1
|
Broekaert IJ, Assa A, Borrelli O, Saccomani MD, Homan M, Martin‐de‐Carpi J, Mas E, Miele E, Misak Z, Sila S, Thomson M, Tzivinikos C, Dolinsek J. Approach to anaemia in gastrointestinal disease: A position paper by the ESPGHAN Gastroenterology Committee. J Pediatr Gastroenterol Nutr 2025; 80:510-532. [PMID: 39783775 PMCID: PMC11874238 DOI: 10.1002/jpn3.12454] [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: 02/12/2024] [Revised: 10/31/2024] [Accepted: 12/10/2024] [Indexed: 01/12/2025]
Abstract
Anaemia is a frequent consequence of many gastrointestinal (GI) diseases in children and it can even be the initial presenting symptom of underlying chronic GI disease. The definition of anaemia is age and gender-dependent and it can be classified based on pathophysiology, red cell morphology, and clinical presentation. Although nutritional deficiencies, including GI malabsorption of nutrients and GI bleeding, play a major role, other pathophysiologic mechanisms seen in chronic GI diseases, whether inflammatory (e.g., inflammatory bowel disease) or not (e.g., coeliac disease and dysmotility), are causing anaemia. Drugs, such as proton pump inhibitors, mesalamine, methotrexate and sulfasalazine, are also a potential cause of anaemia. Not uncommonly, due to a combination of factors, such as iron deficiency and a chronic inflammatory state, the underlying pathophysiology may be difficult to decipher and a broad diagnostic work-up is required. The goal of treatment is correction of anaemia by supplementation of iron and vitamins. The first therapeutic step is to treat the underlying cause of anaemia including bleeding control, restoration of intestinal integrity and reduction of inflammatory burden. The route of iron and vitamin supplementation is guided by the severity of anaemia.
Collapse
Affiliation(s)
- Ilse Julia Broekaert
- Department of Paediatrics, Faculty of Medicine and University Hospital CologneUniversity of CologneCologneGermany
| | - Amit Assa
- The Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition, Shaare Zedek Medical CentreThe Hebrew UniversityJerusalemIsrael
| | - Osvaldo Borrelli
- Division of Neurogastroenterology & Motility, Department of Paediatric GastroenterologyGreat Ormond Street HospitalLondonUK
| | | | - Matjaž Homan
- Department of Gastroenterology, Hepatology and Nutrition, University Children's HospitalFaculty of MedicineUniversity of LjubljanaLjubljanaSlovenia
| | - Javier Martin‐de‐Carpi
- Department of Paediatric Gastroenterology, Hepatology and NutritionHospital Sant Joan de DéuBarcelonaSpain
| | - Emmanuel Mas
- Service de Gastroentérologie, Hépatologie, Nutrition et Maladies Héréditaires du Métabolisme, Hôpital des Enfants, and IRSDUniversité de Toulouse, INSERM, INRAE, ENVT, UPSToulouseFrance
| | - Erasmo Miele
- Department of Translational Medical Science, Section of PediatricsUniversity of Naples “Federico II”NaplesItaly
| | - Zrinjka Misak
- Referral Centre for Paediatric Gastroenterology and NutritionChildren's Hospital ZagrebZagrebCroatia
| | - Sara Sila
- Referral Centre for Paediatric Gastroenterology and NutritionChildren's Hospital ZagrebZagrebCroatia
| | - Mike Thomson
- Centre for Paediatric GastroenterologySheffield Children's Hospital NHS Foundation TrustSheffieldUK
| | - Christos Tzivinikos
- Paediatric Gastroenterology Department, Al Jalila Children's Specialty HospitalMohammed Bin Rashid University, Dubai Medical CollegeDubaiUnited Arab Emirates
| | - Jernej Dolinsek
- Department of PaediatricsUniversity Medical Centre MariborMariborSlovenia
| |
Collapse
|
2
|
Dutta AK, Chinthala H, George JT, Thomas DM, Joseph Joseph A. Anemia in inflammatory bowel disease-A comprehensive review. Indian J Gastroenterol 2025:10.1007/s12664-024-01735-7. [PMID: 39954228 DOI: 10.1007/s12664-024-01735-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/04/2024] [Accepted: 12/21/2024] [Indexed: 02/17/2025]
Abstract
Anemia is a frequent complication in inflammatory bowel disease (IBD) patients. The etiology is multifactorial, with iron deficiency and anemia of chronic disease being the main reasons. Other causes include vitamin B12 and folate deficiency, hemolytic anemia and medications such as azathioprine and sulfasalazine. Apart from physical symptoms, it is associated with several negative outcomes, including poor quality of life, increased risk of hospital admission, increased risk of surgery and higher treatment costs. Diagnostic evaluation aims to identify the underlying cause and severity to determine the appropriate therapeutic strategy. Investigations include a complete blood count, iron indices, inflammatory markers and vitamin B12 and folate levels. Patients with iron deficiency need adequate replacement therapy to improve hemoglobin and replenish iron stores. Those with moderate to severe anemia and/or active disease need intravenous iron, while mild anemia can be treated with oral iron. Multiple parenteral iron formulations are available which differ in dose and frequency of administration. Traditional oral iron supplements are available in ferrous forms, which, although effective, are associated with gastrointestinal side effects. Newer oral iron formulations have helped reduce these adverse effects but are expensive. Anemia of chronic disease is mainly driven by the effects of inflammatory mediators on iron metabolism and erythropoiesis and treatment requires control of disease activity. Relapse of anemia after therapy is frequent; hence, patients need to be closely followed up for early detection and appropriate management. Significant advances have been made in understanding the pathophysiology of anemia in IBD and better and safer iron formulations are available. However, a significant proportion of IBD patients with anemia go undetected or untreated and there is a need for improved recognition and better management practices. This review discusses various aspects of anemia in IBD and the current approach to diagnosis and management.
Collapse
Affiliation(s)
- Amit Kumar Dutta
- Department of Gastroenterology, Christian Medical College Vellore, Ranipet Campus, Vellore, 632 517, India.
| | - Hemanth Chinthala
- Department of Gastroenterology, Christian Medical College Vellore, Ranipet Campus, Vellore, 632 517, India
| | - John Titus George
- Department of Gastroenterology, Christian Medical College Vellore, Ranipet Campus, Vellore, 632 517, India
| | - David Mathew Thomas
- Department of Gastroenterology, Christian Medical College Vellore, Ranipet Campus, Vellore, 632 517, India
| | - Anjilivelil Joseph Joseph
- Department of Gastroenterology, Christian Medical College Vellore, Ranipet Campus, Vellore, 632 517, India
| |
Collapse
|
3
|
Strubbe M, David K, Peene B, Eeckhout B, Van der Schueren B, Decallonne B, Vangoitsenhoven R, Vanderschueren D, Antonio L. No longer to be ignored: Hypophosphatemia following intravenous iron administration. Rev Endocr Metab Disord 2025; 26:125-135. [PMID: 39648248 DOI: 10.1007/s11154-024-09926-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 11/01/2024] [Indexed: 12/10/2024]
Abstract
Intravenous iron supplementation is increasingly used to safely and effectively correct iron deficiency anemia, but some formulations are linked to a renal phosphate wasting syndrome which is mediated by fibroblast growth factor 23. Unawareness among prescribers and the nonspecific clinical symptoms of hypophosphatemia result in underreporting of this complication. Even though it is often an asymptomatic and self-limiting condition, accumulating evidence from case reports and dedicated randomized controlled trials show that IV iron induced hypophosphatemia may be associated with clinical symptoms. If hypophosphatemia is not recognized and treated, a metabolic bone disease phenotype may develop, pathophysiologically reminiscent of hypophosphatemic rickets as seen in X-linked hypophosphatemic rickets or oncogenic osteomalacia. This syndrome is particularly, but not uniquely, associated with formulations containing ferric carboxymaltose, probably due to specific chemical characteristics of its carbohydrate moiety. Risk factors include repeated infusion, severity of iron deficiency, as well as normal kidney function. Coexisting vitamin D deficiency or hyperparathyroidism increase the risk of metabolic bone disease. Complications can be easily prevented by an early diagnosis and switching to another IV iron formulation. In this review, we describe the epidemiology and pathophysiology of this condition, to raise awareness among prescribing clinicians.
Collapse
Affiliation(s)
- Matthijs Strubbe
- Department of Endocrinology, University Hospitals Leuven, Leuven, Belgium
| | - Karel David
- Department of Endocrinology, University Hospitals Leuven, Leuven, Belgium
| | - Bernard Peene
- Department of Endocrinology, Ziekenhuis Geel, Geel, Belgium
| | - Bert Eeckhout
- Department of Endocrinology, Ziekenhuis Geel, Geel, Belgium
| | - Bart Van der Schueren
- Department of Endocrinology, University Hospitals Leuven, Leuven, Belgium
- Clinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium
| | - Brigitte Decallonne
- Department of Endocrinology, University Hospitals Leuven, Leuven, Belgium
- Clinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium
| | - Roman Vangoitsenhoven
- Department of Endocrinology, University Hospitals Leuven, Leuven, Belgium
- Clinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium
| | - Dirk Vanderschueren
- Department of Endocrinology, University Hospitals Leuven, Leuven, Belgium
- Clinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium
| | - Leen Antonio
- Department of Endocrinology, University Hospitals Leuven, Leuven, Belgium.
- Clinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.
| |
Collapse
|
4
|
Malireddi A, Abera M, Suresh SB, Ansar M, Boddeti S, Noor K, Khan S. Safety and Efficacy of Ferric Carboxymaltose for Iron Deficiency Anemia in Inflammatory Bowel Disease: A Systematic Review. Cureus 2024; 16:e76065. [PMID: 39835061 PMCID: PMC11743820 DOI: 10.7759/cureus.76065] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/24/2024] [Accepted: 12/19/2024] [Indexed: 01/22/2025] Open
Abstract
Ulcerative colitis and Crohn's disease, two types of inflammatory bowel disease (IBD), often cause anemia, primarily due to iron deficiency and chronic inflammation. Anemia negatively affects patients' daily functioning and quality of life, causing symptoms including headaches, exhaustion, and dyspnea. In IBD, iron deficiency arises from reduced intake, chronic blood loss, and impaired absorption. While oral iron supplements are commonly used, their poor absorption and gastrointestinal side effects limit their effectiveness, especially in IBD patients. The European Crohn's and Colitis Organization (ECCO) recommends intravenous iron, such as ferric carboxymaltose (FCM), as iron deficiency anemia in IBD can be managed using a safe and efficient substitute. With regard to treating iron deficiency anemia in patients with IBD, the purpose of this study is to investigate the safety and effectiveness of intravenous ferric carboxymaltose. We conducted a thorough search of medical databases, such as the Cochrane library, PubMed, and ResearchGate, to gather relevant literature. Using the databases, we found a total of 297 relevant articles. The identified studies have been screened, eligibility criteria have been introduced, and 14 research studies were selected for inclusion. This review adhered to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines, with quality assessments conducted using the Cochrane risk of bias 2 scale for randomized tests and the Newcastle-Ottawa scale for observational examination. We reviewed 14 research articles involving 2,493 patients. Among these, five were randomized controlled trials (RCTs), and the remaining nine were observational studies. The primary outcomes assessed were the therapeutic response (defined as hemoglobin ≥2 g/dL rise or normalization, improvement in iron profile parameters) and any adverse effects after FCM is administered to IBD patients. FCM was found to be highly effective in improving hemoglobin and iron profile parameters, with a generally good safety profile. Ferric carboxymaltose was the most efficient and well-tolerated intravenous (IV) iron formulation, proving safer and more effective than other iron therapies in patients suffering from IBD. However, severe hypophosphatemia can lead to serious complications, including heart failure, pulmonary failure, rhabdomyolysis, fractures, and osteomalacia, which may worsen its long-term impact. Therefore, the risk of hypophosphatemia associated with prolonged FCM use requires careful monitoring and further research to ensure its long-term safety and assess its effects on patients' quality of life.
Collapse
Affiliation(s)
| | - Mahlet Abera
- Internal Medicine, Saint Paul Millennium Medical College, Addis Ababa, ETH
| | - Suchith B Suresh
- Internal Medicine, Montefiore St. Luke's Cornwall, Newburgh, USA
| | - Mehwish Ansar
- General Surgery, Wirral University Teaching Hospital, Wirral, GBR
- General Surgery, California Institute of Behavioral Neurosciences and Psychology, Fairfield, USA
| | - Sruthi Boddeti
- Obstetrics and Gynecology, Tirumala Jyothi Hospital, Visakhapatnam, USA
| | - Khutaija Noor
- Foundation of Clinical Research, Harvard Medical School, Boston, USA
- Neuropsychiatry, PsychCare Consultant Research, Saint Louis, USA
- Internal Medicine, Shadan Institute of Medical Sciences, Peeramcheru, IND
| | - Safeera Khan
- Internal Medicine, California Institute of Behavioral Neurosciences and Psychology, Fairfield, USA
| |
Collapse
|
5
|
Chaturvedi J, K R, Bahadur A, Heda A, Mundhra R. Comparative analysis of ferric carboxymaltose and iron sucrose in treating iron deficiency anemia in perimenopausal women with heavy menstrual bleeding: a randomized controlled trial. Obstet Gynecol Sci 2024; 67:565-573. [PMID: 39492639 PMCID: PMC11581812 DOI: 10.5468/ogs.24065] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/03/2024] [Revised: 09/10/2024] [Accepted: 10/08/2024] [Indexed: 11/05/2024] Open
Abstract
OBJECTIVE To evaluate the impact of intravenous ferric carboxymaltose (FCM) compared to iron sucrose (ISC) in perimenopausal women with heavy menstrual bleeding (HMB) and anemia. METHODS This prospective, open-label, randomized controlled trial enrolled perimenopausal women (40-50 years) with HMB and hemoglobin levels between 6-10 g/dL, intolerant or non-compliant to oral iron therapy. The study compared FCM and ISC by assessing hematological parameters, including hemoglobin, ferritin, and iron levels, over a 12-week period. The patients were followed up at 3, 6, and 12 weeks after initiation. The adverse effects were also evaluated. RESULTS The study included 60 perimenopausal women, with 30 in each group. The baseline patient characteristics were comparable. FCM demonstrated a statistically significant higher mean increase in hemoglobin (4.97 g/dL) than ISC (4.63 g/dL) over 12 weeks. The proportion of patients achieving correction of anemia (hemoglobin ≥12 g/dL) was higher in the FCM group (75.9% vs. 65.5%). Serum ferritin levels were significantly higher in the FCM group after 3 weeks. Adverse effects were minimal and comparable between the groups. Although the direct cost of FCM is high, its ability to be administered in larger doses may result in lower total costs. CONCLUSION In perimenopausal women with heavy menstrual bleeding and iron deficiency anemia, FCM and ISC show comparable efficacy in increasing hemoglobin levels with similar side effect profiles. This study highlights the potential benefits of FCM and calls for further exploration of these therapies in diverse patient populations.
