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Richard N, Arab-Hocine N, Vannier M, Leblanc-Boubchir R, Pelaquier A, Boruchowicz A, Musikas M, Amil M, Fumery M, Nahon S, Arotcarena R, Gelsi E, Maurin A, Hébuterne X, Savoye G. Efficacy of ferric carboxymaltose on haemoglobin response among older patients with gastrointestinal bleeding: a randomised clinical trial. Age Ageing 2024; 53:afae085. [PMID: 38706390 DOI: 10.1093/ageing/afae085] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/18/2023] [Indexed: 05/07/2024] Open
Abstract
BACKGROUND Acute gastrointestinal bleeding (AGIB) is common in older patients but the use of iron in this context remains understudied. AIMS This study aimed to evaluate prospectively the efficacy of ferric carboxymaltose to treat anaemia in older patients after AGIB. METHODS This randomised double-blinded placebo-controlled clinical trial was conducted in 10 French centres. Eligible patients were 65 years or more, had controlled upper or lower gastrointestinal bleeding and a haemoglobin level of 9-11 g/dl. Patients were randomly assigned, in a 1:1 ratio, to receive either one intravenous iron injection of ferric carboxymaltose or one injection of saline solution. The primary endpoint was the difference in haemoglobin level between day 0 and day 42. Secondary endpoints were treatment-emergent adverse events, serious adverse events, rehospitalisation and improvement of quality of life (QOL) at day 180. RESULTS From January 2013 to January 2017, 59 patients were included. The median age of patients was 81.9 [75.8, 87.3] years. At day 42, a significant difference in haemoglobin level increase was observed (2.49 g/dl in the ferric carboxymaltose group vs. 1.56 g/dl in the placebo group, P = 0.02). At day 180, QOL, measured on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, improved by 10.5 points in the ferric carboxymaltose group and by 8.2 points in the placebo group (P = 0.56). Rates of adverse events and rehospitalisation were similar in the two groups. CONCLUSIONS Intravenous iron seems safe and effective to treat anaemia in older patients after AGIB and should be considered as a standard-of-care treatment. ClinicalTrials.gov (NCT01690585).
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Affiliation(s)
- Nicolas Richard
- Department of Gastroenterology, Univ Rouen Normandie, INSERM, ADEN UMR1073, "Nutrition, Inflammation and microbiota-gut-brain axis", CHU Rouen, Rouen F-76000, France
| | - Nadia Arab-Hocine
- Department of Gastroenterology and Clinical Nutrition, CHU of Nice and University Côte d'Azur, Nice, France
| | - Margot Vannier
- Department of Biostatistics, CHU Rouen, Rouen F-76000, France
| | | | - Agnès Pelaquier
- Department of Gastroenterology, Montelimar Hospital, Montelimar, France
| | - Arnaud Boruchowicz
- Department of Gastroenterology, Valenciennes Hospital, Valenciennes, France
| | - Marietta Musikas
- Department of Gastroenterology, Caen University Hospital, Caen, France
| | - Morgane Amil
- Department of Gastroenterology, La Roche Sur Yon Hospital, La Roche Sur Yon, France
| | - Mathurin Fumery
- Department of Gastroenterology, Amiens University and Hospital, Amiens, France
| | - Stéphane Nahon
- Department of Gastroenterology, Le Raincy - Montfermeil Hospital -, Le Raincy, Montfermeil, France
| | | | - Eve Gelsi
- Department of Gastroenterology and Clinical Nutrition, CHU of Nice and University Côte d'Azur, Nice, France
| | - Arnaud Maurin
- Department of Gastroenterology, Le Mans Hospital, Le Mans, France
| | - Xavier Hébuterne
- Department of Gastroenterology and Clinical Nutrition, CHU of Nice and University Côte d'Azur, Nice, France
| | - Guillaume Savoye
- Department of Gastroenterology, Univ Rouen Normandie, INSERM, ADEN UMR1073, "Nutrition, Inflammation and microbiota-gut-brain axis", CHU Rouen, Rouen F-76000, France
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Chang A, Rugivarodom M, Pungpipattrakul N, Akarapatima K, Suwanno K, Rattanasupar A, Ovartlarnporn B, Prachayakul V. Role of oral iron supplementation for anemia secondary to acute nonvariceal upper gastrointestinal bleeding: a randomized controlled trial. J Gastroenterol Hepatol 2023; 38:1283-1291. [PMID: 36999193 DOI: 10.1111/jgh.16185] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/20/2022] [Revised: 02/27/2023] [Accepted: 03/27/2023] [Indexed: 04/01/2023]
Abstract
