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A randomized,controlled,open label non-inferiority trial of intravenous ferric carboxymaltose versus iron sucrose in patients with iron deficiency anemia in China

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Frontiers of Medicine 2024年第1期18卷 98-108页

作者： Jie Jin Zhihua Ran Emanuele Noseda Bernard Roubert Matthieu Marty Anna Mezzacasa Udo Michael Göring The First Affiliated Hospital Zhejiang University College of MedicineHangzhou310058China Renji Hospital Shanghai Jiao Tong University School of MedicineShanghai200025China Vifor Pharma Glattbrugg8152Switzerland

Iron deficiency(ID)and ID anemia(IDA)pose significant public health concerns in *** iron sucrose(IS)treatment is well-established in the country,ferric carboxymaltose(FCM)offers the advantage of higher doses and fewer *** open label,randomized,controlled,non-inferiority trial was conducted at multiple sites in China to compare the outcomes of FCM(maximum of 2 doses,500 or 1000 mg iron)and IS(up to 11 infusions,200 mg iron)treatments in subjects with *** primary endpoint was the achievement of hemoglobin(Hb)response(an increase of⩾2 g/dL from baseline)within 8 weeks,whereas secondary endpoints included changes in Hb,transferrin saturation,and serum ferritin *** the 371 randomized subjects,a similar percentage of subjects treated with FCM and IS achieved Hb-response(FCM 99.4%,IS 98.3%),thereby confirming the non-inferiority of FCM compared with IS(difference 1.12(−2.15,4.71;95%confidence interval(CI))).Furthermore,a significantly higher proportion of FCM-treated subjects achieved early Hb-response at Week 2(FCM 85.2%,IS 73.2%;difference 12.1(3.31,20.65;95%CI)).Additionally,the increase in TSAT and serum ferritin levels from baseline was significantly greater at all time points for FCM-treated *** safety profiles of FCM and IS were comparable,with the exception of transient hypophosphatemia and pyrexia,which are consistent with FCM’s known safety *** conclusion,FCM proves to be an efficacious treatment for IDA,providing faster Hb-response and correction of ID with fewer administrations than IS.

关键词： iron deficiency anemia intravenous iron ferric carboxymaltose iron sucrose Hb response early response

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ferric carboxymaltose for anemia in Crohn’s disease patients at a tertiary center:A retrospective observational cohort study

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World Journal of Clinical Cases 2023年第12期11卷 2740-2752页

作者： Natália Souza Nunes Siqueira Livia Bitencourt Pascoal Bruno Lima Rodrigues Marina Moreira de Castro Alan Sidnei Corrêa Martins Dante Orsetti Silva Araújo Luis Eduardo Miani Gomes Michel Gardere Camargo Maria de Lourdes Setsuko Ayrizono Raquel Franco Leal Inflammatory Bowel Disease Research Laboratory GastrocenterColorectal Surgery UnitSchool of Medical SciencesUniversity of Campinas(Unicamp)Campinas 13083-878São PauloBrazil

BACKGROUND Although the gastrointestinal tract is the most affected by Crohn’s disease(CD),the condition triggers other consequent manifestations,and iron deficiency anemia(IDA)is one of the most ***(IV)iron replacement is currently available through several drugs,such as ferric hydroxide sucrose and ferric carboxymaltose(FCM).However,the clinical management of these conditions can be *** To elucidate the drug’s effectiveness,the present study analyzed,through medical records,the clinical and epidemiological data of a cohort of patients with active CD who received IV FCM for the IDA *** This retrospective observational study included 25 patients with active CD,severe anemia,and refractory to previous conventional *** were evaluated two times:During the last treatment with ferric hydroxide sucrose and treatment with *** After treatment with FCM,parameters of IDA assessment significantly improved,serum hemoglobin(Hb)levels increased in 93%of patients(Pferric hydroxide sucrose treatment remained similar to those found before *** This study demonstrated that FCM is an important therapeutic strategy for treating IDA in CD patients,achieving satisfactory results in refractory cases.

关键词： ferric carboxymaltose Iron deficiency anemia Crohn’s disease Inflammatory bowel disease Anemia Clinical management

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Diagnosis and treatment of iron-deficiency anemia in gastrointestinal bleeding:A systematic review

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World Journal of Gastroenterology 2020年第45期26卷 7242-7257页