Collapse
Affiliation(s)
- Jaya Chaturvedi
- Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Rishikesh, India
| | - Rupendra K
- Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Rishikesh, India
| | - Anupama Bahadur
- Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Rishikesh, India
| | - Ayush Heda
- Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Rishikesh, India
| | - Rajlaxmi Mundhra
- Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Rishikesh, India
| |
Collapse
|
6
|
Tabish M, Agarwal S, Gopi S, Rana R, Ahmed S, Gunjan D, Sharma S, Saraya A. Randomized Controlled Trial of Intravenous Ferric Carboxymaltose vs Oral Iron to Treat Iron Deficiency Anemia After Variceal Bleed in Patients With Cirrhosis. Am J Gastroenterol 2024; 119:2061-2069. [PMID: 38517084 DOI: 10.14309/ajg.0000000000002775] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/11/2024] [Accepted: 03/13/2024] [Indexed: 03/23/2024]
Abstract
INTRODUCTION Limited evidence exists on the optimal strategy to correct iron deficiency anemia after variceal bleeding (VB) in cirrhosis. This trial compared the efficacy and safety of intravenous ferric carboxymaltose (IV-FCM) with those of oral iron therapy in this cohort. METHODS In this open-label, single-center, randomized controlled trial, eligible patients with hemoglobin <10 g/dL and iron deficiency (ferritin <100 ng/mL) after VB received either IV-FCM (1,500-2,000 mg) divided into 2 doses (n = 48) or oral carbonyl iron (100 mg elemental iron/day) (n = 44) for 3 months. The primary outcome was change in hemoglobin at 3 months. Secondary outcomes included improvement in anemia (last hemoglobin >12 g/dL), normalization of iron stores (ferritin >100 ng/mL), liver-related adverse events, adverse drug reactions, and changes in quality of life (CLDQOL questionnaire). RESULTS Baseline characteristics, including median Child-Turcotte-Pugh score 7 (interquartile range [IQR] 6-9), Model for End-Stage Liver Disease score 12 (IQR 10-17), blood hemoglobin (8.25 ± 1.06 g/dL), and ferritin (30.00 ng/mL [15.00-66.50]), were comparable in both arms. The median increase in hemoglobin at 3 months in the IV and oral arms was 3.65 g/dL (IQR 2.55-5.25) and 1.10 g/dL (IQR 0.05-2.90 g/dL) ( P < 0.001), respectively. Iron stores normalized in 84.6% and 21% of the IV and oral arms, respectively ( P < 0.001). Anemia improved in 50% and 21.9% in the IV and oral arms, respectively ( P < 0.009). Patients in the IV arm showed a significant improvement in all domains of CLDQOL. Liver-related adverse events were comparable in both arms. Transient mild/moderate hypophosphatemia developed in 43% of patients receiving IV-FCM. DISCUSSION Intravenous iron replacement is efficacious and safe to treat iron deficiency anemia after VB in patients with cirrhosis.
Collapse
Affiliation(s)
- Mohammad Tabish
- Department of Gastroenterology and Human Nutrition Unit, All India Institute of Medical Sciences, New Delhi, India
| | | | | | | | | | | | | | | |
Collapse
|
7
|
Stratmann K, Hentschel V, Zeuzem S, Blumenstein I, Klaus J. [Iron supplementation in patients with chronic inflammatory bowel disease: recommendations for a practical approach]. ZEITSCHRIFT FUR GASTROENTEROLOGIE 2024; 62:1389-1396. [PMID: 38657618 DOI: 10.1055/a-2274-1610] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 04/26/2024]
Abstract
Iron deficiency is the predominant cause of anemia. Iron deficiency anemia plays a major role, especially in patients with inflammatory bowel disease (IBD), and is the most common extraintestinal manifestation and IBD-associated systemic complication. The presence of anemia leads to a reduction in quality of life in patients with IBD associated with limitations in physical, emotional, and cognitive function. In addition, it is associated with an increased hospitalization rate. For this reason, iron supplementation is of particular importance. Oral and intravenous iron supplements are used to treat iron deficiency. Due to the lack of absorption and gastrointestinal side effects of oral substitution, intravenous supplementation is becoming increasingly important. However, there are still certain concerns about intravenous administration.With the help of this review, we want to address the topic of iron substitution in patients with IBD, summarize current guideline recommendations, and provide a practical approach.
Collapse
Affiliation(s)
- Katharina Stratmann
- Universitätsklinikum, Medizinische Klinik 1, Goethe-Universität Frankfurt, Frankfurt am Main, Germany
| | | | - Stefan Zeuzem
- Universitätsklinikum, Medizinische Klinik 1, Goethe-Universität Frankfurt, Frankfurt am Main, Germany
| | - Irina Blumenstein
- Universitätsklinikum, Medizinische Klinik 1, Goethe-Universität Frankfurt, Frankfurt am Main, Germany
| | - Jochen Klaus
- Klinik für Innere Medizin 1, Universitätsklinikum Ulm, Ulm, Germany
| |
Collapse
|
8
|
Sturm A, Atreya R, Bettenworth D, Bokemeyer B, Dignass A, Ehehalt R, Germer CT, Grunert PC, Helwig U, Horisberger K, Herrlinger K, Kienle P, Kucharzik T, Langhorst J, Maaser C, Ockenga J, Ott C, Siegmund B, Zeißig S, Stallmach A. Aktualisierte S3-Leitlinie „Diagnostik und Therapie des Morbus Crohn“ der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) (Version 4.1) – living guideline. ZEITSCHRIFT FUR GASTROENTEROLOGIE 2024; 62:1229-1318. [PMID: 39111333 DOI: 10.1055/a-2309-6123] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/02/2024]
Affiliation(s)
- Andreas Sturm
- Klinik für Innere Medizin mit Schwerpunkt Gastroenterologie, DRK Kliniken Berlin Westend, Berlin, Deutschland
| | - Raja Atreya
- Medizinische Klinik 1, Universitätsklinikum Erlangen, Erlangen, Deutschland
| | | | - Bernd Bokemeyer
- Gastroenterologische Gemeinschaftspraxis Minden, Minden, Deutschland
| | - Axel Dignass
- Medizinische Klinik I, Agaplesion Markus Krankenhaus, Frankfurt am Main, Deutschland
| | | | | | - P C Grunert
- Klinik für Innere Medizin IV (Gastroenterologie, Hepatologie und Infektiologie), Universitätsklinikum Jena, Deutschland
| | - Ulf Helwig
- Internistische Praxengemeinschaft, Oldenburg, Deutschland
| | - Karoline Horisberger
- Universitätsmedizin Johannes Gutenberg, Universität Klinik f. Allgemein-,Visceral- und Transplantationschirurgie, Mainz, Deutschland
| | | | - Peter Kienle
- Allgemein- und Viszeralchirurgie, Theresienkrankenhaus und Sankt Hedwig-Klinik GmbH, Mannheim, Deutschland
| | - Torsten Kucharzik
- Klinik für Allgemeine Innere Medizin und Gastroenterologie, Klinikum Lüneburg, Lüneburg, Deutschland
| | - Jost Langhorst
- Klinik für Integrative Medizin und Naturheilkunde, Klinikum am Bruderwald, Bamberg, Deutschland
| | - Christian Maaser
- Gastroenterologie, Ambulanzzentrum Lüneburg, Lüneburg, Deutschland
| | - Johann Ockenga
- Medizinische Klinik II, Klinikum Bremen Mitte - Gesundheit Nord, Bremen, Deutschland
| | - Claudia Ott
- Gastroenterologie Facharztzentrum, Regensburg, Deutschland
| | - Britta Siegmund
- Medizinische Klinik I, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Deutschland
| | - Sebastian Zeißig
- Medizinische Klinik und Poliklinik I, Universitätsklinikum Dresden, Deutschland
| | - Andreas Stallmach
- Klinik für Innere Medizin IV (Gastroenterologie, Hepatologie und Infektiologie), Universitätsklinikum Jena, Deutschland
| |
Collapse
|
9
|
Martinelli M, Fioretti MT, Aloi M, Alvisi P, Arrigo S, Banzato C, Bramuzzo M, Campanozzi A, Civitelli F, Knafelz D, Lionetti P, Marseglia A, Musto F, Norsa L, Palumbo G, Renzo S, Romano C, Sansotta N, Strisciuglio C, Miele E. Diagnosis and management of anemia in pediatric inflammatory bowel diseases: Clinical practice guidelines on behalf of the SIGENP IBD Working group. Dig Liver Dis 2024; 56:1257-1269. [PMID: 38503658 DOI: 10.1016/j.dld.2024.02.016] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/02/2023] [Revised: 02/22/2024] [Accepted: 02/22/2024] [Indexed: 03/21/2024]
Abstract
Anemia is one of the most frequent extra-intestinal manifestations of inflammatory bowel disease. Insidious onset, variability of symptoms and lack of standardized screening practices may increase the risk of underestimating its burden in children with IBD. Despite its relevance and peculiarity in everyday clinical practice, this topic is only dealt with in a few documents specifically for the pediatric field. The aim of the current guidelines is therefore to provide pediatric gastroenterologists with a practical update to support the clinical and therapeutic management of children with IBD and anemia. A panel of 19 pediatric gastroenterologists and 1 pediatric hematologist with experience in the field of pediatric IBD was agreed by IBD Working group of the Italian Society of Gastroenterology, Hepatology and Nutrition (SIGENP) to produce the present article outlining practical clinical approaches to the pediatric patient with IBD and anemia. The levels of evidence and recommendations have been defined for each part of the statement according to the GRADE system.
Collapse
Affiliation(s)
- Massimo Martinelli
- Department of Translational Medical Science, Section of Pediatrics, University of Naples "Federico II"
| | - Maria Teresa Fioretti
- Department of Translational Medical Science, Section of Pediatrics, University of Naples "Federico II"
| | - Marina Aloi
- Women's and Children's Health Department, Pediatric Gastroenterology and Hepatology Unit, Sapienza University of Rome, Rome, Italy
| | - Patrizia Alvisi
- Pediatric Gastroenterology Unit, Maggiore Hospital, Bologna, Italy
| | - Serena Arrigo
- Pediatric Gastroenterology and Endoscopy Unit, IRCCS Giannina Gaslini, Genova, Italy
| | - Claudia Banzato
- Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, Pediatric Division, University of Verona, Verona, Italy
| | - Matteo Bramuzzo
- Institute for Maternal and Child Health, IRCCS "Burlo Garofolo", Trieste, Italy
| | - Angelo Campanozzi
- Department of Medical and Surgical Sciences, Section of Pediatrics, University of Foggia, Italy
| | - Fortunata Civitelli
- Department of Gender diseases, Child and Adolescent health, Pediatric unit, Sant' Eugenio Hospital, Rome, Italy
| | - Daniela Knafelz
- Hepatology and Gastroenterology Unit, Bambino Gesù Hospital, Rome, Italy
| | - Paolo Lionetti
- University of Florence-Gastroenterology and Nutrition Unit, Meyer Children's Hospital, IRCCS, Florence
| | - Antonio Marseglia
- Fondazione IRCCS Casa Sollievo della Sofferenza, Division of Pediatrics, San Giovanni Rotondo, Italy
| | - Francesca Musto
- Women's and Children's Health Department, Pediatric Gastroenterology and Hepatology Unit, Sapienza University of Rome, Rome, Italy
| | - Lorenzo Norsa
- Pediatric Department Vittore Buzzi Children's Hospital, University of Milan, Italy
| | - Giuseppe Palumbo
- Department of Haematology, Bambino Gesù Hospital, 00165 Rome, Italy
| | - Sara Renzo
- University of Florence-Gastroenterology and Nutrition Unit, Meyer Children's Hospital, IRCCS, Florence
| | - Claudio Romano
- Pediatric Gastroenterology and Cystic Fibrosis Unit, University of Messina, Messina, Italy
| | - Naire Sansotta
- Paediatric Hepatology Gastroenterology and Transplantation, Papa Giovanni XXIII Hospital, Bergamo, Italy
| | - Caterina Strisciuglio
- Department of Woman, Child and General and Specialistic Surgery, University of Campania "Luigi Vanvitelli", Naples, Italy
| | - Erasmo Miele
- Department of Translational Medical Science, Section of Pediatrics, University of Naples "Federico II".
| |
Collapse
|
10
|
Kucharzik T, Dignass A, Atreya R, Bokemeyer B, Esters P, Herrlinger K, Kannengiesser K, Kienle P, Langhorst J, Lügering A, Schreiber S, Stallmach A, Stein J, Sturm A, Teich N, Siegmund B. Aktualisierte S3-Leitlinie Colitis ulcerosa (Version 6.2). ZEITSCHRIFT FUR GASTROENTEROLOGIE 2024; 62:769-858. [PMID: 38718808 DOI: 10.1055/a-2271-0994] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 07/02/2024]
Affiliation(s)
- T Kucharzik
- Klinik für Allgemeine Innere Medizin und Gastroenterologie, Städtisches Klinikum Lüneburg, Lüneburg, Deutschland
| | - A Dignass
- Medizinische Klinik I, Agaplesion Markus Krankenhaus, Frankfurt, Deutschland
| | - R Atreya
- Medizinische Klinik 1 Gastroent., Pneumologie, Endokrin., Universitätsklinikum Erlangen, Erlangen, Deutschland
| | - B Bokemeyer
- Interdisziplinäres Crohn Colitis Centrum Minden - ICCCM, Minden, Deutschland
| | - P Esters
- Medizinische Klinik I, Agaplesion Markus Krankenhaus, Frankfurt, Deutschland
| | - K Herrlinger
- Innere Medizin I, Asklepios Klinik Nord, Hamburg, Deutschland
| | - K Kannengiesser
- Klinik für Allgemeine Innere Medizin und Gastroenterologie, Städtisches Klinikum Lüneburg, Lüneburg, Deutschland
| | - P Kienle
- Abteilung für Allgemein- und Viszeralchirurgie, Theresienkrankenhaus, Mannheim, Deutschland
| | - J Langhorst
- Klinik für Integrative Medizin und Naturheilkunde, Sozialstiftung Bamberg Klinikum am Bruderwald, Bamberg, Deutschland
| | - A Lügering
- Medizinisches Versorgungszentrum Portal 10, Münster, Deutschland
| | - S Schreiber
- Klinik für Innere Medizin I, Universitätsklinikum Schleswig Holstein, Kiel, Deutschland
| | - A Stallmach
- Klinik für Innere Medizin IV Gastroenterologie, Hepatologie, Infektiologie, Universitätsklinikum Jena, Jena, Deutschland
| | - J Stein
- Abteilung Innere Medizin mit Schwerpunkt Gastroenterologie, Krankenhaus Sachsenhausen, Frankfurt, Deutschland
| | - A Sturm
- Klinik für Innere Medizin mit Schwerpunkt Gastroenterologie, DRK Kliniken Berlin Westend, Berlin, Deutschland
| | - N Teich
- Internistische Gemeinschaftspraxis, Leipzig, Deutschland
| | - B Siegmund
- Medizinische Klinik für Gastroenterologie, Infektiologie und Rheumatologie, Charité Campus Benjamin Franklin - Universitätsmedizin Berlin, Berlin, Deutschland
| |
Collapse
|
11
|
Kaur T, Upadhyay J, Nandave M, Alsayari A, Alshehri SA, Pukale S, Wahab S, Ahmad W, Rashid S, Ansari MN. Exploring progress in iron supplement formulation approaches for treating iron deficiency anemia through bibliometric and thematic analysis. Heliyon 2024; 10:e29058. [PMID: 38623202 PMCID: PMC11016621 DOI: 10.1016/j.heliyon.2024.e29058] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/24/2023] [Revised: 03/04/2024] [Accepted: 03/28/2024] [Indexed: 04/17/2024] Open
Abstract
Anemia is a severe health issue that affects around one-third of the global population. Therefore, the present study aims to conduct a bibliometric analysis to investigate the research trends regarding advancements on iron formulations in treating iron deficiency anemia via oral or parenteral route. This study adopts thematic and bibliometric methods on existing research on novel iron formulations. It also provides perspective into the existing understanding on treatment strategies for iron deficiency anemia. This study is conducted on 543 papers on various ferrous and ferric formulations used in the treatment of iron deficiency anemia. The study period is from 1977 to 2022, and the papers are identified from the Scopus database. The bibliometric analysis was carried out using the R tool's Bibliometrix package. The study discusses performance analysis, including annual publications, geographic analysis, relevant affiliations, journal analysis, and citation analysis. In addition, the conceptual structure, including the co-occurrence network, thematic map, thematic evolution, intellectual structure highlighting co-citation analysis, and social structure depicting the collaboration network and collaboration world map, are presented. The results showed increased research on formulation strategies for the treatment of iron deficiency anemia from 2010 onwards. The top 5 contributing countries are the USA, Italy, India, Germany, and the UK, and peer-reviewed journals from the area of nutrition. The most trending areas of study are iron deficiency anemia in pregnancy, chronic kidney diseases, inflammatory bowel diseases, and various intravenous formulations used in its treatment. The authors from Europe collaborate the most with authors from other countries. The study concludes that a safer and more effective iron formulation is needed to reduce the prevalence of anemia. The findings of the study are helpful in advancing research on innovative formulations for treating iron deficiency anemia. The insights from the study are helpful to policymakers in designing specific health policies and investing more in research and development of novel formulations for the treatment of iron deficiency anemia.