BACKGROUND AND AIM Although acute upper gastrointestinal bleeding (UGIB) can lead to anemia, evidence regarding the effects of oral iron supplementation on UGIB-induced anemia following discharge remains lacking. The present study aimed to investigate the effects of oral iron supplementation on hemoglobin response and iron storage in patients with anemia secondary to nonvariceal UGIB. METHODS This randomized controlled trial included 151 patients with nonvariceal UGIB who had anemia at discharge. Patients were assigned to a 1:1 block in which they were either administered 6 weeks of 600 mg/d oral ferrous fumarate (treatment group, n = 77) or treated without iron supplementation (control group, n = 74). The primary outcome was composite hemoglobin response (hemoglobin elevation greater than 2 g/dL or no anemia at the end of treatment [EOT]). RESULTS The proportion of patients achieving composite hemoglobin response was greater in the treatment group than in the control group (72.7% vs 45.9%; adjusted risk ratio [RR], 2.980; P = 0.004). At EOT, the percentage change in the hemoglobin level (34.2 ± 24.8% vs 19.4 ± 19.9%; adjusted coefficient, 11.543; P < 0.001) was significantly higher in the treatment group than in the control group; however, the proportions of patients with a serum ferritin level <30 μg/L and a transferrin saturation <16% were lower in the treatment group (all P < 0.05). No significant differences in treatment-associated adverse effects and adherence rates were observed between the groups. CONCLUSION Oral iron supplementation exerts beneficial effects on anemia and iron storage following nonvariceal UGIB without significantly impacting rates of adverse effects or adherence.
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Affiliation(s)
- Arunchai Chang
- Division of Gastroenterology, Department of Internal Medicine, Hatyai Hospital, Songkhla, Thailand
| | - Manus Rugivarodom
- Siriraj GI Endoscopy Center, Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
| | | | - Keerati Akarapatima
- Division of Gastroenterology, Department of Internal Medicine, Hatyai Hospital, Songkhla, Thailand
| | - Komsai Suwanno
- Division of Hematology, Department of Internal Medicine, Hatyai Hospital, Songkhla, Thailand
| | - Attapon Rattanasupar
- Division of Gastroenterology, Department of Internal Medicine, Hatyai Hospital, Songkhla, Thailand
| | - Bancha Ovartlarnporn
- NKC Institute of Gastroenterology and Hepatology, Faculty of Medicine, Songklanagarind Hospital, Prince of Songkla University, Songkhla, Thailand
| | - Varayu Prachayakul
- Siriraj GI Endoscopy Center, Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
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Obeidat M, Teutsch B, Rancz A, Tari E, Márta K, Veres DS, Hosszúfalusi N, Mihály E, Hegyi P, Erőss B. One in four patients with gastrointestinal bleeding develops shock or hemodynamic instability: A systematic review and meta-analysis. World J Gastroenterol 2023; 29:4466-4480. [PMID: 37576706 PMCID: PMC10415974 DOI: 10.3748/wjg.v29.i28.4466] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/10/2023] [Revised: 05/30/2023] [Accepted: 06/14/2023] [Indexed: 07/26/2023] Open
Abstract
BACKGROUND Hemodynamic instability and shock are associated with untoward outcomes in gastrointestinal bleeding. However, there are no studies in the existing literature on the proportion of patients who developed these outcomes after gastrointestinal bleeding. AIM To determine the pooled event rates in the available literature and specify them based on the bleeding source. METHODS The protocol was registered on PROSPERO in advance (CRD42021283258). A systematic search was performed in three databases (PubMed, EMBASE, and CENTRAL) on 14th October 2021. Pooled proportions with 95%CI were calculated with a random-effects model. A subgroup analysis was carried out based on the time of assessment (on admission or during hospital stay). Heterogeneity was assessed by Higgins and Thompson's I2 statistics. The Joanna Briggs Institute Prevalence Critical Appraisal Tool was used for the risk of bias assessment. The Reference Citation Analysis (https://www.referencecitationanalysis.com/) tool was applied to obtain the latest highlight articles. RESULTS We identified 11589 records, of which 220 studies were eligible for data extraction. The overall proportion of shock and hemodynamic instability in general gastrointestinal bleeding patients was 0.25 (95%CI: 0.17-0.36, I2 = 100%). In non-variceal bleeding, the proportion was 0.22 (95%CI: 0.14-0.31, I2 = 100%), whereas it was 0.25 (95%CI: 0.19-0.32, I2 = 100%) in variceal bleeding. The proportion of patients with colonic diverticular bleeding who developed shock or hemodynamic instability was 0.12 (95%CI: 0.06-0.22, I2 = 90%). The risk of bias was low, and heterogeneity was high in all analyses. CONCLUSION One in five, one in four, and one in eight patients develops shock or hemodynamic instability on admission or during hospitalization in the case of non-variceal, variceal, and colonic diverticular bleeding, respectively.