作者： Jose Cotter Cilenia Baldaia Manuela Ferreira Guilherme Macedo Isabel Pedroto Department of Gastroenterology Hospital da Senhora da Oliveira-GuimarãesGuimarães 4835-044Portugal Department of Life and Health Sciences Research Institute(ICVS) School of MedicineUniversity of MinhoBraga 4710-057Portugal Department of Life and Health Sciences Research Institute(ICVS)/3B’s PT Government Associate LaboratoryBraga 4710-057Portugal Department of Gastroenterology Hospital de Santa MariaCentro Hospitalar Lisboa NorteLisbon 1649-035Portugal Department of University Clinic of Medicine II Faculty of MedicineUniversity of LisbonLisbon 1649-028Portugal Department of Gastroenterology Centro Hospitalar e Universitário de CoimbraCoimbra 3000-075Portugal Department of Faculty of Medicine University of CoimbraCoimbra 3004-504Portugal Department of Gastroenterology Centro Hospitalar de São JoãoPorto 4200-319Portugal Department of Gastroenterology Faculty of MedicineUniversity of PortoPorto 4200-319Portugal Department of Gastroenterology and Hepatology Training Center World Gastroenterology OrganizationPorto 4200-319Portugal Department of Gastroenterology Centro Hospitalar do PortoPorto 4099-001Portugal Department of Institute of Biomedical Sciences Abel Salazar University of PortoPorto 4050-313Portugal

BACKGROUND Anemia is considered a public health issue and is often caused by iron ***-deficiency anemia(IDA)often originates from blood loss from lesions in the gastrointestinal tract in men and postmenopausal women,and its prevalence among patients with gastrointestinal bleeding has been estimated to be 61%.However,few guidelines regarding the appropriate investigation of patients with IDA due to gastrointestinal bleeding have been *** To review current evidence and guidelines concerning IDA management in gastrointestinal bleeding patients to develop recommendations for its diagnosis and *** Five gastroenterology experts formed the Digestive Bleeding and Anemia Workgroup and conducted a systematic literature search in PubMed and professional association ***(via PubMed)searches combined medical subject headings(MeSH)terms and the keywords“gastrointestinal bleeding”with“iron-deficiency anemia”and“diagnosis”or“treatment”or“management”or“prognosis”or“prevalence”or“safety”or“iron”or“transfusion”or“quality of life”,or other terms to identify relevant articles reporting the management of IDA in patients over the age of 18 years with gastrointestinal bleeding;retrieved studies were published in English between January 2003 and April *** professional association websites were searched for clinical practice *** lists from guidelines were reviewed to identify additional relevant *** recommendations were developed by consensus during two meetings and were supported by the published literature identified during the systematic *** From 494 Literature citations found during the initial literature search,17 original articles,one meta-analysis,and 13 clinical practice guidelines were *** on the published evidence and clinical experience,the workgroup developed the following ten recommendations for the management of IDA in patients with gastrointestinal bleeding:(1)Evaluation of

关键词： Anemia iron-deficiency Erythrocyte transfusion ferric carboxymaltose Gastrointestinal hemorrhage Iron Practice guidelines as topic

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patients with inflammatory bowel disease:Mechanisms and possible clinical impact

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World Journal of Gastroenterology 2021年第17期27卷 2039-2053页

作者： Trond Espen Detlie Jonas Christoffer Lindstrøm Marte Eide Jahnsen Elisabeth Finnes Heinz Zoller Bjørn Moum Jørgen Jahnsen Department of Gastroenterology Akershus University HospitalLørenskog 1478Norway Institute of Clinical Medicine University of OsloOslo 0316Norway Health Services Research Unit Akershus University HospitalLørenskog 1478Norway Division of Medicine Department of GastroenterologyOslo University Hospital UllevålOslo 0424Norway Department of Medicine II Gastroenterology and HepatologyMedical University of InnsbruckInnsbruck A-6020Austria

BACKGROUND High-dose intravenous iron is an effective treatment option for iron deficiency(ID)or ID anaemia(IDA)in inflammatory bowel disease(IBD).However,treatment with ferric carboxymaltose(FCM)has been associated with the development of *** To investigate mechanisms behind the development of hypophosphatemia after intravenous iron treatment,and disclose symptoms and clinical manifestations related to hypophosphatemia *** A prospective observational study of adult IBD patients with ID or IDA was conducted between February 1,2017 and July 1,2018 at two separate university hospitals in the southeast region of *** received one dose of 1000 mg of either FCM or ferric derisomaltose(FDI)and were followed for an observation period of at least 7 *** and urine samples were collected for relevant analyses at baseline,week 2 and at week *** symptoms were assessed at the same timepoints using a respiratory function test,a visual analogue scale,and a health-related quality of life *** A total of 106 patients was available for analysis in this *** FCM treatment group consisted of 52 patients and hypophosphatemia was present in 72.5%of the patients at week 2,and in 21.6%at week *** comparison,the FDI treatment group consisted of 54 patients and 11.3%of the patients had hypophosphatemia at week 2,and 3.7%at week *** difference in incidence was highly significant at both week 2 and 6(P<0.001 and P<0.013,respectively).We observed a significantly higher mean concentration of intact fibroblast growth factor 23(P<0.001),a significant rise in mean urine fractional excretion of phosphate(P=0.004),a significant decrease of 1,25-dihydroxyvitamin D(P<0.001)and of ionised calcium levels(P<0.012)in the FCM-treated patients compared with patients who received *** clinical symptoms could with certainty be related to hypophosphatemia,since neither the respiratory function test,SF-36(36-item short form health s

关键词： Iron deficiency Hypophosphatemia Inflammatory bowel disease ferric carboxymaltose ferric derisomaltose

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