Collapse
Affiliation(s)
- Tarnjot Kaur
- Department of Pharmaceutical Sciences, School of Health Sciences and Technology, UPES, Bidholi Campus, Dehradun 248007, Uttarakhand, India
| | - Jyoti Upadhyay
- Department of Pharmaceutical Sciences, School of Health Sciences and Technology, UPES, Bidholi Campus, Dehradun 248007, Uttarakhand, India
| | - Mukesh Nandave
- Department of Pharmacology, Delhi Pharmaceutical Sciences and Research University New Delhi, 110017, India
| | - Abdulrhman Alsayari
- Department of Pharmacognosy, College of Pharmacy, King Khalid University, Abha 62529, Saudi Arabia
| | - Saad Ali Alshehri
- Department of Pharmacognosy, College of Pharmacy, King Khalid University, Abha 62529, Saudi Arabia
| | - Sudeep Pukale
- Lupin Research Park, Nande, Maharashtra 412115, India
| | - Shadma Wahab
- Department of Pharmacognosy, College of Pharmacy, King Khalid University, Abha 62529, Saudi Arabia
| | - Wasim Ahmad
- Department of Pharmacy, Mohammed Al-Mana College for Medical Sciences, Dammam 34222, Saudi Arabia
| | - Summya Rashid
- Department of Pharmacology & Toxicology, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-Kharj, 11942, Saudi Arabia
| | - Mohd Nazam Ansari
- Department of Pharmacology & Toxicology, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-Kharj, 11942, Saudi Arabia
| |
Collapse
|
12
|
Hashash JG, Elkins J, Lewis JD, Binion DG. AGA Clinical Practice Update on Diet and Nutritional Therapies in Patients With Inflammatory Bowel Disease: Expert Review. Gastroenterology 2024; 166:521-532. [PMID: 38276922 DOI: 10.1053/j.gastro.2023.11.303] [Citation(s) in RCA: 35] [Impact Index Per Article: 35.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/23/2023] [Revised: 09/19/2023] [Accepted: 11/05/2023] [Indexed: 01/27/2024]
Abstract
DESCRIPTION Diet plays a critical role in human health, but especially for patients with inflammatory bowel disease (IBD). Guidance about diet for patients with IBD are often controversial and a source of uncertainty for many physicians and patients. The role of diet has been investigated as a risk factor for IBD etiopathogenesis and as a therapy for active disease. Dietary restrictions, along with the clinical complications of IBD, can result in malnutrition, an underrecognized condition among this patient population. The aim of this American Gastroenterological Association (AGA) Clinical Practice Update (CPU) is to provide best practice advice statements, primarily to clinical gastroenterologists, covering the topics of diet and nutritional therapies in the management of IBD, while emphasizing identification and treatment of malnutrition in these patients. We provide guidance for tailored dietary approaches during IBD remission, active disease, and intestinal failure. A healthy Mediterranean diet will benefit patients with IBD, but may require accommodations for food texture in the setting of intestinal strictures or obstructions. New data in Crohn's disease supports the use of enteral liquid nutrition to help induce remission and correct malnutrition in patients heading for surgery. Parenteral nutrition plays a critical role in patients with IBD facing acute and/or chronic intestinal failure. Registered dietitians are an essential part of the interdisciplinary team approach for optimal nutrition assessment and management in the patient population with IBD. METHODS This expert review was commissioned and approved by the AGA Clinical Practice Updates Committee and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership and underwent internal peer review by the CPU Committee and external peer review through standard procedures of Gastroenterology. The best practice advice statements were drawn from reviewing existing literature combined with expert opinion to provide practical advice on the role of diet and nutritional therapies in patients with IBD. Because this was not a systematic review, formal rating of the quality of evidence or strength of the presented considerations was not performed. Best Practice Advice Statements BEST PRACTICE ADVICE 1: Unless there is a contraindication, all patients with IBD should be advised to follow a Mediterranean diet rich in a variety of fresh fruits and vegetables, monounsaturated fats, complex carbohydrates, and lean proteins and low in ultraprocessed foods, added sugar, and salt for their overall health and general well-being. No diet has consistently been found to decrease the rate of flares in adults with IBD. A diet low in red and processed meat may reduce ulcerative colitis flares, but has not been found to reduce relapse in Crohn's disease. BEST PRACTICE ADVICE 2: Patients with IBD who have symptomatic intestinal strictures may not tolerate fibrous, plant-based foods (ie, raw fruits and vegetables) due to their texture. An emphasis on careful chewing and cooking and processing of fruits and vegetables to a soft, less fibrinous consistency may help patients with IBD who have concomitant intestinal strictures incorporate a wider variety of plant-based foods and fiber in their diets. BEST PRACTICE ADVICE 3: Exclusive enteral nutrition using liquid nutrition formulations is an effective therapy for induction of clinical remission and endoscopic response in Crohn's disease, with stronger evidence in children than adults. Exclusive enteral nutrition may be considered as a steroid-sparing bridge therapy for patients with Crohn's disease. BEST PRACTICE ADVICE 4: Crohn's disease exclusion diet, a type of partial enteral nutrition therapy, may be an effective therapy for induction of clinical remission and endoscopic response in mild to moderate Crohn's disease of relatively short duration. BEST PRACTICE ADVICE 5: Exclusive enteral nutrition may be an effective therapy in malnourished patients before undergoing elective surgery for Crohn's disease to optimize nutritional status and reduce postoperative complications. BEST PRACTICE ADVICE 6: In patients with IBD who have an intra-abdominal abscess and/or phlegmonous inflammation that limits ability to achieve optimal nutrition via the digestive tract, short-term parenteral nutrition may be used to provide bowel rest in the preoperative phase to decrease infection and inflammation as a bridge to definitive surgical management and to optimize surgical outcomes. BEST PRACTICE ADVICE 7: We suggest the use of parenteral nutrition for high-output gastrointestinal fistula, prolonged ileus, short bowel syndrome, and for patients with IBD with severe malnutrition when oral and enteral nutrition has been trialed and failed or when enteral access is not feasible or contraindicated. BEST PRACTICE ADVICE 8: In patients with IBD and short bowel syndrome, long-term parenteral nutrition should be transitioned to customized hydration management (ie, intravenous electrolyte support and/or oral rehydration solutions) and oral intake whenever possible to decrease the risk of developing long-term complications. Treatment with glucagon-like peptide-2 agonists can facilitate this transition. BEST PRACTICE ADVICE 9: All patients with IBD warrant regular screening for malnutrition by their provider by means of assessing signs and symptoms, including unintended weight loss, edema and fluid retention, and fat and muscle mass loss. When observed, more complete evaluation for malnutrition by a registered dietitian is indicated. Serum proteins are no longer recommended for the identification and diagnosis of malnutrition due to their lack of specificity for nutritional status and high sensitivity to inflammation. BEST PRACTICE ADVICE 10: All patients with IBD should be monitored for vitamin D and iron deficiency. Patients with extensive ileal disease or prior ileal surgery (resection or ileal pouch) should be monitored for vitamin B12 deficiency. BEST PRACTICE ADVICE 11: All outpatients and inpatients with complicated IBD warrant co-management with a registered dietitian, especially those who have malnutrition, short bowel syndrome, enterocutaneous fistula, and/or are requiring more complex nutrition therapies (eg, parenteral nutrition, enteral nutrition, or exclusive enteral nutrition), or those on a Crohn's disease exclusion diet. We suggest that all newly diagnosed patients with IBD have access to a registered dietitian. BEST PRACTICE ADVICE 12: Breastfeeding is associated with a lower risk for diagnosis of IBD during childhood. A healthy, balanced, Mediterranean diet rich in a variety of fruits and vegetables and decreased intake of ultraprocessed foods have been associated with a lower risk of developing IBD.
Collapse
Affiliation(s)
- Jana G Hashash
- Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida.
| | - Jaclyn Elkins
- Department of Nutrition, Mayo Clinic, Jacksonville, Florida
| | - James D Lewis
- Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
| | - David G Binion
- Division of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh, Pittsburgh, Pennsylvania
| |
Collapse
|
13
|
Jin J, Ran Z, Noseda E, Roubert B, Marty M, Mezzacasa A, Göring UM. A randomized, controlled, open label non-inferiority trial of intravenous ferric carboxymaltose versus iron sucrose in patients with iron deficiency anemia in China. Front Med 2024; 18:98-108. [PMID: 37897561 DOI: 10.1007/s11684-023-1001-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/16/2022] [Accepted: 04/01/2023] [Indexed: 10/30/2023]
Abstract
Iron deficiency (ID) and ID anemia (IDA) pose significant public health concerns in China. Although iron sucrose (IS) treatment is well-established in the country, ferric carboxymaltose (FCM) offers the advantage of higher doses and fewer infusions. This 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 IDA. The 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 levels. Among 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 subjects. The safety profiles of FCM and IS were comparable, with the exception of transient hypophosphatemia and pyrexia, which are consistent with FCM's known safety profile. In conclusion, FCM proves to be an efficacious treatment for IDA, providing faster Hb-response and correction of ID with fewer administrations than IS.
Collapse
Affiliation(s)
- Jie Jin
- The First Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, 310058, China
| | - Zhihua Ran
- Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China
| | | | | | | | | | | |
Collapse
|
14
|
Bombač Tavčar L, Hrobat H, Gornik L, Preložnik Zupan I, Vidmar Šimic M, Pečlin P, Kavšek G, Lučovnik M. Maternal Fatigue after Postpartum Anemia Treatment with Intravenous Ferric Carboxymaltose vs. Intravenous Ferric Derisomaltose vs. Oral Ferrous Sulphate: A Randomized Controlled Trial. J Clin Med 2024; 13:758. [PMID: 38337452 PMCID: PMC10856024 DOI: 10.3390/jcm13030758] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/07/2023] [Revised: 01/22/2024] [Accepted: 01/24/2024] [Indexed: 02/12/2024] Open
Abstract
(1) Background: Postpartum anemia is a common maternal complication and is recognized as a cause of impaired quality of life, reduced cognitive abilities, and fatigue. Efficient iron supplementation for the treatment of postpartum anemia is an essential component of high-quality maternal care. The optimal mode of iron supplementation has not been determined yet, whether oral or intravenous. The objective of this study was to compare postpartum anemia treatment with intravenous ferric carboxymaltose, intravenous ferric derisomaltose, and oral ferrous sulfate. (2) Methods: A single-center, open-label, randomized controlled trial. Women with hemoglobin < 100 g/L within 48 h postpartum were randomly allocated to receive intravenous ferric carboxymaltose, intravenous ferric derisomaltose, or oral ferrous sulfate. Intravenous iron was given in one or two doses, while ferrous sulfate was given as two 80 mg tablets once daily. The primary outcome was maternal fatigue measured by the Multidimensional Fatigue Inventory (MFI) six weeks postpartum. Hemoglobin, ferritin, and transferrin saturation levels were analyzed as secondary outcomes. A Kruskal-Wallis test was used for group comparison (p < 0.05 significant). (3) Results: Three hundred women were included. The MFI score at six weeks postpartum did not differ between groups (median 38 (inter-quartile range (IQR) 29-47) in the ferric carboxymaltose group, median 34 (IQR 26-42) in the ferric derisomaltose group, and median 36 (IQR 25-47) in the ferrous sulfate group; p = 0.26). Participants receiving oral iron had lower levels of hemoglobin (135 (131-139) vs. 134 (129-139) vs. 131 (125-137) g/L; p = 0.008), ferritin (273 (198-377) vs. 187 (155-246) vs. 24 (17-37) µg/L; p < 0.001) and transferrin saturation (34 (28-38) vs. 30 (23-37) vs. 24 (17-37) %; p < 0.001) than those receiving ferric carboxymaltose or ferric derisomaltose. (4) Conclusions: Intravenous ferric carboxymaltose, intravenous ferric derisomaltose, and oral ferrous sulfate had similar impacts on maternal fatigue at six weeks postpartum despite improved laboratory parameters in the intravenous groups.
Collapse
Affiliation(s)
- Lea Bombač Tavčar
- Department of Perinatology, Division of Gynecology and Obstetrics, University Medical Centre Ljubljana, Šlajmerjeva 3, 1000 Ljubljana, Slovenia; (M.V.Š.); (P.P.); (G.K.); (M.L.)
- Faculty of Medicine, University of Ljubljana, Vrazov trg 2, 1000 Ljubljana, Slovenia; (H.H.); (L.G.); (I.P.Z.)
| | - Hana Hrobat
- Faculty of Medicine, University of Ljubljana, Vrazov trg 2, 1000 Ljubljana, Slovenia; (H.H.); (L.G.); (I.P.Z.)
| | - Lea Gornik
- Faculty of Medicine, University of Ljubljana, Vrazov trg 2, 1000 Ljubljana, Slovenia; (H.H.); (L.G.); (I.P.Z.)
| | - Irena Preložnik Zupan
- Faculty of Medicine, University of Ljubljana, Vrazov trg 2, 1000 Ljubljana, Slovenia; (H.H.); (L.G.); (I.P.Z.)
- Department of Hematology, University Medical Centre Ljubljana, Zaloška 7, 1000 Ljubljana, Slovenia
| | - Marijana Vidmar Šimic
- Department of Perinatology, Division of Gynecology and Obstetrics, University Medical Centre Ljubljana, Šlajmerjeva 3, 1000 Ljubljana, Slovenia; (M.V.Š.); (P.P.); (G.K.); (M.L.)
| | - Polona Pečlin
- Department of Perinatology, Division of Gynecology and Obstetrics, University Medical Centre Ljubljana, Šlajmerjeva 3, 1000 Ljubljana, Slovenia; (M.V.Š.); (P.P.); (G.K.); (M.L.)
| | - Gorazd Kavšek
- Department of Perinatology, Division of Gynecology and Obstetrics, University Medical Centre Ljubljana, Šlajmerjeva 3, 1000 Ljubljana, Slovenia; (M.V.Š.); (P.P.); (G.K.); (M.L.)
| | - Miha Lučovnik
- Department of Perinatology, Division of Gynecology and Obstetrics, University Medical Centre Ljubljana, Šlajmerjeva 3, 1000 Ljubljana, Slovenia; (M.V.Š.); (P.P.); (G.K.); (M.L.)