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Affiliation(s)
- Mahmoud Obeidat
- Centre for Translational Medicine, Semmelweis University, Budapest 1085, Hungary
- Institute for Translational Medicine, Medical School, University of Pécs, Pécs 7623, Hungary
| | - Brigitta Teutsch
- Centre for Translational Medicine, Semmelweis University, Budapest 1085, Hungary
- Institute for Translational Medicine, Medical School, University of Pécs, Pécs 7623, Hungary
| | - Anett Rancz
- Centre for Translational Medicine, Semmelweis University, Budapest 1085, Hungary
- Department of Internal Medicine and Hematology, Semmelweis University, Faculty of Medicine, Budapest 1085, Hungary
| | - Edina Tari
- Centre for Translational Medicine, Semmelweis University, Budapest 1085, Hungary
- Institute of Pancreatic Diseases, Semmelweis University, Budapest 1083, Hungary
| | - Katalin Márta
- Centre for Translational Medicine, Semmelweis University, Budapest 1085, Hungary
- Institute of Pancreatic Diseases, Semmelweis University, Budapest 1083, Hungary
| | - Dániel Sándor Veres
- Centre for Translational Medicine, Semmelweis University, Budapest 1085, Hungary
- Department of Biophysics and Radiation Biology, Semmelweis University, Budapest 1085, Hungary
| | - Nóra Hosszúfalusi
- Centre for Translational Medicine, Semmelweis University, Budapest 1085, Hungary
- Department of Internal Medicine and Hematology, Semmelweis University, Faculty of Medicine, Budapest 1085, Hungary
| | - Emese Mihály
- Centre for Translational Medicine, Semmelweis University, Budapest 1085, Hungary
- Department of Internal Medicine and Hematology, Semmelweis University, Faculty of Medicine, Budapest 1085, Hungary
| | - Péter Hegyi
- Centre for Translational Medicine, Semmelweis University, Budapest 1085, Hungary
- Institute for Translational Medicine, Medical School, University of Pécs, Pécs 7623, Hungary
- Institute of Pancreatic Diseases, Semmelweis University, Budapest 1083, Hungary
| | - Bálint Erőss
- Centre for Translational Medicine, Semmelweis University, Budapest 1085, Hungary
- Institute for Translational Medicine, Medical School, University of Pécs, Pécs 7623, Hungary
- Institute of Pancreatic Diseases, Semmelweis University, Budapest 1083, Hungary
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Lanas A, Andrews JM, Lau J, Toruner M, Bromley SE, Gralnek IM. Management of iron-deficiency anemia following acute gastrointestinal hemorrhage: A narrative analysis and review. J Gastroenterol Hepatol 2023; 38:23-33. [PMID: 36266733 DOI: 10.1111/jgh.16033] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/03/2022] [Revised: 08/16/2022] [Accepted: 10/13/2022] [Indexed: 01/18/2023]
Abstract
Many patients experiencing acute gastrointestinal bleeding (GIB) require iron supplementation to treat subsequent iron deficiency (ID) or iron-deficiency anemia (IDA). Guidelines regarding management of these patients are lacking. We aimed to identify areas of unmet need in patients with ID/IDA following acute GIB in terms of patient management and physician guidance. We formed an international working group of gastroenterologists to conduct a narrative review based on PubMed and EMBASE database searches (from January 2000 to February 2021), integrated with observations from our own clinical experience. Published data on this subject are limited and disparate, and those relating to post-discharge outcomes, such as persistent anemia and re-hospitalization, are particularly lacking. Often, there is no post-discharge follow-up of these patients by a gastroenterologist. Acute GIB-related ID/IDA, however, is a prevalent condition both at the time of hospital admission and at hospital discharge and is likely underdiagnosed and undertreated. Despite limited data, there appears to be notable variation in the prescribing of intravenous (IV)/oral iron regimens. There is also some evidence suggesting that, compared with oral iron, IV iron may restore iron levels faster following acute GIB, have a better tolerability profile, and be more beneficial in terms of quality of life. Gaps in patient care exist in the management of acute GIB-related ID/IDA, yet further data from large population-based studies are needed to confirm this. We advocate the formulation of evidence-based guidance on the use of iron therapies in these patients, aiding a more standardized best-practice approach to patient care.
