n IV<\/jats:styled-content>\n iron). The primary efficacy endpoint was change to highest observed Hb from baseline to Day 35. The composite safety endpoint included all\u2010cause mortality, nonfatal myocardial infarction, nonfatal stroke, unstable angina, heart failure, arrhythmias, and hyper\u2010 or hypotensive events.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Mean (\u00b1 standard deviation [\n SD<\/jats:styled-content>\n ]) Hb increase was significantly greater in Group\u2009A\u2013\n FCM<\/jats:styled-content>\n than Group\u2009B\u2013oral iron: 1.57 (\u00b11.19) g\/\n dL<\/jats:styled-content>\n versus 0.80 (\u00b10.80) g\/\n dL<\/jats:styled-content>\n (p\u2009=\u20090.001). Post hoc comparison of Group\n C<\/jats:styled-content>\n \u2013\n FCM<\/jats:styled-content>\n and Group\u2009\n D<\/jats:styled-content>\n \u2013IV standard of care also demonstrated significant mean (\u00b1\n SD<\/jats:styled-content>\n ) increase in Hb from baseline to highest value by Day 35 in Group\u2009C versus Group\u2009D: 2.90 (\u00b11.64) g\/\n dL<\/jats:styled-content>\n versus 2.16 (\u00b11.25) g\/dL (p\u2009=\u20090.001). Safety endpoints occurred in 17 of 499 (3.4%) participants receiving\n FCM<\/jats:styled-content>\n versus 16 of 498 (3.2%) in comparator groups.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n \n Two 750\u2010mg\n FCM<\/jats:styled-content>\n infusions are safe and superior to oral iron in increasing Hb levels in\n IDA<\/jats:styled-content>\n patients with inadequate oral iron response.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/trf.12289","type":"journal-article","created":{"date-parts":[[2013,6,18]],"date-time":"2013-06-18T00:37:49Z","timestamp":1371515869000},"page":"306-315","source":"Crossref","is-referenced-by-count":130,"title":["A multicenter, randomized, active\u2010controlled study to investigate the efficacy and safety of intravenous ferric carboxymaltose in patients with iron deficiency anemia"],"prefix":"10.1111","volume":"54","author":[{"given":"Jane E.","family":"Onken","sequence":"first","affiliation":[{"name":"Duke Clinical Research Institute Durham North Carolina"},{"name":"Luitpold Pharmaceuticals, Inc. Norristown Pennsylvania"},{"name":"Albert Einstein College of Medicine New York New York"},{"name":"Stanford University School of Medicine Stanford California"},{"name":"Webb Writes, LLC Durham North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David B.","family":"Bregman","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute Durham North Carolina"},{"name":"Luitpold Pharmaceuticals, Inc. Norristown Pennsylvania"},{"name":"Albert Einstein College of Medicine New York New York"},{"name":"Stanford University School of Medicine Stanford California"},{"name":"Webb Writes, LLC Durham North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert A.","family":"Harrington","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute Durham North Carolina"},{"name":"Luitpold Pharmaceuticals, Inc. Norristown Pennsylvania"},{"name":"Albert Einstein College of Medicine New York New York"},{"name":"Stanford University School of Medicine Stanford California"},{"name":"Webb Writes, LLC Durham North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Morris","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute Durham North Carolina"},{"name":"Luitpold Pharmaceuticals, Inc. Norristown Pennsylvania"},{"name":"Albert Einstein College of Medicine New York New York"},{"name":"Stanford University School of Medicine Stanford California"},{"name":"Webb Writes, LLC Durham North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Acs","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute Durham North Carolina"},{"name":"Luitpold Pharmaceuticals, Inc. Norristown Pennsylvania"},{"name":"Albert Einstein College of Medicine New York New York"},{"name":"Stanford University School of Medicine Stanford California"},{"name":"Webb Writes, LLC Durham North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce","family":"Akright","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute Durham North Carolina"},{"name":"Luitpold Pharmaceuticals, Inc. Norristown Pennsylvania"},{"name":"Albert Einstein College of Medicine New York New York"},{"name":"Stanford University School of Medicine Stanford California"},{"name":"Webb Writes, LLC Durham North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Barish","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute Durham North Carolina"},{"name":"Luitpold Pharmaceuticals, Inc. Norristown Pennsylvania"},{"name":"Albert Einstein College of Medicine New York New York"},{"name":"Stanford University School of Medicine Stanford California"},{"name":"Webb Writes, LLC Durham North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Birbal S.","family":"Bhaskar","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute Durham North Carolina"},{"name":"Luitpold Pharmaceuticals, Inc. Norristown Pennsylvania"},{"name":"Albert Einstein College of Medicine New York New York"},{"name":"Stanford University School of Medicine Stanford California"},{"name":"Webb Writes, LLC Durham North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gioi N.","family":"Smith\u2010Nguyen","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute Durham North Carolina"},{"name":"Luitpold Pharmaceuticals, Inc. Norristown Pennsylvania"},{"name":"Albert Einstein College of Medicine New York New York"},{"name":"Stanford University School of Medicine Stanford California"},{"name":"Webb Writes, LLC Durham North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angelia","family":"Butcher","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute Durham North Carolina"},{"name":"Luitpold Pharmaceuticals, Inc. Norristown Pennsylvania"},{"name":"Albert Einstein College of Medicine New York New York"},{"name":"Stanford University School of Medicine Stanford California"},{"name":"Webb Writes, LLC Durham North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Todd A.","family":"Koch","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute Durham North Carolina"},{"name":"Luitpold Pharmaceuticals, Inc. Norristown Pennsylvania"},{"name":"Albert Einstein College of Medicine New York New York"},{"name":"Stanford University School of Medicine Stanford California"},{"name":"Webb Writes, LLC Durham North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence T.","family":"Goodnough","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute Durham North Carolina"},{"name":"Luitpold Pharmaceuticals, Inc. Norristown Pennsylvania"},{"name":"Albert Einstein College of Medicine New York New York"},{"name":"Stanford University School of Medicine Stanford California"},{"name":"Webb Writes, LLC Durham North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2013,6,17]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1373\/49.10.1573"},{"key":"e_1_2_8_3_1","volume-title":"Iron therapy with special emphasis on intravenous administration","author":"Crichton RR","year":"2005"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1177\/0884533608314536"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2011-01-258467"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.21656"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-200969060-00007"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijgo.2007.10.009"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2008.07.046"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.AOG.0000275286.03283.18"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2009.02327.x"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0908355"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2011.06.005"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/gfq613"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.97.18.1837"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/jbmr.1923"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.23354"}],"container-title":["Transfusion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Ftrf.12289","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.12289","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,1]],"date-time":"2023-10-01T12:33:30Z","timestamp":1696163610000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/trf.12289"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013,6,17]]},"references-count":16,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2014,2]]}},"alternative-id":["10.1111\/trf.12289"],"URL":"https:\/\/doi.org\/10.1111\/trf.12289","archive":["Portico"],"relation":{"has-review":[{"id-type":"doi","id":"10.3410\/f.718026367.793481541","asserted-by":"object"}]},"ISSN":["0041-1132","1537-2995"],"issn-type":[{"value":"0041-1132","type":"print"},{"value":"1537-2995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2013,6,17]]}}}