- Faculty of Medicine, University of Ljubljana, Vrazov trg 2, 1000 Ljubljana, Slovenia; (H.H.); (L.G.); (I.P.Z.)
| |
Collapse
|
15
|
Gordon H, Burisch J, Ellul P, Karmiris K, Katsanos K, Allocca M, Bamias G, Barreiro-de Acosta M, Braithwaite T, Greuter T, Harwood C, Juillerat P, Lobaton T, Müller-Ladner U, Noor N, Pellino G, Savarino E, Schramm C, Soriano A, Michael Stein J, Uzzan M, van Rheenen PF, Vavricka SR, Vecchi M, Zuily S, Kucharzik T. ECCO Guidelines on Extraintestinal Manifestations in Inflammatory Bowel Disease. J Crohns Colitis 2024; 18:1-37. [PMID: 37351850 DOI: 10.1093/ecco-jcc/jjad108] [Citation(s) in RCA: 45] [Impact Index Per Article: 45.0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/15/2023] [Indexed: 06/24/2023]
Affiliation(s)
- Hannah Gordon
- Department of Gastroenterology, Barts Health NHS Trust, London, Centre for Immunobiology, Blizard Institute, Faculty of Medicine, Barts & The London Medical School, Queen Mary University of London, UK
| | - Johan Burisch
- Gastrounit, medical division, Hvidovre Hospital, University of Copenhagen, Copenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, Hvidovre Hospital, University of Copenhagen, Denmark
| | - Pierre Ellul
- Department of Medicine, Division of Gastroenterology, Mater Dei Hospital, Msida, Malta
| | | | - Konstantinos Katsanos
- Department of Gastroenterology and Hepatology, Division of Internal Medicine, University and Medical School of Ioannina, Ioannina, Greece
| | - Mariangela Allocca
- Department of Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy
| | - Giorgos Bamias
- GI Unit, 3rd Academic Department of Internal Medicine, National and Kapodistrian University of Athens, Sotiria Hospital, Athens, Greece
| | - Manuel Barreiro-de Acosta
- University Hospital Santiago De Compostela CHUS, Department of Gastroenterology - IBD Unit, Santiago De Compostela, Spain
| | - Tasanee Braithwaite
- School of Immunology and Microbiology, King's College London, The Medical Eye Unit, Guy's and St Thomas' Hospital NHS Foundation Trust, London, UK
| | - Thomas Greuter
- Division of Gastroenterology and Hepatology, GZO - Zurich Regional Health Center, Wetzikon, Division of Gastroenterology and Hepatology, University Hospital Lausanne - CHUV, Lausanne, Switzerland; Department of Gastroenterology and Hepatology, University Hospital Zurich, Zurich, Switzerland
| | - Catherine Harwood
- Centre for Cell Biology and Cutaneous Research, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London; Department of Dermatology, Royal London Hospital, Barts Health NHS Trust, London, UK
| | - Pascal Juillerat
- Gastroenterology, Clinic for Visceral Surgery and Medicine, Bern University Hospital, Bern, Switzerland; Crohn and Colitis Center, Gastro-entérologie Beaulieu SA, Lausanne, Switzerland
| | - Triana Lobaton
- Department of Internal Medicine and Pediatrics, Ghent University, Ghent; Department of Gastroenterology, Ghent University Hospital, Ghent, Belgium
| | - Ulf Müller-Ladner
- Department of Rheumatology and Clinical Immunology, Campus Kerckhoff, Justus Liebig University Giessen, Bad Nauheim, Germany
| | - Nurulamin Noor
- Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
| | - Gianluca Pellino
- Vall d'Hebron University Hospital, Universitat Autonoma de Barcelona UAB, Barcelona, Spain; Department of Advanced Medical and Surgical Sciences, Università degli Studi della Campania 'Luigi Vanvitelli', Naples, Italy
| | - Edoardo Savarino
- Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy; Gastroenterology Unit, Azienda Ospedale Università di Padova, Padua, Italy
| | - Christoph Schramm
- Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Martin Zeitz Center for Rare Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Hamburg Center for Translational Immunology (HCTI), University Medical Center Hamburg-Eppendorf, Hamburg, Germany
| | - Alessandra Soriano
- Gastroenterology Division and IBD Center, Internal Medicine Department, Azienda Unità Sanitaria Locale - IRCCS, 42122 Reggio Emilia, Italy
| | - Jürgen Michael Stein
- Interdisciplinary Crohn Colitis Centre Rhein-Main, Frankfurt/Main, Department of Gastroenterology and Clinical Nutrition, DGD Clinics Sachsenhausen, Frankfurt/Main, Germany
| | - Mathieu Uzzan
- Department of Gastroenterology, Hôpital Henri Mondor, APHP, Créteil, France
| | - Patrick F van Rheenen
- Department of Paediatric Gastroenterology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands
| | - Stephan R Vavricka
- Department of Gastroenterology and Hepatology, University Hospital, Zurich, Switzerland
| | - Maurizio Vecchi
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy; Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy
| | - Stephane Zuily
- Vascular Medicine Division and French Referral Center for Rare Auto-Immune Diseases, Université de Lorraine, INSERM, DCAC and CHRU-Nancy, Nancy, France
| | - Torsten Kucharzik
- Department of Gastroenterology, Lüneburg Hospital, University of Münster, Lüneburg, Germany
| |
Collapse
|
16
|
Etemady M, Hajizadeh M, Gidaszewski B, Swain JA, Chua SC, Khajehei M. Use of iron in perinatal anaemia: Indications for women’s health care policies and procedure. World J Obstet Gynecol 2023; 12:33-44. [DOI: 10.5317/wjog.v12.i4.33] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/24/2023] [Revised: 10/04/2023] [Accepted: 11/24/2023] [Indexed: 12/28/2023] Open
Abstract
This paper reviews management of obstetric anaemia and the role of intravenous iron for the treatment of obstetric anaemia. Red blood cell transfusions are routinely used for haemoglobin restoration in anaemic women. The decision for red blood cell transfusion is made on a combination of haemoglobin level and clinical status, and it is suggested that transfusions are not necessary in those who are well compensated or when alternative therapy is available. To reduce the risk, intravenous iron infusion is proposed as a bloodless therapeutic approach. There are a variety of iron preparations. Intravenous iron infusion can reduce the requirement for blood transfusion in hemodynamically stable women with perinatal anaemia, especially in resource-scarce settings. It a cost-effective bloodless approach for the treatment of anaemia than can enhance patient outcomes. According to the literature, when haemoglobin is greater than 90 g/L, blood transfusion is not often required. In perinatal women with anaemia, the decision whether to administer blood or iron is based on patient preferences, haemoglobin levels, clinical symptoms, past and present medical conditions and the clinician’s judgement. Nevertheless, due to the lack of rigid criteria for blood transfusions in the majority of clinical settings, it is considered the default treatment for anaemia in perinatal women.
Collapse
Affiliation(s)
- Mike Etemady
- School of Health Sciences, University of Sydney, Sydney, Australia, Sydney 2000, NSW, Australia
| | - Melika Hajizadeh
- Stotts College, Acknowledge Education, Sydney 2000, NSW, Australia
| | - Beata Gidaszewski
- Department of Women’s and Newborn Health, Westmead Hospital, Westmead 2145, NSW, Australia
- Westmead Clinical School, University of Sydney, Sydney 2000, NSW, Australia
| | - Julie Ann Swain
- Women's and Newborn Health, Westmead hospital, Westmead 2145, NSW, Australia
| | - Seng Chai Chua
- Department of Women’s and Newborn Health, Westmead Hospital, Westmead 2145, NSW, Australia
- Clinical School, Western Sydney University, Sydney 2145, NSW, Australia
| | - Marjan Khajehei
- Department of Women’s and Newborn Health, Westmead Hospital, Westmead 2145, NSW, Australia
- Westmead Clinical School, University of Sydney, Sydney 2000, NSW, Australia
- School of Women’s and Children’s Health, University of New South Wales, Sydney 2145, NSW, Australia
| |
Collapse
|
17
|
Van Doren L, Auerbach M. IV iron formulations and use in adults. HEMATOLOGY. AMERICAN SOCIETY OF HEMATOLOGY. EDUCATION PROGRAM 2023; 2023:622-629. [PMID: 38066930 PMCID: PMC10727060 DOI: 10.1182/hematology.2023000495] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/18/2023]
Abstract
Intravenous iron has become a major component of the therapeutic armamentarium for iron deficiency and iron deficiency anemia. The earliest formulations were associated with unacceptable toxicity. Newer formulations, with complex carbohydrate cores that bind elemental iron more tightly, allow the administration of full therapeutic doses in 15 to 60 minutes. Nonetheless, a folklore of danger, fueled by earlier formulations no longer available, continues to foment caution. Complement-mediated minor infusion reactions, referred to as complement activation-related pseudo-allergy, resolve without therapy. Inappropriate intervention with vasopressors and H1 blockers converts these minor reactions into hemodynamically significant adverse events. Four new formulations, low-molecular-weight iron dextran, ferumoxytol, ferric carboxymaltose, and ferric derisomaltose, all approved for the treatment of iron deficiency in a host of conditions, are now widely used with an excellent safety profile. Herein, the administration, safety, indications, and management of infusion reactions are discussed. Treatment-emergent hypophosphatemia, a newly recognized side effect for some formulations, is also reviewed. Based on the preponderance of published evidence, intravenous iron should be moved up-front for the treatment of iron deficiency and iron deficiency anemia in those conditions in which oral iron is suboptimal.
Collapse
Affiliation(s)
- Layla Van Doren
- Division of Hematology, Yale School of Medicine, New Haven, CT
| | - Michael Auerbach
- Division of Hematology, Georgetown School of Medicine, Baltimore, MD
| |
Collapse
|
18
|
Choi KY, Kim YD, Cho N, Kim MS, In Y, You HY, Koh IJ. Postoperative Hemodynamics of Total Knee Arthroplasty Unaffected by Cementless Approach under Contemporary Patient Blood Management Protocol: A Propensity Score-Matched Study. J Clin Med 2023; 12:6980. [PMID: 38002595 PMCID: PMC10672580 DOI: 10.3390/jcm12226980] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/20/2023] [Revised: 10/18/2023] [Accepted: 11/07/2023] [Indexed: 11/26/2023] Open
Abstract
(1) Background: A cementless total knee arthroplasty (TKA) is a recent and an increasingly popular innovation that enhances porous fixation surfaces. However, the lack of cemented sealing of an exposed resected bone has raised concerns about the potential for greater blood loss. The goals of this study were to determine if a cementless approach impacts post-TKA hemodynamics and to identify risk factors for blood loss in instances of cementless (vs. cemented) TKAs under a contemporary patient blood management (PBM) protocol. (2) Methods: We recruited 153 consecutive patients undergoing unilateral TKAs between 2019 and 2023. All enrollees received cementless or cemented prostheses of the same design (cementless, 87; cemented, 66). After propensity score matching for demographics, there were 46 patients in each group. We then compared blood loss metrics (total [TBL] and estimated [EBL]), drainage volumes, hemoglobin (Hb) levels, and transfusion rates by group. (3) Results: Post-TKA hemodynamics (i.e., TBL, EBL, drainage, Hb level, and transfusion rate) of cementless (n = 46) and cemented (n = 46) TKA groups did not differ significantly. In addition, the proportions of patients with Hb drops > 3.0 g/dL were similar for the two groups. A logistic regression analysis revealed that only preoperative Hb and EBL during the early postoperative period were predictive of a substantial fall in Hb levels. The fixation method was not associated with Hb decline > 3.0 g/dL by postoperative Day 3. (4) Conclusion: The cementless TKA has no impact on customary post-TKA hemodynamics and is not associated with greater TKA-related blood loss when implementing a contemporary PBM protocol.
Collapse
Affiliation(s)
- Keun Young Choi
- Department of Orthopaedic Surgery, Seoul St. Mary’s Hospital, Seoul 06591, Republic of Korea; (K.Y.C.); (M.S.K.); (Y.I.)
- Department of Orthopaedic Surgery, College of Medicine, The Catholic University of Korea, Seoul 06591, Republic of Korea; (Y.D.K.); (H.Y.Y.)
| | - Yong Deok Kim
- Department of Orthopaedic Surgery, College of Medicine, The Catholic University of Korea, Seoul 06591, Republic of Korea; (Y.D.K.); (H.Y.Y.)
- Joint Replacement Center, Eunpyeong St. Mary’s Hospital, Seoul 03312, Republic of Korea
| | - Nicole Cho
- Lauren E. Wiznia MD PLLC, 1016 Fifth Avenue, New York, NY 10028, USA;
| | - Man Soo Kim
- Department of Orthopaedic Surgery, Seoul St. Mary’s Hospital, Seoul 06591, Republic of Korea; (K.Y.C.); (M.S.K.); (Y.I.)
- Department of Orthopaedic Surgery, College of Medicine, The Catholic University of Korea, Seoul 06591, Republic of Korea; (Y.D.K.); (H.Y.Y.)
| | - Yong In
- Department of Orthopaedic Surgery, Seoul St. Mary’s Hospital, Seoul 06591, Republic of Korea; (K.Y.C.); (M.S.K.); (Y.I.)
- Department of Orthopaedic Surgery, College of Medicine, The Catholic University of Korea, Seoul 06591, Republic of Korea; (Y.D.K.); (H.Y.Y.)
| | - Hwang Yong You
- Department of Orthopaedic Surgery, College of Medicine, The Catholic University of Korea, Seoul 06591, Republic of Korea; (Y.D.K.); (H.Y.Y.)
- Joint Replacement Center, Eunpyeong St. Mary’s Hospital, Seoul 03312, Republic of Korea
| | - In Jun Koh
- Department of Orthopaedic Surgery, College of Medicine, The Catholic University of Korea, Seoul 06591, Republic of Korea; (Y.D.K.); (H.Y.Y.)
- Joint Replacement Center, Eunpyeong St. Mary’s Hospital, Seoul 03312, Republic of Korea
| |
Collapse
|
19
|
Dottori L, Corleone Tsar'kov D, Dilaghi E, Pivetta G, Scalamonti S, Ligato I, Esposito G, Annibale B, Lahner E. Efficacy and Safety of Intravenous Ferric Carboxymaltose Treatment of Iron Deficiency Anaemia in Patients with Corpus Atrophic Gastritis: A Retrospective Study. Nutrients 2023; 15:4199. [PMID: 37836482 PMCID: PMC10574262 DOI: 10.3390/nu15194199] [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: 08/06/2023] [Revised: 09/26/2023] [Accepted: 09/27/2023] [Indexed: 10/15/2023] Open
Abstract
Corpus Atrophic Gastritis (CAG) is characterised by iron malabsorption leading to iron deficiency anaemia (IDA), which rarely responds to oral therapy. Ferric carboxymaltose (FCM), shown to be a safe and effective intravenous iron therapy in other diseases, has not been investigated yet in CAG. Thus, we aimed to assess the safety and efficacy of FCM in CAG-related IDA. A retrospective study on 91 patients identified CAG as the only cause of IDA treated with FCM. Twenty-three were excluded for incomplete follow-up. Sixty-eight were evaluated for safety and efficacy, while three were evaluated for safety only due to infusion interruption for side effects. Haemoglobin and iron storage were evaluated pre-infusion (T0), at 4 weeks (T4) and 12 weeks (T12) after infusion. An eventual IDA relapse was analysed. Two cases reported mild side effects. Haemoglobin significantly increased at T4, and T12, reaching +3.1 g/dL. Ferritin increased at T4, decreasing at T12, while transferrin saturation increased progressively until reaching a plateau. IDA relapsed in 55.4% of patients at a mean of 24.6 months. The only factor associated with relapse was female gender [OR (95% CI): 6.6 (1.5-28.6)]. FCM proved to be safe and effective in treating CAG-related IDA, ensuring quick and long-lasting recovery.
Collapse
Affiliation(s)
| | | | | | | | | | | | | | | | - Edith Lahner
- Department of Medical-Surgical Sciences and Translational Medicine, Sant’Andrea Hospital, Sapienza University of Rome, 00189 Rome, Italy (G.E.); (B.A.)
| |
Collapse
|
20
|
Grino M, Rigaux M, Lagarde AV, Robert V, Papailhau C, Vincentelli MB. [Hypophosphatemia after injectable iron treatments in adults: Comparison between ferric carboxymaltose and iron sucrose]. ANNALES PHARMACEUTIQUES FRANÇAISES 2023; 81:790-800. [PMID: 36963655 DOI: 10.1016/j.pharma.2023.03.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/23/2023] [Revised: 03/13/2023] [Accepted: 03/20/2023] [Indexed: 03/26/2023]
Abstract
Hypophosphatemia is a recognized side effect of treatment of iron deficiency anemias with injectable iron. We analyzed 35 clinical trials that used ferric carboxymaltose (FCM) or iron sucrose (IS). Hypophosphatemia prevalence ranged from 0 to 91.7%. FCM-induced a significant (P<0.001) greater hypophosphatemia prevalence and phosphatemia decrease than IS (52.0% [95% CI: 42.2-61.8%] vs. 7.7% [95% CI: -2.8 to 18.2%] and -1.12mmol/L [95% CI: -1.36 to -0.89mmol/L] vs. -0.13mmol/L [95% CI: -0.59 to 0.32mmol/L]). FCM-induced hypophosphatemia was dose-dependent. The nadir of hypophosphatemia was reached in almost all studies after 7 and 14days. Hypophosphatemia persisted at the end of the study in 53.8% of the reported studies that used FCM and lasted up to 6months. FCM-induced an increase in intact circulating fibroblast growth factor 23 and in renal phosphorus excretion while serum 1-25 dihydroxyvitamin D was decreased. Risk factors for hypophosphatemia after FCM therapy were low basal circulating phosphate or ferritin, low body weight, high glomerular filtration rate, serum parathyroid hormone or hemoglobin and age, whereas renal insufficiency was associated with a lower risk. In conclusion, hypophosphatemia is common after treatment with injectable iron, FCM being associated with a higher risk than IS and with disorders of phosphocalcium metabolism. Monitoring of blood phosphate and 1-25 dihydroxyvitamin D could be considered during FCM therapy.