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Affiliation(s)
- Angel Lanas
- Servicio de Aparato Digestivo, Hospital Clínico, University of Zaragoza, IIS Aragón, Zaragoza, Spain.,CIBERehd, Madrid, Spain
| | - Jane M Andrews
- Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.,Faculty of Health Science, University of Adelaide, Adelaide, South Australia, Australia
| | - James Lau
- Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China
| | - Murat Toruner
- Department of Gastroenterology, Ankara University School of Medicine, Ankara, Turkey
| | | | - Ian M Gralnek
- Institute of Gastroenterology and Hepatology, Emek Medical Center, Afula, Israel.,Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel
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ERDEM MG. Ferric Carboxymaltose Versus Ferrous Glycine Sulfate For Treatment of Iron Deficiency Anemia and Their Effect On Vitamin B12 And Folic Acid: A Retrospective Study. ARCHIVES OF CLINICAL AND EXPERIMENTAL MEDICINE 2022. [DOI: 10.25000/acem.1203980] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/28/2022] Open
Abstract
Aim Anemia is a major public health problem, affecting about one-third of the world's population, and is most commonly caused by iron deficiency. Iron deficiency anemia requires oral or intravenous iron replacement therapy. The purpose of this study was to assess the change in several hematological parameters, vitamin B12, and folic acid from baseline to the first month of follow-up following therapy with oral ferrous glycine sulfate or intravenous ferric carboxymaltose.
Methods: All patients who received oral ferrous glycine sulfate or intravenous ferric carboxymaltose for the treatment of iron deficiency anemia between January 1, 2016, and December 31, 2018, were included in the trial. Along with age and gender information, values of hemoglobin, ferritin, transferrin saturation, mean corpuscular volume, vitamin B12, and folic acid were derived from patients’ records at the beginning of treatment and first month follow-up.
Results: Laboratory values obtained after treatment showed statistically significant improvement in both groups (intra group, p<0.001). When the percentage of change between groups was compared: Percentage-based increases in hemoglobin, mean corpuscular volume, transferrin saturation and ferritin values were significantly higher in the ferric carboxymaltose group (p<0.001). The percentage decrease in vitamin B12 and folic acid values was higher in the ferric carboxymaltose group (p=0.005 and p=0.01, respectively) when compared with oral ferrous glycine sulfate group.
Conclusions: According to the findings of our study, iron deficiency anemia can be treated very successfully using ferric carboxymaltose; however, it should be remembered that concurrent supplementation of elements such vitamin B12 and folic acid is necessary for the appropriate progression of erythropoiesis.