Collapse
Affiliation(s)
- Michel Grino
- Département de recherche clinique, Centre gérontologique départemental de Marseille, 176, avenue de Montolivet, 13012 Marseille, France.
| | - Marine Rigaux
- Pharmacie à usage intérieur, Centre gérontologique départemental de Marseille, 176, avenue de Montolivet, 13012 Marseille, France
| | - Anne-Violette Lagarde
- Pharmacie à usage intérieur, Centre gérontologique départemental de Marseille, 176, avenue de Montolivet, 13012 Marseille, France
| | - Vincent Robert
- Pharmacie à usage intérieur, Centre gérontologique départemental de Marseille, 176, avenue de Montolivet, 13012 Marseille, France
| | - Charlotte Papailhau
- Pharmacie à usage intérieur, Centre gérontologique départemental de Marseille, 176, avenue de Montolivet, 13012 Marseille, France
| | - Marie-Bénédicte Vincentelli
- Pharmacie à usage intérieur, Centre gérontologique départemental de Marseille, 176, avenue de Montolivet, 13012 Marseille, France
| |
Collapse
|
21
|
Zoller H, Wagner S, Schaefer B. What is wrong in doing good? Br J Haematol 2023; 202:1089-1090. [PMID: 37528542 DOI: 10.1111/bjh.19019] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/24/2023] [Accepted: 07/25/2023] [Indexed: 08/03/2023]
Abstract
Hypophosphataemia is a common side-effect in patients with iron deficiency anaemia treated with ferric carboxymaltose, which is not a class effect of all intravenous (IV) iron formulations. The report by Chu et al. shows that moderate and severe hypophosphataemia is common and can even require IV supplementation of phosphate with unknown long-term consequences. Commentary on: Chu et al. Incidence and predictors of hypophosphataemia after ferric carboxymaltose use-a 3-year experience from a single institution in Singapore. Br J Haematol 2023;202:1199-1204.
Collapse
Affiliation(s)
- Heinz Zoller
- Christian Doppler Laboratory on Iron and Phosphate Biology, Department of Medicine I, Medical University of Innsbruck, Innsbruck, Austria
| | - Sonja Wagner
- Christian Doppler Laboratory on Iron and Phosphate Biology, Department of Medicine I, Medical University of Innsbruck, Innsbruck, Austria
| | - Benedikt Schaefer
- Christian Doppler Laboratory on Iron and Phosphate Biology, Department of Medicine I, Medical University of Innsbruck, Innsbruck, Austria
| |
Collapse
|
22
|
Kucharzik T, Dignass A, Atreya R, Bokemeyer B, Esters P, Herrlinger K, Kannengiesser K, Kienle P, Langhorst J, Lügering A, Schreiber S, Stallmach A, Stein J, Sturm A, Teich N, Siegmund B. Aktualisierte S3-Leitlinie Colitis ulcerosa (Version 6.1) – Februar 2023 – AWMF-Registriernummer: 021-009. ZEITSCHRIFT FUR GASTROENTEROLOGIE 2023; 61:1046-1134. [PMID: 37579791 DOI: 10.1055/a-2060-0935] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 08/16/2023]
Affiliation(s)
- T Kucharzik
- Klinik für Allgemeine Innere Medizin und Gastroenterologie, Städtisches Klinikum Lüneburg, Lüneburg, Deutschland
| | - A Dignass
- Medizinische Klinik I, Agaplesion Markus Krankenhaus, Frankfurt, Deutschland
| | - R Atreya
- Medizinische Klinik 1 Gastroent., Pneumologie, Endokrin., Universitätsklinikum Erlangen, Erlangen, Deutschland
| | - B Bokemeyer
- Interdisziplinäres Crohn Colitis Centrum Minden - ICCCM, Minden, Deutschland
| | - P Esters
- Medizinische Klinik I, Agaplesion Markus Krankenhaus, Frankfurt, Deutschland
| | - K Herrlinger
- Innere Medizin I, Asklepios Klinik Nord, Hamburg, Deutschland
| | - K Kannengiesser
- Klinik für Allgemeine Innere Medizin und Gastroenterologie, Städtisches Klinikum Lüneburg, Lüneburg, Deutschland
| | - P Kienle
- Abteilung für Allgemein- und Viszeralchirurgie, Theresienkrankenhaus, Mannheim, Deutschland
| | - J Langhorst
- Klinik für Integrative Medizin und Naturheilkunde, Sozialstiftung Bamberg Klinikum am Bruderwald, Bamberg, Deutschland
| | - A Lügering
- Medizinisches Versorgungszentrum Portal 10, Münster, Deutschland
| | - S Schreiber
- Klinik für Innere Medizin I, Universitätsklinikum Schleswig Holstein, Kiel, Deutschland
| | - A Stallmach
- Klinik für Innere Medizin IV Gastroenterologie, Hepatologie, Infektiologie, Universitätsklinikum Jena, Jena, Deutschland
| | - J Stein
- Abteilung Innere Medizin mit Schwerpunkt Gastroenterologie, Krankenhaus Sachsenhausen, Frankfurt, Deutschland
| | - A Sturm
- Klinik für Innere Medizin mit Schwerpunkt Gastroenterologie, DRK Kliniken Berlin Westend, Berlin, Deutschland
| | - N Teich
- Internistische Gemeinschaftspraxis, Leipzig, Deutschland
| | - B Siegmund
- Medizinische Klinik für Gastroenterologie, Infektiologie und Rheumatologie, Charité Campus Benjamin Franklin - Universitätsmedizin Berlin, Berlin, Deutschland
| |
Collapse
|
23
|
Plumb JOM, Otto JM, Kumar SB, Bali S, Wakatsuki M, Schmidt WFJ, Montgomery HE, Grocott MPW, Levett DZ. Cardiopulmonary exercise testing before and after intravenous iron in preoperative patients: a prospective clinical study. Perioper Med (Lond) 2023; 12:31. [PMID: 37400931 DOI: 10.1186/s13741-023-00319-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/23/2022] [Accepted: 06/16/2023] [Indexed: 07/05/2023] Open
Abstract
BACKGROUND Anemia is associated with impaired physical performance and adverse perioperative outcomes. Iron-deficiency anemia is increasingly treated with intravenous iron before elective surgery. We explored the relationship between exercise capacity, anemia, and total hemoglobin mass (tHb-mass) and the response to intravenous iron in anemic patients prior to surgery. METHODS A prospective clinical study was undertaken in patients having routine cardiopulmonary exercise testing (CPET) with a hemoglobin concentration ([Hb]) < 130 g.l-1 and iron deficiency/depletion. Patients underwent CPET and tHb-mass measurements before and a minimum of 14 days after receiving intravenous (i.v.) Ferric derisomaltose (Monofer®) at the baseline visit. Comparative analysis of hematological and CPET variables was performed pre and post-iron treatment. RESULTS Twenty-six subjects were recruited, of whom 6 withdrew prior to study completion. The remaining 20 (9 [45%] male; mean ± SD age 68 ± 10 years) were assessed 25 ± 7 days between baseline and the final visit. Following i.v. iron, increases were seen in [Hb] (mean ± SD) from 109 ± 14 to 116 ± 12 g l-1 (mean rise 6.4% or 7.3 g l-1, p = < 0.0001, 95% CI 4.5-10.1); tHb-mass from 497 ± 134 to 546 ± 139 g (mean rise 9.3% or 49 g, p = < 0.0001, 95% CI 29.4-69.2). Oxygen consumption at anerobic threshold ([Formula: see text] O2 AT) did not change (9.1 ± 1.7 to 9.8 ± 2.5 ml kg-1 min-1, p = 0.09, 95% CI - 0.13 - 1.3). Peak oxygen consumption ([Formula: see text] O2 peak) increased from 15.2 ± 4.1 to 16 ± 4.4 ml.kg.-1 min-1, p = 0.02, 95% CI 0.2-1.8) and peak work rate increased from 93 [67-112] watts to 96 [68-122] watts (p = 0.02, 95% CI 1.3-10.8). CONCLUSION Preoperative administration of intravenous iron to iron-deficient/deplete anemic patients is associated with increases in [Hb], tHb-mass, peak oxygen consumption, and peak work rate. Further appropriately powered prospective studies are required to ascertain whether improvements in tHb-mass and performance in turn lead to reductions in perioperative morbidity. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT 033 46213.
Collapse
Affiliation(s)
- James O M Plumb
- Perioperative and Critical Care Theme, NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust/University of Southampton, Southampton, UK.
- Centre for Human Integrative Physiology, Faculty of Medicine, University of Southampton, Southampton, UK.
- Anaesthesia and Critical Care Research Unit, University Hospital Southampton NHSFT, Southampton, UK.
- Shackleton Department of Anaesthesia, University Hospital Southampton NHSFT, Southampton, UK.
| | - James M Otto
- Perioperative and Critical Care Theme, NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust/University of Southampton, Southampton, UK
- Centre for Human Integrative Physiology, Faculty of Medicine, University of Southampton, Southampton, UK
- Anaesthesia and Critical Care Research Unit, University Hospital Southampton NHSFT, Southampton, UK
- Shackleton Department of Anaesthesia, University Hospital Southampton NHSFT, Southampton, UK
| | - Shriya B Kumar
- Perioperative and Critical Care Theme, NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust/University of Southampton, Southampton, UK
| | - Sitara Bali
- Perioperative and Critical Care Theme, NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust/University of Southampton, Southampton, UK
| | - Mai Wakatsuki
- Shackleton Department of Anaesthesia, University Hospital Southampton NHSFT, Southampton, UK
| | - Walter F J Schmidt
- Department of, Sports Medicine/Sports Physiology, University of Bayreuth, Bayreuth, Germany
| | - Hugh E Montgomery
- Centre for Human Health and Performance/Institute of Sport, Exercise and Health, University College London, London, UK
- NIHR University College London Hospitals Biomedical Research Centre, London, UK
| | - Michael P W Grocott
- Perioperative and Critical Care Theme, NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust/University of Southampton, Southampton, UK
- Centre for Human Integrative Physiology, Faculty of Medicine, University of Southampton, Southampton, UK
- Anaesthesia and Critical Care Research Unit, University Hospital Southampton NHSFT, Southampton, UK
- Shackleton Department of Anaesthesia, University Hospital Southampton NHSFT, Southampton, UK
- Department of Anesthesiology, Duke University School of Medicine, Durham, NC, USA
| | - Denny Z Levett
- Perioperative and Critical Care Theme, NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust/University of Southampton, Southampton, UK
- Centre for Human Integrative Physiology, Faculty of Medicine, University of Southampton, Southampton, UK
- Anaesthesia and Critical Care Research Unit, University Hospital Southampton NHSFT, Southampton, UK
- Shackleton Department of Anaesthesia, University Hospital Southampton NHSFT, Southampton, UK
| |
Collapse
|
24
|
Siqueira NSN, Pascoal LB, Rodrigues BL, de Castro MM, Martins ASC, Araújo DOS, Gomes LEM, Camargo MG, Ayrizono MDLS, Leal RF. Ferric carboxymaltose for anemia in Crohn’s disease patients at a tertiary center: A retrospective observational cohort study. World J Clin Cases 2023; 11:2740-2752. [PMID: 37214580 PMCID: PMC10198098 DOI: 10.12998/wjcc.v11.i12.2740] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/28/2022] [Revised: 02/20/2023] [Accepted: 03/23/2023] [Indexed: 04/25/2023] Open
Abstract
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 common. Intravenous (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 challenging.
AIM 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 treatment.
METHODS This retrospective observational study included 25 patients with active CD, severe anemia, and refractory to previous conventional treatments. Patients were evaluated two times: During the last treatment with ferric hydroxide sucrose and treatment with FCM.
RESULTS After treatment with FCM, parameters of IDA assessment significantly improved, serum hemoglobin (Hb) levels increased in 93% of patients (P < 0.0001), and in 44%, there was an increase of ≥ 2 g/dL in a single application. In addition, 86% of the patients showed an increase in serum iron (P < 0.0001) and ferritin (P = 0.0008) and 50% in transferrin saturation (P = 0.01). The serum iron levels at baseline showed a negative association with the ileal and colonic CD and use of biologics and a positive association with patients who developed CD later in life after the age of 40 (A3) and with a stenosing (B2) and fistulizing (B3) phenotype. The values of Hb and hematocrit after ferric hydroxide sucrose treatment remained similar to those found before treatment.
CONCLUSION This study demonstrated that FCM is an important therapeutic strategy for treating IDA in CD patients, achieving satisfactory results in refractory cases.
Collapse
Affiliation(s)
- Natália Souza Nunes Siqueira
- Inflammatory Bowel Disease Research Laboratory, Gastrocenter, Colorectal Surgery Unit, School of Medical Sciences, University of Campinas (Unicamp), Campinas 13083-878, São Paulo, Brazil
| | - Livia Bitencourt Pascoal
- Inflammatory Bowel Disease Research Laboratory, Gastrocenter, Colorectal Surgery Unit, School of Medical Sciences, University of Campinas (Unicamp), Campinas 13083-878, São Paulo, Brazil
| | - Bruno Lima Rodrigues
- Inflammatory Bowel Disease Research Laboratory, Gastrocenter, Colorectal Surgery Unit, School of Medical Sciences, University of Campinas (Unicamp), Campinas 13083-878, São Paulo, Brazil
| | - Marina Moreira de Castro
- Inflammatory Bowel Disease Research Laboratory, Gastrocenter, Colorectal Surgery Unit, School of Medical Sciences, University of Campinas (Unicamp), Campinas 13083-878, São Paulo, Brazil
| | - Alan Sidnei Corrêa Martins
- Inflammatory Bowel Disease Research Laboratory, Gastrocenter, Colorectal Surgery Unit, School of Medical Sciences, University of Campinas (Unicamp), Campinas 13083-878, São Paulo, Brazil
| | - Dante Orsetti Silva Araújo
- Inflammatory Bowel Disease Research Laboratory, Gastrocenter, Colorectal Surgery Unit, School of Medical Sciences, University of Campinas (Unicamp), Campinas 13083-878, São Paulo, Brazil
| | - Luis Eduardo Miani Gomes
- Inflammatory Bowel Disease Research Laboratory, Gastrocenter, Colorectal Surgery Unit, School of Medical Sciences, University of Campinas (Unicamp), Campinas 13083-878, São Paulo, Brazil
| | - Michel Gardere Camargo
- Inflammatory Bowel Disease Research Laboratory, Gastrocenter, Colorectal Surgery Unit, School of Medical Sciences, University of Campinas (Unicamp), Campinas 13083-878, São Paulo, Brazil
| | - Maria de Lourdes Setsuko Ayrizono
- Inflammatory Bowel Disease Research Laboratory, Gastrocenter, Colorectal Surgery Unit, School of Medical Sciences, University of Campinas (Unicamp), Campinas 13083-878, São Paulo, Brazil
| | - Raquel Franco Leal
- Inflammatory Bowel Disease Research Laboratory, Gastrocenter, Colorectal Surgery Unit, School of Medical Sciences, University of Campinas (Unicamp), Campinas 13083-878, São Paulo, Brazil
| |
Collapse
|
25
|
Zoller H, Wolf M, Blumenstein I, Primas C, Lindgren S, Thomsen LL, Reinisch W, Iqbal T. Hypophosphataemia following ferric derisomaltose and ferric carboxymaltose in patients with iron deficiency anaemia due to inflammatory bowel disease (PHOSPHARE-IBD): a randomised clinical trial. Gut 2023; 72:644-653. [PMID: 36343979 PMCID: PMC10086283 DOI: 10.1136/gutjnl-2022-327897] [Citation(s) in RCA: 21] [Impact Index Per Article: 10.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/19/2022] [Accepted: 08/20/2022] [Indexed: 12/08/2022]
Abstract
OBJECTIVE Intravenous iron-a common treatment for anaemia and iron deficiency due to inflammatory bowel disease (IBD)-can cause hypophosphataemia. This trial compared the incidence of hypophosphataemia after treatment with ferric carboxymaltose (FCM) or ferric derisomaltose (FDI). DESIGN This randomised, double-blind, clinical trial was conducted at 20 outpatient hospital clinics in Europe (Austria, Denmark, Germany, Sweden, UK). Adults with IBD and iron deficiency anaemia (IDA) were randomised 1:1 to receive FCM or FDI at baseline and at Day 35 using identical haemoglobin- and weight-based dosing regimens. The primary outcome was the incidence of hypophosphataemia (serum phosphate <2.0 mg/dL) at any time from baseline to Day 35 in the safety analysis set (all patients who received ≥1 dose of study drug). Markers of mineral and bone homeostasis, and patient-reported fatigue scores, were measured. RESULTS A total of 156 patients were screened; 97 (49 FDI, 48 FCM) were included and treated. Incident hypophosphataemia occurred in 8.3% (4/48) FDI-treated patients and in 51.0% (25/49) FCM-treated patients (adjusted risk difference: -42.8% (95% CI -57.1% to -24.6%) p<0.0001). Both iron formulations corrected IDA. Patient-reported fatigue scores improved in both groups, but more slowly and to a lesser extent with FCM than FDI; slower improvement in fatigue was associated with greater decrease in phosphate concentration. CONCLUSION Despite comparably effective treatment of IDA, FCM caused a significantly higher rate of hypophosphataemia than FDI. Further studies are needed to address the longer-term clinical consequences of hypophosphataemia and to investigate mechanisms underpinning the differential effects of FCM and FDI on patient-reported fatigue.
Collapse
Affiliation(s)
- Heinz Zoller
- Department of Medicine I and Christian Doppler Laboratory on Iron and Phosphate Biology, Medical University of Innsbruck, Innsbruck, Austria
| | - Myles Wolf
- Division of Nephrology, Department of Medicine, and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA
| | - Irina Blumenstein
- Medical Clinic I, Department of Gastroenterology, Hepatology, and Clinical Nutrition, University Clinic Frankfurt, Frankfurt, Germany
| | - Christian Primas
- Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria
| | - Stefan Lindgren
- Department of Gastroenterology and Hepatology, Skåne University Hospital Malmö, Lund University, Lund, Sweden
| | - Lars L Thomsen
- Department of Clinical and Non-Clinical Research, Pharmacosmos A/S, Holbæk, Denmark
| | - Walter Reinisch
- Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria
| | - Tariq Iqbal
- Department of Gastroenterology, Queen Elizabeth Hospital Birmingham, Birmingham, UK
| |
Collapse
|
26
|
Bischoff SC, Bager P, Escher J, Forbes A, Hébuterne X, Hvas CL, Joly F, Klek S, Krznaric Z, Ockenga J, Schneider S, Shamir R, Stardelova K, Bender DV, Wierdsma N, Weimann A. ESPEN guideline on Clinical Nutrition in inflammatory bowel disease. Clin Nutr 2023; 42:352-379. [PMID: 36739756 DOI: 10.1016/j.clnu.2022.12.004] [Citation(s) in RCA: 103] [Impact Index Per Article: 51.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/05/2022] [Accepted: 12/05/2022] [Indexed: 01/15/2023]
Abstract
The present guideline is an update and extension of the ESPEN scientific guideline on Clinical Nutrition in Inflammatory Bowel Disease published first in 2017. The guideline has been rearranged according to the ESPEN practical guideline on Clinical Nutrition in Inflammatory Bowel Disease published in 2020. All recommendations have been checked and, if needed, revised based on new literature, before they underwent the ESPEN consensus procedure. Moreover, a new chapter on microbiota modulation as a new option in IBD treatment has been added. The number of recommendations has been increased to 71 recommendations in the guideline update. The guideline is aimed at professionals working in clinical practice, either in hospitals or in outpatient medicine, and treating patients with IBD. General aspects of care in patients with IBD, and specific aspects during active disease and in remission are addressed. All recommendations are equipped with evidence grades, consensus rates, short commentaries and links to cited literature.
Collapse
Affiliation(s)
- Stephan C Bischoff
- Institute of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany.
| | - Palle Bager
- Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.
| | - Johanna Escher
- Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, the Netherlands.
| | - Alastair Forbes
- Institute of Clinical Medicine, University of Tartu, Tartu, Estonia.
| | - Xavier Hébuterne
- Department of Gastroenterology and Clinical Nutrition, CHU of Nice, University Côte d'Azur, Nice, France.
| | - Christian Lodberg Hvas
- Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.
| | - Francisca Joly
- Department of Gastroenterology and Nutrition Support, CHU de Beaujon, APHP, University of Paris, Paris, France.
| | - Stansilaw Klek
- Surgical Oncology Clinic, Maria Sklodowska-Curie National Cancer Institute, Krakow, Poland.
| | - Zeljko Krznaric
- Department of Gastroenterology, Hepatology and Nutrition, University Hospital Centre Zagreb, University of Zagreb, Croatia.
| | - Johann Ockenga
- Medizinische Klinik II, Klinikum Bremen-Mitte, Bremen FRG, Bremen, Germany.
| | - Stéphane Schneider
- Department of Gastroenterology and Clinical Nutrition, CHU de Nice, University Côte d'Azur, Nice, France.
| | - Raanan Shamir
- Institute for Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center of Israel, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
| | - Kalina Stardelova
- University Clinic for Gastroenterohepatology, Clinical Campus "Mother Theresa", University St Cyrul and Methodius, Skopje, North Macedonia.
| | - Darija Vranesic Bender
- Unit of Clinical Nutrition, Department of Internal Medicine, University Hospital Centre Zagreb, Zagreb, Croatia.
| | - Nicolette Wierdsma
- Department of Nutrition and Dietetics, Amsterdam University Medical Centers, Amsterdam, the Netherlands.
| | - Arved Weimann
- Department of General, Visceral and Oncological Surgery, St. George Hospital, Leipzig, Germany.
| |
Collapse
|
27
|
Maas LA, Krishna M, Parian AM. Ironing It All Out: A Comprehensive Review of Iron Deficiency Anemia in Inflammatory Bowel Disease Patients. Dig Dis Sci 2023; 68:357-369. [PMID: 35930123 DOI: 10.1007/s10620-022-07599-1] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/07/2022] [Accepted: 06/10/2022] [Indexed: 12/09/2022]
Abstract
Iron deficiency anemia affects approximately 45% of patients with inflammatory bowel disease (IBD), negatively impacts the quality of life in this patient population, and significantly burdens our healthcare system. The pathogenesis of iron deficiency in IBD patients is multifactorial, including intestinal bleeding, malabsorption, and inadequate oral intake. Regular screening and diagnosis in these patients are imperative, and often patients have mixed iron deficiency anemia and anemia of chronic disease, especially in those with active inflammation. Iron may be replenished either orally or intravenously. While oral iron is safe, affordable, and easy to administer, patients often suffer from intolerable gastrointestinal side effects, and particularly in IBD patients, oral iron may increase inflammation and contribute to flares. Therefore, although it is substantially underused, intravenous (IV) iron is considered first-line treatment for patients with active disease, severe anemia, oral iron intolerance, and erythropoietin requirements. Several IV iron formulations are available, and iron sucrose and ferric carboxymaltose are the most frequently used and well studied in patients with IBD. However, iron isomaltoside could potentially become a popular choice among providers given its safety, efficacy, and convenience. Overall, screening, diagnosis, and treatment of iron deficiency anemia are important in patients with IBD. Individual patient characteristics, risks, and benefits, and advantages and disadvantages, should be considered when determining the best route and formulation for iron repletion.
Collapse
|
28
|
Liu LM, Wu DP. [Application progress of high-dose intravenous iron in the treatment of iron deficiency anemia]. ZHONGHUA XUE YE XUE ZA ZHI = ZHONGHUA XUEYEXUE ZAZHI 2022; 43:960-963. [PMID: 36709190 PMCID: PMC9808871 DOI: 10.3760/cma.j.issn.0253-2727.2022.11.014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Subscribe] [Scholar Register] [Received: 05/15/2022] [Indexed: 01/30/2023]
Affiliation(s)
- L M Liu
- National Clinical Research Center for Hematologic Diseases, the First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology, Key Laboratory of Thrombosis and Hemostasis of Ministry of Health, Suzhou 215006, China
| | - D P Wu
- National Clinical Research Center for Hematologic Diseases, the First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology, Key Laboratory of Thrombosis and Hemostasis of Ministry of Health, Suzhou 215006, China
| |
Collapse
|
29
|
Taladrid D, Zorraquín‐Peña I, Molinero N, Silva M, Manceñido N, Pajares R, Bartolomé B, Moreno‐Arribas MV. Polyphenols and Ulcerative Colitis: An Exploratory Study of the Effects of Red Wine Consumption on Gut and Oral Microbiome in Active-Phase Patients. Mol Nutr Food Res 2022; 66:e2101073. [PMID: 35633101 PMCID: PMC9787944 DOI: 10.1002/mnfr.202101073] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/27/2021] [Revised: 05/09/2022] [Indexed: 12/30/2022]
Abstract
SCOPE This paper explores the effects of moderate red wine consumption on the clinical status and symptomatology of patients with ulcerative colitis (UC), including the study of the oral and intestinal microbiome. METHODS AND RESULTS A case control intervention study in UC patients is designed. Intervention patients (n = 5) consume red wine (250 mL day-1 ) for 4 weeks whereas control patients (n = 5) do not. Moderate wine consumption significantly (p < 0.05) improves some clinical parameters related to serum iron, and alleviates intestinal symptoms as evaluated by the IBDQ-32 questionnaire. 16S rRNA gene sequencing indicate a non-significant (p > 0.05) increase in bacterial alpha diversity after wine intervention in both saliva and fecal microbiota. Additional comparison of taxonomic data between UC patients (n = 10) and healthy subjects (n = 8) confirm intestinal dysbiosis for the UC patients. Finally, analysis of fecal metabolites (i.e., phenolic acids and SCFAs) indicates a non-significant increase (p > 0.05) for the UC patients that consumed wine. CONCLUSIONS Moderate and regular red wine intake seems to improve the clinical status and symptoms of UC patients in the active phase of the disease. However, studies with a greater sample size are required to achieve conclusive results.
Collapse
Affiliation(s)
- Diego Taladrid
- Institute of Food Science Research (CIAL)CSIC‐UAM, c/Nicolás Cabrera 9Madrid28049Spain
| | - Irene Zorraquín‐Peña
- Institute of Food Science Research (CIAL)CSIC‐UAM, c/Nicolás Cabrera 9Madrid28049Spain
| | - Natalia Molinero
- Institute of Food Science Research (CIAL)CSIC‐UAM, c/Nicolás Cabrera 9Madrid28049Spain
| | - Mariana Silva
- Institute of Food Science Research (CIAL)CSIC‐UAM, c/Nicolás Cabrera 9Madrid28049Spain
| | - Noemi Manceñido
- Hospital Universitario “Infanta Sofia”, P.° de Europa34, 28703 San Sebastián de los ReyesMadridSpain
| | - Ramón Pajares
- Hospital Universitario “Infanta Sofia”, P.° de Europa34, 28703 San Sebastián de los ReyesMadridSpain
| | - Begoña Bartolomé
- Institute of Food Science Research (CIAL)CSIC‐UAM, c/Nicolás Cabrera 9Madrid28049Spain
| | | |
Collapse
|
30
|
Boots JMM, Quax RAM. High-Dose Intravenous Iron with Either Ferric Carboxymaltose or Ferric Derisomaltose: A Benefit-Risk Assessment. Drug Saf 2022; 45:1019-1036. [PMID: 36068430 PMCID: PMC9492608 DOI: 10.1007/s40264-022-01216-w] [Citation(s) in RCA: 7] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 07/19/2022] [Indexed: 11/22/2022]
Abstract
The intravenous iron formulations ferric carboxymaltose (FCM) and ferric derisomaltose (FDI) offer the possibility of administering a large amount of iron in one infusion. This results in faster correction of anemia and the formulations being better tolerated than oral iron formulations. This triad of logistic advantages, improved patient convenience, and fast correction of anemia explains the fact that intravenous iron formulations nowadays are frequently prescribed worldwide in the treatment of iron deficiency anemia. However, these formulations may result in hypophosphatemia by inducing a strong increase in active fibroblast growth factor-23 (FGF-23), a hormone that stimulates renal phosphate excretion. This effect is much more pronounced with FCM than with FDI, and therefore the risk of developing hypophosphatemia is remarkably higher with FCM than with FDI. Repeated use of FCM may result in severe osteomalacia, which is characterized by bone pain, Looser zones (pseudofractures), and low-trauma fractures. Intravenous iron preparations are also associated with other adverse effects, of which hypersensitivity reactions are the most important and are usually the result of a non-allergic complement activation on nanoparticles of free labile iron-Complement Activation-Related Pseudo-Allergy (CARPA). The risk on these hypersensitivity reactions can be reduced by choosing a slow infusion rate. Severe hypersensitivity reactions were reported in < 1% of prospective trials and the incidence seems comparable between the two formulations. A practical guideline has been developed based on baseline serum phosphate concentrations and predisposing risk factors, derived from published cases and risk factor analyses from trials, in order to establish the safe use of these formulations.
Collapse
Affiliation(s)
- Johannes M M Boots
- Department of Internal Medicine, Maasstad Hospital, Maasstadweg 21, 3079 DZ, Rotterdam, The Netherlands.
| | - Rogier A M Quax
- Department of Internal Medicine, Maasstad Hospital, Maasstadweg 21, 3079 DZ, Rotterdam, The Netherlands
| |
Collapse
|
31
|
Ortiz-Serrano R, Leal-Bernal J, López-Acevedo AV, Martínez-Maldonado EG, Mejía-Rodríguez PA. Beneficios del uso del hierro parenteral como alternativa eficaz en el manejo de la anemia gestacional en Colombia. MEDUNAB 2022. [DOI: 10.29375/01237047.3966] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
Abstract
Introducción. La Organización Mundial de la Salud (OMS) estima que más del 40% de las mujeres embarazadas a nivel mundial tienen anemia, y la mitad de estas padecen deficiencia de hierro. La prevalencia en América Latina es del 40% y en Colombia del 44.7%. Fisiológicamente en el embarazo se produce una mal llamada “anemia dilucional”, existen condiciones en la embarazada que la predisponen a tener una anemia patológica. Esta última es causada principalmente por un déficit de hierro, de allí la importancia de diagnosticar a tiempo esta entidad e iniciar el manejo. La administración de hierro es la base del tratamiento de la anemia por deficiencia de hierro. Puede ser administrado por vía oral, la cual es la preferida en la mayoría de las pacientes; sin embargo, cuando este no es posible administrarlo, es esencial recurrir al hierro parenteral. No obstante, el hierro parenteral es poco usado como primera línea en el manejo de la anemia gestacional. El presente artículo tiene como objetivo realizar una revisión que permita identificar la terapia con hierro parenteral como una alternativa eficaz de manejo para la anemia gestacional, teniendo en cuenta las características farmacológicas, la administración y el uso entre las diferentes moléculas disponibles en Colombia. Metodología. Corresponde a un estudio de revisión de literatura en bases de datos y bibliotecas electrónicas, los criterios que se tuvieron en cuenta fueron textos publicados entre 1996 y 2020, en español e inglés. Se obtuvo un resultado de 95 artículos, de los cuales se seleccionaron 49. Las palabras clave para su búsqueda fueron fisiología, hierro parenteral, anemia gestacional, déficit de hierro, complicaciones del embarazo, compuestos de hierro, farmacocinética, diagnóstico y tratamiento. División de temas tratados. Fisiología; ayudas diagnósticas; características farmacológicas del hierro parenteral; ventajas, indicaciones y contraindicaciones del hierro parenteral; efectos secundarios y forma de aplicación. Conclusiones. El hierro parenteral es un tratamiento seguro y eficaz para manejar la anemia en el embarazo, se debe tener en cuenta las indicaciones y la farmacología de las moléculas para elegir la más adecuada. Además, repone más rápidamente las reservas de hierro y los niveles de hemoglobina.