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Montoro M, Cucala M, Lanas Á, Villanueva C, Hervás AJ, Alcedo J, Gisbert JP, Aisa ÁP, Bujanda L, Calvet X, Mearin F, Murcia Ó, Canelles P, García López S, Martín de Argila C, Planella M, Quintana M, Jericó C, García Erce JA. Indications and hemoglobin thresholds for red blood cell transfusion and iron replacement in adults with gastrointestinal bleeding: An algorithm proposed by gastroenterologists and patient blood management experts. Front Med (Lausanne) 2022; 9:903739. [PMID: 36186804 PMCID: PMC9519983 DOI: 10.3389/fmed.2022.903739] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/24/2022] [Accepted: 08/11/2022] [Indexed: 01/28/2023] Open
Abstract
Gastrointestinal (GI) bleeding is associated with considerable morbidity and mortality. Red blood cell (RBC) transfusion has long been the cornerstone of treatment for anemia due to GI bleeding. However, blood is not devoid of potential adverse effects, and it is also a precious resource, with limited supplies in blood banks. Nowadays, all patients should benefit from a patient blood management (PBM) program that aims to minimize blood loss, optimize hematopoiesis (mainly by using iron replacement therapy), maximize tolerance of anemia, and avoid unnecessary transfusions. Integration of PBM into healthcare management reduces patient mortality and morbidity and supports a restrictive RBC transfusion approach by reducing transfusion rates. The European Commission has outlined strategies to support hospitals with the implementation of PBM, but it is vital that these initiatives are translated into clinical practice. To help optimize management of anemia and iron deficiency in adults with acute or chronic GI bleeding, we developed a protocol under the auspices of the Spanish Association of Gastroenterology, in collaboration with healthcare professionals from 16 hospitals across Spain, including expert advice from different specialties involved in PBM strategies, such as internal medicine physicians, intensive care specialists, and hematologists. Recommendations include how to identify patients who have anemia (or iron deficiency) requiring oral/intravenous iron replacement therapy and/or RBC transfusion (using a restrictive approach to transfusion), and transfusing RBC units 1 unit at a time, with assessment of patients after each given unit (i.e., "don't give two without review"). The advantages and limitations of oral versus intravenous iron and guidance on the safe and effective use of intravenous iron are also described. Implementation of a PBM strategy and clinical decision-making support, including early treatment of anemia with iron supplementation in patients with GI bleeding, may improve patient outcomes and lower hospital costs.
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Affiliation(s)
- Miguel Montoro
- Unidad de Gastroenterología, Hepatología y Nutrición, Hospital Universitario San Jorge, Huesca, Spain
- Departamento de Medicina, Universidad de Zaragoza, Zaragoza, Spain
- Instituto Aragonés de Ciencias de la Salud (IACS), Zaragoza, Spain
- Instituto de Investigación Sanitaria Aragón (IIS), Zaragoza, Spain
| | | | - Ángel Lanas
- Departamento de Medicina, Universidad de Zaragoza, Zaragoza, Spain
- Instituto de Investigación Sanitaria Aragón (IIS), Zaragoza, Spain
- Servicio de Aparato Digestivo, Hospital Clínico Universitario “Lozano Blesa”, Zaragoza, Spain
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
| | - Cándido Villanueva
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
- Servei de Digestiu, Hospital de la Santa Creu y Sant Pau, Universidad Autónoma de Barcelona, Barcelona, Spain
| | - Antonio José Hervás
- Unidad de Gestión Clínica de Aparato Digestivo, Hospital Universitario Reina Sofía de Córdoba, Córdoba, Spain
| | - Javier Alcedo
- Departamento de Medicina, Universidad de Zaragoza, Zaragoza, Spain
- Servicio de Aparato Digestivo, Hospital Universitario Miguel Servet, Zaragoza, Spain
| | - Javier P. Gisbert
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
- Servicio de Aparato Digestivo, Hospital Universitario de La Princesa, Madrid, Spain
- Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid (UAM), Madrid, Spain
| | - Ángeles P. Aisa
- Servicio de Aparato Digestivo, Hospital Universitario Costa del Sol, Marbella, Spain