Collapse
|
32
|
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] [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.
Collapse
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
- *Correspondence: Miguel Montoro,
| | | | - 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
| |
Collapse
|
33
|
Bergamaschi G, Caprioli F, Lenti MV, Elli L, Radaelli F, Rondonotti E, Mengoli C, Miceli E, Ricci C, Ardizzone S, Vecchi M, Di Sabatino A. Pathophysiology and therapeutic management of anemia in gastrointestinal disorders. Expert Rev Gastroenterol Hepatol 2022; 16:625-637. [PMID: 35696485 DOI: 10.1080/17474124.2022.2089114] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/04/2022]
Abstract
INTRODUCTION Anemia is a common complication of gastrointestinal (GI) disorders, with a prevalence up to 60% in celiac disease (CeD) and inflammatory bowel disease (IBD). Iron deficiency anemia (IDA) is the most prevalent form of anemia in these conditions, but chronic inflammation and vitamin B12 deficiency represent other common contributing mechanisms, especially in IBD. AREAS COVERED We discuss the pathogenesis of anemia in various medical GI disorders, the sometime problematic distinction between IDA, anemia of inflammation (AI) and the association of the two, and therapeutic and preventive measures that can be useful for the management of anemia in GI disorders. Unfortunately, with the exception of IDA and AI in IBD, large RCT concerning the treatment of anemia in GI disorders are lacking. EXPERT OPINION Anemia management strategies in GI disorders are outlined, with a focus on the main prevention, diagnostic, and therapeutic measures. Specific problems and situations such as the role of gluten-free diet for IDA treatment in CeD, the choice between oral and parenteral supplementation of iron or vitamin B12 in carential anemias, the use of endoscopic procedures to stop bleeding in intestinal angiodysplasia and preventive/treatment strategies for NSAID-associated GI bleeding are discussed.
Collapse
Affiliation(s)
- Gaetano Bergamaschi
- Department of Internal Medicine, San Matteo Hospital Foundation, Pavia, Italy
| | - Flavio Caprioli
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico and Università degli Studi di Milano, Milan, Italy
| | - Marco Vincenzo Lenti
- Department of Internal Medicine, San Matteo Hospital Foundation, Pavia, Italy.,Department of Internal Medicine, University of Pavia, Pavia, Italy
| | - Luca Elli
- Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milan, Milan, Italy
| | | | | | - Caterina Mengoli
- Department of Internal Medicine, San Matteo Hospital Foundation, Pavia, Italy
| | - Emanuela Miceli
- Department of Internal Medicine, San Matteo Hospital Foundation, Pavia, Italy
| | - Chiara Ricci
- Gastroenterology Unit, Spedali Civili di Brescia and Department of Clinical and Experimental Sciences, University of Brescia, Brescia Italy
| | - Sandro Ardizzone
- Sacco, University of MilanGastroenterology and Digestive Endoscopy Unit, Department of Biochemical and Clinical Sciences L , Milano, Italy
| | - Maurizio Vecchi
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico and Università degli Studi di Milano, Milan, Italy
| | - Antonio Di Sabatino
- Department of Internal Medicine, San Matteo Hospital Foundation, Pavia, Italy.,Department of Internal Medicine, University of Pavia, Pavia, Italy
| |
Collapse
|
34
|
Grova M, Crispino F, Maida M, Renna S, Mannino M, Casà A, Rizzuto G, Macaluso FS, Orlando A. Effectiveness and safety of an on-demand ferric carboxymaltose infusion strategy in patients with inflammatory bowel disease: a real world experience. Eur J Gastroenterol Hepatol 2022; 34:607-612. [PMID: 35102111 DOI: 10.1097/meg.0000000000002348] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/10/2022]
Abstract
BACKGROUND We evaluated an on-demand ferric carboxymaltose (FCM) infusion strategy in inflammatory bowel disease (IBD) patients with iron deficiency anemia (IDA). AIMS The primary outcome was the response rate to single or multiple FCM infusions after 12 months. Secondary outcomes were the response rate to a single FCM infusion after 3 months and the FCM safety profile. METHODS We retrospectively included 185 IBD patients who received at least one FCM infusion of 500 mg, between 2015 and 2018. FCM was administered to patients with Hb ≤10 g/dL and hypoferritinemia and repeated according to the physician's assessment. Complete response (CR) was defined as Hb ≥12 g/dL (≥13 g/dL for men) or Hb increase ≥2 g/dL. Partial response (PR) was defined as an Hb increase between 1 and 2 g/dL. A univariate analysis was performed at 3 and 12 months. RESULTS After 12 months, the response rate was 75.1% (CR, 48.6%; PR, 26.4%; mean number of FCM infusions, 1.7 ± 1.1). In total 169/185 patients received a single FCM infusion during the first 3 months and 79.2% achieved response (CR, 56.8%; PR, 22.4%). At univariate analysis, no variable was associated with response. No adverse events were reported. CONCLUSIONS An on-demand strategy was effective and well-tolerated in treating IDA in IBD patients.
Collapse
Affiliation(s)
- Mauro Grova
- Department of Health Promotion Sciences Maternal and Infant Care, Section of Gastroenterology and Hepatology, Internal Medicine and Medical Specialties, PROMISE, University of Palermo
- Department of Medicine, Inflammatory Bowel Disease Unit, A.O.O.R., "Villa Sofia-Cervello" Hospital, Palermo
| | - Federica Crispino
- Department of Health Promotion Sciences Maternal and Infant Care, Section of Gastroenterology and Hepatology, Internal Medicine and Medical Specialties, PROMISE, University of Palermo
- Department of Medicine, Inflammatory Bowel Disease Unit, A.O.O.R., "Villa Sofia-Cervello" Hospital, Palermo
| | - Marcello Maida
- Department of Gastroenterology and Digestive Endoscopy, Section of Gastroenterology, "S. Elia-Raimondi" Hospital, Caltanissetta, Italy
| | - Sara Renna
- Department of Medicine, Inflammatory Bowel Disease Unit, A.O.O.R., "Villa Sofia-Cervello" Hospital, Palermo
| | - Mariella Mannino
- Department of Medicine, Inflammatory Bowel Disease Unit, A.O.O.R., "Villa Sofia-Cervello" Hospital, Palermo
| | - Angelo Casà
- Department of Medicine, Inflammatory Bowel Disease Unit, A.O.O.R., "Villa Sofia-Cervello" Hospital, Palermo
| | - Giulia Rizzuto
- Department of Medicine, Inflammatory Bowel Disease Unit, A.O.O.R., "Villa Sofia-Cervello" Hospital, Palermo
| | - Fabio Salvatore Macaluso
- Department of Medicine, Inflammatory Bowel Disease Unit, A.O.O.R., "Villa Sofia-Cervello" Hospital, Palermo
| | - Ambrogio Orlando
- Department of Medicine, Inflammatory Bowel Disease Unit, A.O.O.R., "Villa Sofia-Cervello" Hospital, Palermo
| |
Collapse
|
35
|
Ferric Carboxymaltose Improves the Quality of Life of Patients with Inflammatory Bowel Disease and Iron Deficiency without Anaemia. J Clin Med 2022; 11:jcm11102786. [PMID: 35628914 PMCID: PMC9146412 DOI: 10.3390/jcm11102786] [Citation(s) in RCA: 6] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/21/2022] [Revised: 05/11/2022] [Accepted: 05/12/2022] [Indexed: 12/07/2022] Open
Abstract
Background: Iron deficiency (ID) without anaemia is a common comorbidity associated with inflammatory bowel disease (IBD) that has a negative impact on health-related quality of life (HRQoL). Methods: This multicentre, prospective, observational study examined the response to, safety of and impact on HRQoL of a single 500 mg dose of intravenous ferric carboxymaltose (FCM) in patients with IBD and ID without anaemia. The diagnostic criteria for ID were low serum ferritin (<30 µg/L in the absence of inflammatory activity or <100 µg/L with inflammation) and transferrin saturation index (TSAT) < 16%. The effect on iron levels and HRQoL, according to the health status questionnaires SF-12v2 and EQ-5D, was evaluated 1 month after FCM infusion in an outpatient setting. Results: Of the 105 patients who received FCM, 98 patients completed the study. After 1 month, a single dose of FCM significantly increased serum ferritin, serum iron and TSAT. Importantly, patients reported fewer ID symptoms and problems on all EQ-5D dimensions. They also had higher EQ-5D visual analogue scale and SF-12v2 scores after treatment. FCM had similar clinical effects on men and women and on patients with Crohn’s disease (n = 66) and ulcerative colitis (n = 32). Conclusion: A single dose of FCM rapidly restored iron parameters and significantly improved patients’ symptoms and HRQoL at 1 month after treatment.
Collapse
|
36
|
Argüelles-Arias F, Bermejo F, Borrás-Blasco J, Domènech E, Sicilia B, Huguet JM, de Arellano AR, Valentine WJ, Hunt B. Cost-effectiveness analysis of ferric carboxymaltose versus iron sucrose for the treatment of iron deficiency anemia in patients with inflammatory bowel disease in Spain. Therap Adv Gastroenterol 2022; 15:17562848221086131. [PMID: 35574429 PMCID: PMC9092579 DOI: 10.1177/17562848221086131] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/06/2021] [Accepted: 02/21/2022] [Indexed: 02/04/2023] Open
Abstract
BACKGROUND Iron deficiency anemia (IDA) is a common complication of inflammatory bowel disease (IBD) and can result in reduced quality of life and increased healthcare costs. IDA is treated with iron supplementation, commonly with intravenous iron formulations, such as ferric carboxymaltose (FCM), and iron sucrose (IS). METHODS This study assessed the cost-effectiveness of FCM compared with IS, in terms of additional cost per additional responder in patients with IDA subsequent to IBD in the Spanish setting. An economic model was developed to assess the additional cost per additional responder, defined as normalization or an increase of ⩾2 g/dl in hemoglobin levels, for FCM versus IS from a Spanish healthcare payer perspective. Efficacy inputs were taken from a randomized controlled trial comparing the two interventions (FERGIcor). Costs of treatment were calculated in 2021 Euros (EUR) using a microcosting approach and included the costs of intravenous iron, healthcare professional time, and consumables. Cost-effectiveness was assessed over one cycle of treatment, with a series of sensitivity analyses performed to test the robustness of the results. RESULTS FCM was more effective than IS, with 84% of patients achieving a response compared with 76%. When expressed as number needed to treat, 13 patients would need to switch treatment from IS to FCM in order to achieve one additional responder. Costs of treatment were EUR 323 with FCM compared with EUR 470 with IS, a cost saving of EUR 147 with FCM. Cost savings with FCM were driven by the reduced number of infusions required, resulting in a reduced requirement for healthcare professional time and use of consumables compared with the IS arm. CONCLUSION The present analysis suggests that FCM is less costly and more effective than IS for the treatment of IDA subsequent to IBD in Spain and therefore was considered dominant.
Collapse
Affiliation(s)
- Federico Argüelles-Arias
- Hospital Universitario Virgen Macarena,
Seville, Spain; Facultad de Medicina, Universidad de Sevilla, Seville,
Spain
| | - Fernando Bermejo
- Hospital Universitario de Fuenlabrada,
Instituto de Investigación Sanitaria del Hospital La Paz (IdiPAZ), Madrid,
Spain
| | | | - Eugeni Domènech
- Hospital Universitari Germans Trias i Pujol,
Badalona, Spain; CIBEREHD, Madrid, Spain
| | | | - José M. Huguet
- Hospital General Universitario de Valencia,
Valencia, Spain
| | | | | | | |
Collapse
|
37
|
Choi KY, Koh IJ, Kim MS, Kim C, In Y. Intravenous Ferric Carboxymaltose Improves Response to Postoperative Anemia Following Total Knee Arthroplasty: A Prospective Randomized Controlled Trial in Asian Cohort. J Clin Med 2022; 11:2357. [PMID: 35566482 PMCID: PMC9103711 DOI: 10.3390/jcm11092357] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/25/2022] [Revised: 04/18/2022] [Accepted: 04/20/2022] [Indexed: 12/04/2022] Open
Abstract
Background: Ferric carboxymaltose (FCM) is an intravenous (IV) high-dose iron that is effective in the treatment of iron deficiency anemia. This study was performed to determine whether postoperative FCM infusion is effective at improving hemoglobin (Hb) responders, Hb and iron profiles, and the patient’s quality of life (QOL). Methods: A total of 110 patients with postoperative anemia, defined by a Hb < 10 g/dL within 3 days of unilateral primary TKA, between June 2018 and February 2020 were randomized into either the FCM or Control group. On postoperative day 3, the FCM group (55 patients) received IV FCM while the Control group (55 patients) did not. The Hb responders (Hb increase ≥ 2 g/dL compared to baseline), Hb level, iron profiles (ferritin, total iron-binding capacity (TIBC), transferrin saturation (TSAT)), and EQ-5D scores were compared at weeks 2, 4, and 8. Results: The FCM group demonstrated a significantly greater number of Hb responders (p < 0.001) and a higher Hb level (p = 0.008) at 2 weeks postoperative than did the Control group. The FCM group recovered its preoperative Hb level between 4 and 8 weeks. In contrast, the Control group did not recover its preoperative level until 8 weeks. The FCM infusion group also had higher serum ferritin, iron and TSAT, and lower TIBC levels than those of the Control group between 2 and 8 weeks (all p < 0.001). However, there was no significant difference in the postoperative transfusion rate (p = 0.741) or EQ-5D score between the two groups (all p > 0.05). Discussion: In postoperative anemia following TKA, IV FCM increases the Hb response and improves Hb and iron metabolism variables, however, it does not affect the transfusion rate or QOL.
Collapse
Affiliation(s)
- Keun Young Choi
- Department of Orthopaedic Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea; (K.Y.C.); (M.S.K.); (C.K.)
| | - In Jun Koh
- Department of Orthopaedic Surgery, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul 03312, Korea;
| | - Man Soo Kim
- Department of Orthopaedic Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea; (K.Y.C.); (M.S.K.); (C.K.)
| | - Chulkyu Kim
- Department of Orthopaedic Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea; (K.Y.C.); (M.S.K.); (C.K.)
| | - Yong In
- Department of Orthopaedic Surgery, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea; (K.Y.C.); (M.S.K.); (C.K.)
| |
Collapse
|
38
|
Esposito G, Dottori L, Pivetta G, Ligato I, Dilaghi E, Lahner E. Pernicious Anemia: The Hematological Presentation of a Multifaceted Disorder Caused by Cobalamin Deficiency. Nutrients 2022; 14:nu14081672. [PMID: 35458234 PMCID: PMC9030741 DOI: 10.3390/nu14081672] [Citation(s) in RCA: 24] [Impact Index Per Article: 8.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/08/2022] [Revised: 04/08/2022] [Accepted: 04/14/2022] [Indexed: 02/04/2023] Open
Abstract
Pernicious anemia is still a neglected disorder in many medical contexts and is underdiagnosed in many patients. Pernicious anemia is linked to but different from autoimmune gastritis. Pernicious anemia occurs in a later stage of autoimmune atrophic gastritis when gastric intrinsic factor deficiency and consequent vitamin B12 deficiency may occur. The multifaceted nature of pernicious anemia is related to the important role of cobalamin, which, when deficient, may lead to several dysfunctions, and thus, the proteiform clinical presentations of pernicious anemia. Indeed, pernicious anemia may lead to potentially serious long-term complications related to micronutrient deficiencies and their consequences and the development of gastric cancer and type 1 gastric neuroendocrine tumors. When not recognized in a timely manner or when pernicious anemia is diagnosed with delay, these complications may be potentially life-threatening and sometimes irreversible. The current review aimed to focus on epidemiology, pathogenesis, and clinical presentations of pernicious anemia in an attempt to look beyond borders of medical specialties. It aimed to focus on micronutrient deficiencies besides the well-known vitamin B12 deficiency, the diagnostic approach for pernicious anemia, its long-term complications and optimal clinical management, and endoscopic surveillance of patients with pernicious anemia.