| | - Luis Bujanda
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
- Servicio de Aparato Digestivo, Hospital Universitario Donostia, Donostia, Spain
- Instituto de Investigación Sanitaria Biodonostia, Universidad del País Vasco (UPV/EHU), Donostia, Spain
| | - Xavier Calvet
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
- Servei de Digestiu, Corporació Sanitaria Park Taulí, Sabadell, Spain
- Department of Medicine, Universidad Autónoma de Barcelona, Barcelona, Spain
| | - Fermín Mearin
- Servicio de Aparato Digestivo, Centro Médico Teknon, Barcelona, Spain
| | - Óscar Murcia
- Servicio de Aparato Digestivo, Hospital General Universitario de Alicante, Alicante, Spain
| | - Pilar Canelles
- Servicio de Aparato Digestivo, Hospital General Universitario de Valencia, Valencia, Spain
| | - Santiago García López
- Departamento de Medicina, Universidad de Zaragoza, Zaragoza, Spain
- Servicio de Aparato Digestivo, Hospital Universitario Miguel Servet, Zaragoza, Spain
| | | | - Montserrat Planella
- Servei de Digestiu, Hospital Universitario Arnau de Vilanova, Lleida, Spain
- Department of Medicine, Universidad de Lleida, Lleida, Spain
| | - Manuel Quintana
- Servicio a Medicina Intensiva, Hospital Universitario La Paz (IdiPAZ), Madrid, Spain
- PBM Group, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain
| | - Carlos Jericó
- Servicio de Medicina Interna, Complex Hospitalari Moisès Broggi, Sant Joan Despí, Barcelona, Spain
- Grupo Español de Rehabilitación Multimodal (GERM), Zaragoza, Spain
| | - José Antonio García Erce
- PBM Group, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain
- Grupo Español de Rehabilitación Multimodal (GERM), Zaragoza, Spain
- Banco de Sangre y Tejidos de Navarra, Servicio Navarro de Salud, Osasunbidea, Pamplona, Spain
- Instituto Aragonés de Ciencias de la Salud, Universidad de Zaragoza, Zaragoza, Spain
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Cotter J, Baldaia C, Ferreira M, Macedo G, Pedroto I. Diagnosis and treatment of iron-deficiency anemia in gastrointestinal bleeding: A systematic review. World J Gastroenterol 2020; 26:7242-7257. [PMID: 33362380 PMCID: PMC7723662 DOI: 10.3748/wjg.v26.i45.7242] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/01/2020] [Revised: 07/10/2020] [Accepted: 10/26/2020] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Anemia is considered a public health issue and is often caused by iron deficiency. 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 published. AIM To review current evidence and guidelines concerning IDA management in gastrointestinal bleeding patients to develop recommendations for its diagnosis and therapy. METHODS Five gastroenterology experts formed the Digestive Bleeding and Anemia Workgroup and conducted a systematic literature search in PubMed and professional association websites. MEDLINE (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 2019. Worldwide professional association websites were searched for clinical practice guidelines. Reference lists from guidelines were reviewed to identify additional relevant articles. The recommendations were developed by consensus during two meetings and were supported by the published literature identified during the systematic search. RESULTS From 494 Literature citations found during the initial literature search, 17 original articles, one meta-analysis, and 13 clinical practice guidelines were analyzed. Based 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 hemoglobin and iron status; (2) Laboratory testing; (3) Target treatment population identification; (4) Indications for erythrocyte transfusion; (5) Treatment targets for erythrocyte transfusion; (6) Indications for intravenous iron; (7) Dosages; (8) Monitoring; (9) Indications for intravenous ferric carboxymaltose treatment; and (10) Treatment targets and monitoring of patients. The workgroup also proposed a summary algorithm for the diagnosis and treatment of IDA in patients with acute or chronic gastrointestinal bleeding, which should be implemented during the hospital stay and follow-up visits after patient discharge. CONCLUSION These recommendations may serve as a starting point for clinicians to better diagnose and treat IDA in patients with gastrointestinal bleeding, which ultimately may improve health outcomes in these patients.
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Affiliation(s)
- José Cotter
- Department of Gastroenterology, Hospital da Senhora da Oliveira-Guimarães, Guimarães 4835-044, Portugal
- Department of Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga 4710-057, Portugal
- Department of Life and Health Sciences Research Institute (ICVS)/3B’s, PT Government Associate Laboratory, Braga 4710-057, Portugal
| | - Cilénia Baldaia
- Department of Gastroenterology, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Lisbon 1649-035, Portugal
- Department of University Clinic of Medicine II, Faculty of Medicine, University of Lisbon, Lisbon 1649-028, Portugal
| | - Manuela Ferreira
- Department of Gastroenterology, Centro Hospitalar e Universitário de Coimbra, Coimbra 3000-075, Portugal
- Department of Faculty of Medicine, University of Coimbra, Coimbra 3004-504, Portugal
| | - Guilherme Macedo
- Department of Gastroenterology, Centro Hospitalar de São João, Porto 4200-319, Portugal
- Department of Gastroenterology, Faculty of Medicine, University of Porto, Porto 4200-319, Portugal
- Department of Gastroenterology and Hepatology Training Center, World Gastroenterology Organization, Porto 4200-319, Portugal
| | - Isabel Pedroto
- Department of Gastroenterology, Centro Hospitalar do Porto, Porto 4099-001, Portugal
- Department of Institute of Biomedical Sciences Abel Salazar, University of Porto, Porto 4050-313, Portugal
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8
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Ballester-Clau R, Torres Vicente G, Cucala Ramos M, Aracil Blanch C, Miñana Calafat JM, Pijoan Comas E, Reñé Espinet JM, Planella de Rubinat M. Efficacy and Safety of Treatment With Ferric Carboxymaltose in Patients With Cirrhosis and Gastrointestinal Bleeding. Front Med (Lausanne) 2020; 7:128. [PMID: 32363194 PMCID: PMC7181670 DOI: 10.3389/fmed.2020.00128] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/25/2020] [Accepted: 03/24/2020] [Indexed: 12/16/2022] Open
Abstract
Background: Patients with liver cirrhosis and gastrointestinal bleeding (GIB) often develop anemia. Ferric carboxymaltose (FCM) is an intravenous (i.v.) iron formulation approved for use in patients with iron deficiency with inadequate response to oral iron therapy or when oral iron cannot be used. Here we analyzed the efficacy and safety of FCM treatment in cirrhotic patients with anemia and GIB. Methods: Retrospective observational study of patients with cirrhosis and acute or chronic GIB treated with 1,000 mg FCM at the University Hospital Arnau de Vilanova (Lleida, Spain) that follows a restrictive-transfusion strategy. All data were obtained from the patients' medical records. We used the Wilcoxon test to evaluate statistical significance. Results: Patients with cirrhosis and GIB (n = 34) were treated with 1,000 mg FCM. Portal hypertension were present in 88.2% of the patients. For hospitalized patients (n = 21), median serum hemoglobin (s-Hb) levels increased by 3.0 g/dL (p < 0.02) and 3.9 g/dL (p < 0.07) for patients treated with FCM who had or had not received also a transfusion, respectively, compared to levels recorded upon admission. For outpatients (n = 13) the mean s-Hb levels was 9.8 ± 1.6 g/dL before FCM treatment and 11.3 ± 2.1 g/dL after treatment, demonstrating a mean increase of 1.5 g/dL (p < 0.001). No serious adverse reactions to FCM were observed. Conclusion: FCM administration achieved optimal s-Hb levels in most cirrhotic patients with acute or chronic GIB, suggesting that early FCM infusion improves and maintains optimal s-Hb levels in these patients and may be an appropriate first-line therapy to treat their anemia.
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Affiliation(s)
- Raquel Ballester-Clau
- Department of Gastroenterology, University Hospital Arnau de Vilanova, Lleida, Spain.,Biomedical Research Institute of Lleida, Lleida, Spain
| | - Gisela Torres Vicente
- Department of Gastroenterology, University Hospital Arnau de Vilanova, Lleida, Spain
| | | | - Carles Aracil Blanch
- Department of Gastroenterology, University Hospital Arnau de Vilanova, Lleida, Spain.,Biomedical Research Institute of Lleida, Lleida, Spain
| | - Josep Maria Miñana Calafat
- Department of Gastroenterology, University Hospital Arnau de Vilanova, Lleida, Spain.,Biomedical Research Institute of Lleida, Lleida, Spain
| | - Eva Pijoan Comas
- Department of Gastroenterology, University Hospital Arnau de Vilanova, Lleida, Spain
| | - Josep Maria Reñé Espinet
- Department of Gastroenterology, University Hospital Arnau de Vilanova, Lleida, Spain.,Biomedical Research Institute of Lleida, Lleida, Spain
| | - Montse Planella de Rubinat
- Department of Gastroenterology, University Hospital Arnau de Vilanova, Lleida, Spain.,Biomedical Research Institute of Lleida, Lleida, Spain
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Ferrer‐Barceló L, Sanchis Artero L, Sempere García‐Argüelles J, Canelles Gamir P, P. Gisbert J, Ferrer‐Arranz LM, Monzó Gallego A, Plana Campos L, Huguet Malavés JM, Luján Sanchis M, Ruiz Sánchez L, Barceló Cerdá S, Medina Chuliá E. Randomised clinical trial: intravenous vs oral iron for the treatment of anaemia after acute gastrointestinal bleeding. Aliment Pharmacol Ther 2019; 50:258-268. [PMID: 31197861 PMCID: PMC6771644 DOI: 10.1111/apt.15327] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/09/2019] [Revised: 01/15/2019] [Accepted: 05/08/2019] [Indexed: 12/13/2022]
Abstract
BACKGROUND Acute gastrointestinal bleeding is prevalent condition and iron deficiency anaemia is a common comorbidity, yet anaemia treatment guidelines for affected patients are lacking. AIM To compare efficacy and safety of intravenous ferric carboxymaltose (FCM) and oral ferrous sulphate (FeSulf) in patients with anaemia secondary to non-variceal gastrointestinal bleeding METHODS: A prospective 42-day study randomised 61 patients with haemoglobin <10 g/dL upon discharge (Day 0) to receive FCM (n = 29; Day 0: 1000 mg, Day 7: 500 or 1000 mg; per label) or FeSulf (n = 32; 325 mg/12 hours for 6 weeks). Outcome measures were assessed on Days 0 (baseline), 7, 21 and 42. The primary outcome was complete response (haemoglobin ≥12 g/dL [women], ≥13 g/dL [men]) after 6 weeks. RESULTS A higher proportion of complete response was observed in the FCM vs the FeSulf group at Days 21 (85.7% vs 45.2%; P = 0.001) and 42 (100% vs 61.3%; P < 0.001). Additionally, the percentage of patients with partial response (haemoglobin increment ≥2 g/dL from baseline) was significantly higher in the FCM vs the FeSulf group (Day 21:100% vs 67.7%; P = 0.001, Day 42:100% vs 74.2%; P = 0.003). At Day 42, normalisation of transferrin saturation to 25% or greater was observed in 76.9% of FCM vs 24.1% of FeSulf-treated patients (P < 0.001). No patient in the FCM group reported any adverse event vs 10 patients in the FeSulf group. CONCLUSION FCM provided greater and faster Hb increase and iron repletion, and was better tolerated than FeSulf in patients with iron deficiency anaemia secondary to non-variceal acute gastrointestinal bleeding.
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Affiliation(s)
- Luis Ferrer‐Barceló
- Hospital General Universitario de ValenciaServicio de Patología DigestivaValenciaSpain
| | - Laura Sanchis Artero
- Hospital General Universitario de ValenciaServicio de Patología DigestivaValenciaSpain
| | | | - Pilar Canelles Gamir
- Hospital General Universitario de ValenciaServicio de Patología DigestivaValenciaSpain
| | - Javier P. Gisbert
- Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS‐IP) y Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd)MadridSpain
| | | | - Ana Monzó Gallego
- Hospital General Universitario de ValenciaServicio de Patología DigestivaValenciaSpain
| | - Lydia Plana Campos
- Hospital General Universitario de ValenciaServicio de Patología DigestivaValenciaSpain
| | | | - Marisol Luján Sanchis
- Hospital General Universitario de ValenciaServicio de Patología DigestivaValenciaSpain
| | - Lucía Ruiz Sánchez
- Hospital General Universitario de ValenciaServicio de Patología DigestivaValenciaSpain
| | - Susana Barceló Cerdá
- Departamento de Estadística e Investigación Operativa y CalidadUniversitat Politècnica de ValènciaValenciaSpain
| | - Enrique Medina Chuliá
- Hospital General Universitario de ValenciaServicio de Patología DigestivaValenciaSpain
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