Collapse
|
39
|
Sturm A, Atreya R, Bettenworth D, Bokemeyer B, Dignaß A, Ehehalt R, Germer C, Grunert PC, Helwig U, Herrlinger K, Kienle P, Kreis ME, Kucharzik T, Langhorst J, Maaser C, Ockenga J, Ott C, Siegmund B, Zeißig S, Stallmach A. Aktualisierte S3-Leitlinie „Diagnostik und Therapie des Morbus Crohn“ der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) – August 2021 – AWMF-Registernummer: 021-004. ZEITSCHRIFT FUR GASTROENTEROLOGIE 2022; 60:332-418. [PMID: 35263784 DOI: 10.1055/a-1713-3941] [Citation(s) in RCA: 29] [Impact Index Per Article: 9.7] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Affiliation(s)
- Andreas Sturm
- Klinik für Innere Medizin mit Schwerpunkt Gastroenterologie, DRK Kliniken Berlin Westend, Berlin, Deutschland
| | - Raja Atreya
- Medizinische Klinik 1, Universitätsklinikum Erlangen, Deutschland
| | | | - Bernd Bokemeyer
- Gastroenterologische Gemeinschaftspraxis Minden, Deutschland
| | - Axel Dignaß
- Medizinische Klinik I, Agaplesion Markus Krankenhaus, Frankfurt am Main, Deutschland
| | | | - Christoph Germer
- Chirurgische Klinik I, Universitätsklinikum Würzburg, Deutschland
| | - Philip C Grunert
- Klinik für Innere Medizin IV (Gastroenterologie, Hepatologie und Infektiologie), Universitätsklinikum Jena, Deutschland
| | - Ulf Helwig
- Internistische Praxengemeinschaft, Oldenburg, Deutschland
| | | | - Peter Kienle
- Allgemein- und Viszeralchirurgie, Theresienkrankenhaus und Sankt Hedwig-Klinik GmbH, Mannheim, Deutschland
| | - Martin E Kreis
- Klinik für Allgemein-, Viszeral- und Gefäßchirurgie, Charité Campus Benjamin Franklin - Universitätsmedizin Berlin, Deutschland
| | - Torsten Kucharzik
- Klinik für Allgemeine Innere Medizin und Gastroenterologie, Klinikum Lüneburg, Deutschland
| | - Jost Langhorst
- Klinik für Integrative Medizin und Naturheilkunde, Klinikum am Bruderwald, Bamberg, Deutschland
| | | | - Johann Ockenga
- Medizinische Klinik II, Klinikum Bremen Mitte - Gesundheit Nord, Bremen, Deutschland
| | - Claudia Ott
- Gastroenterologie Facharztzentrum, Regensburg, Deutschland
| | - Britta Siegmund
- Medizinische Klinik I, Charité Universitätsmedizin Berlin, Campus Benjamin Franklin, Deutschland
| | - Sebastian Zeißig
- Medizinische Klinik und Poliklinik I, Universitätsklinikum Dresden, Deutschland
| | - Andreas Stallmach
- Klinik für Innere Medizin IV (Gastroenterologie, Hepatologie und Infektiologie), Universitätsklinikum Jena, Deutschland
| | | |
Collapse
|
40
|
Howaldt S, Domènech E, Martinez N, Schmidt C, Bokemeyer B. Long-Term Effectiveness of Oral Ferric Maltol vs Intravenous Ferric Carboxymaltose for the Treatment of Iron-Deficiency Anemia in Patients With Inflammatory Bowel Disease: A Randomized Controlled Noninferiority Trial. Inflamm Bowel Dis 2022; 28:373-384. [PMID: 33988236 PMCID: PMC8889281 DOI: 10.1093/ibd/izab073] [Citation(s) in RCA: 11] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/17/2020] [Indexed: 12/18/2022]
Abstract
BACKGROUND Iron-deficiency anemia is common in inflammatory bowel disease, requiring oral or intravenous iron replacement therapy. Treatment with standard oral irons is limited by poor absorption and gastrointestinal toxicity. Ferric maltol is an oral iron designed for improved absorption and tolerability. METHODS In this open-label, phase 3b trial (EudraCT 2015-002496-26 and NCT02680756), adults with nonseverely active inflammatory bowel disease and iron-deficiency anemia (hemoglobin, 8.0-11.0/12.0 g/dL [women/men]; ferritin, <30 ng/mL/<100 ng/mL with transferrin saturation <20%) were randomized to oral ferric maltol 30 mg twice daily or intravenous ferric carboxymaltose given according to each center's standard practice. The primary endpoint was a hemoglobin responder rate (≥2 g/dL increase or normalization) at week 12, with a 20% noninferiority limit in the intent-to-treat and per-protocol populations. RESULTS For the intent-to-treat (ferric maltol, n = 125/ferric carboxymaltose, n = 125) and per-protocol (n = 78/88) analyses, week 12 responder rates were 67% and 68%, respectively, for ferric maltol vs 84% and 85%, respectively, for ferric carboxymaltose. As the confidence intervals crossed the noninferiority margin, the primary endpoint was not met. Mean hemoglobin increases at weeks 12, 24, and 52 were 2.5 vs 3.0 g/dL, 2.9 vs 2.8 g/dL, and 2.7 vs 2.8 g/dL with ferric maltol vs ferric carboxymaltose. Treatment-emergent adverse events occurred in 59% and 36% of patients, respectively, and resulted in treatment discontinuation in 10% and 3% of patients, respectively. CONCLUSIONS Ferric maltol achieved clinically relevant increases in hemoglobin but did not show noninferiority vs ferric carboxymaltose at week 12. Both treatments had comparable long-term effectiveness for hemoglobin and ferritin over 52 weeks and were well tolerated.
Collapse
Affiliation(s)
| | - Eugeni Domènech
- Gastroenterology and Hepatology Department, Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, and Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas, Madrid, Spain
| | | | - Carsten Schmidt
- Department of Gastroenterology, Hepatology, Endocrinology, Diabetology, and Infectious Diseases, Klinikum Fulda, Fulda, Germany
| | - Bernd Bokemeyer
- Gastroenterology Practice Minden and University Hospital Schleswig-Holstein, Campus Kiel, Clinic for Internal Medicine I, Kiel, Germany
| |
Collapse
|
41
|
Abstract
INTRODUCTION the ESPEN guideline offers a multidisciplinary focus on clinical nutrition in inflammatory bowel disease (IBD). METHODOLOGY the guideline is based on a extensive systematic review of the literature, but relies on expert opinion when objective data are lacking or inconclusive. The conclusions and 64 recommendations have been subject to full peer review and a Delphi process, in which uniformly positive responses (agree or strongly agree) were required. RESULTS IBD is increasingly common and potential dietary factors in its etiology are briefly reviewed. Malnutrition is highly prevalent in IBD - especially in Crohn's disease. Increased energy and protein requirements are observed in some patients. The management of malnutrition in IBD is considered within the general context of support for malnourished patients. Treatment of iron deficiency (parenterally, if necessary) is strongly recommended. Routine provision of a special diet in IBD is not, however, supported. Parenteral nutrition is indicated only when enteral nutrition has failed or is impossible. The recommended perioperative management of patients with IBD undergoing surgery accords with general ESPEN guidance for patients having abdominal surgery. Probiotics may be helpful in UC but not in Crohn's disease. Primary therapy using nutrition to treat IBD is not supported in ulcerative colitis but is moderately well supported in Crohn's disease, especially in children, where the adverse consequences of steroid therapy are proportionally greater. However, exclusion diets are generally not recommended and there is little evidence to support any particular formula feed when nutritional regimens are constructed. CONCLUSIONS available objective data to guide nutritional support and primary nutritional therapy in IBD are presented as 64 recommendations, of which 9 are very strong recommendations (grade A), 22 are strong recommendations (grade B), and 12 are based only on sparse evidence (grade 0); 21 recommendations are good practice points (GPP).
Collapse
|
42
|
Kumar A, Sharma E, Marley A, Samaan MA, Brookes MJ. Iron deficiency anaemia: pathophysiology, assessment, practical management. BMJ Open Gastroenterol 2022; 9:e000759. [PMID: 34996762 PMCID: PMC8744124 DOI: 10.1136/bmjgast-2021-000759] [Citation(s) in RCA: 76] [Impact Index Per Article: 25.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/16/2021] [Accepted: 12/20/2021] [Indexed: 02/07/2023] Open
Abstract
The WHO has recognised iron deficiency anaemia (IDA) as the most common nutritional deficiency in the world, with 30% of the population being affected with this condition. Although the most common causes of IDA are gastrointestinal bleeding and menstruation in women, decreased dietary iron and decreased iron absorption are also culpable causes. Patients with IDA should be treated with the aim of replenishing iron stores and returning the haemoglobin to a normal level. This has shown to improve quality of life, morbidity, prognosis in chronic disease and outcomes in pregnancy. Iron deficiency occurs in many chronic inflammatory conditions, including congestive cardiac failure, chronic kidney disease and inflammatory bowel disease. This article will provide an updated overview on diagnosis and management of IDA in patients with chronic conditions, preoperative and in pregnancy. We will discuss the benefits and limitations of oral versus intravenous iron replacement in each cohort, with an overview on cost analysis between the different iron formulations currently on the market.
Collapse
Affiliation(s)
- Aditi Kumar
- Department of Gastroenterology, The Royal Wolverhampton NHS Trust, Wolverhampton, UK
| | - Esha Sharma
- Inflammatory Bowel Disease Unit, Guys and St Thomas' NHS Foundation Trust, London, UK
| | - Alexandra Marley
- Department of Gastroenterology, The Royal Wolverhampton NHS Trust, Wolverhampton, UK
| | - Mark A Samaan
- Inflammatory Bowel Disease Unit, Guys and St Thomas' NHS Foundation Trust, London, UK
| | - Matthew James Brookes
- Department of Gastroenterology, The Royal Wolverhampton NHS Trust, Wolverhampton, UK
- Research Institue, Faculty of Science and Engineering, University of Wolverhampton, Wolverhampton, UK
| |
Collapse
|
43
|
Muñoz M, Reinisch W. Letter to the Editor Regarding 'Iron Formulations for the Treatment of Iron Deficiency Anemia in Patients with Inflammatory Bowel Disease: A Cost-Effectiveness Analysis in Switzerland'. Adv Ther 2022; 39:811-814. [PMID: 34846707 PMCID: PMC8799545 DOI: 10.1007/s12325-021-02000-5] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/18/2021] [Accepted: 11/16/2021] [Indexed: 12/15/2022]
|
44
|
Aksan A, Schoepfer A, Juillerat P, Vavricka S, Bettencourt M, Ramirez de Arellano A, Gavata S, Morin N, Valentine WJ, Hunt B. A Response to: Letter to the Editor Regarding 'Iron Formulations for the Treatment of Iron Deficiency Anemia in Patients with Inflammatory Bowel Disease: A Cost-Effectiveness Analysis in Switzerland'. Adv Ther 2022; 39:815-821. [PMID: 34846708 PMCID: PMC8799560 DOI: 10.1007/s12325-021-02001-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/10/2021] [Accepted: 11/16/2021] [Indexed: 11/24/2022]
Affiliation(s)
- Aysegül Aksan
- Interdisciplinary Crohn Colitis Centre, Rhein-Main, Frankfurt am Main, Germany
- Justus-Liebig University, Giessen, Germany
| | - Alain Schoepfer
- Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire de Lausanne and University of Lausanne, Lausanne, Switzerland
| | - Pascal Juillerat
- Gastroenterology, Clinic of Visceral Surgery and Medicine, Bern University Hospital, Bern, Switzerland
| | - Stephan Vavricka
- Zentrum für Gastroenterologie und Hepatologie, Zürich, Switzerland
| | | | | | - Simona Gavata
- Vifor Pharma Group, Flughofstrasse 61, 8152, Glattbrugg, Switzerland
| | - Neige Morin
- Vifor Pharma Group, Villars-sur-Glâne, Switzerland
| | | | - Barnaby Hunt
- Ossian Health Economics and Communications, Basel, Switzerland
| |
Collapse
|
45
|
Makharadze T, Boccia R, Krupa A, Blackman N, Henry DH, Gilreath JA. Efficacy and safety of ferric carboxymaltose infusion in reducing anemia in patients receiving chemotherapy for nonmyeloid malignancies: A randomized, placebo-controlled study (IRON-CLAD). Am J Hematol 2021; 96:1639-1646. [PMID: 34653287 PMCID: PMC9298873 DOI: 10.1002/ajh.26376] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/09/2021] [Revised: 09/30/2021] [Accepted: 10/04/2021] [Indexed: 12/03/2022]
Abstract
Erythropoiesis‐stimulating agents (ESA) are effective for chemotherapy‐induced anemia (CIA) but associated with serious adverse events. Safer alternatives would be beneficial in this population. The efficacy and safety of ferric carboxymaltose (FCM) as monotherapy for CIA was evaluated. This Phase 3, 18‐week, double‐blind, placebo‐controlled study randomized adults with ≥ 4 weeks of chemotherapy remaining for treatment of nonmyeloid malignancies with CIA to FCM (two 15 mg/kg infusions 7 days apart; maximum dose, 750 mg single/1500 mg total) or placebo. The primary efficacy endpoint was percentage of patients with decreases in hemoglobin (Hb) ≥ 0.5 g/dL from weeks 3 to 18; the key secondary efficacy endpoint was change in Hb from baseline to week 18. Inclusion criteria included: (Hb) 8–11 g/dL, ferritin 100–800 ng/mL, and transferrin saturation (TSAT) ≤35%. In 244 patients (n = 122, both groups), the percent of patients who maintained Hb within 0.5 g/dL of baseline from weeks 3 to 18 was significantly higher with FCM versus placebo (50.8% vs. 35.3%; p = 0.01). Mean change in Hb from baseline to week 18 was similar between FCM and placebo (1.04 vs. 0.87 g/dL) but significantly greater with FCM with baseline Hb ≤ 9.9 g/dL (1.08 vs. 0.42 g/dL; p = 0.01). The percent with ≥ 1 g/dL increase from baseline was significantly higher with FCM versus placebo (71% vs. 54%; p = 0.01), occurring in a median 43 versus 85 days (p = 0.001). Common adverse events in the FCM arm included neutropenia (17%), hypophosphatemia (16%), and fatigue (15%). FCM monotherapy effectively maintained Hb and was well tolerated in CIA.
Collapse
Affiliation(s)
| | - Ralph Boccia
- Center for Cancer and Blood Disorders Bethesda Maryland USA
| | - Anna Krupa
- College of Pharmacy and Health Sciences St. John's University Queens New York USA
| | | | - David H. Henry
- Abramson Cancer Center Pennsylvania Hospital Philadelphia Pennsylvania USA
| | | |
Collapse
|
46
|
Łodyga M, Eder P, Gawron-Kiszka M, Dobrowolska A, Gonciarz M, Hartleb M, Kłopocka M, Małecka-Wojciesko E, Radwan P, Reguła J, Zagórowicz E, Rydzewska G. Guidelines for the management of patients with Crohn's disease. Recommendations of the Polish Society of Gastroenterology and the Polish National Consultant in Gastroenterology. PRZEGLAD GASTROENTEROLOGICZNY 2021; 16:257-296. [PMID: 34976235 PMCID: PMC8690943 DOI: 10.5114/pg.2021.110914] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Received: 10/01/2021] [Accepted: 10/25/2021] [Indexed: 12/13/2022]
Abstract
This paper is an update of the diagnostic and therapeutic recommendations of the National Consultant for Gastroenterology and the Polish Society of Gastroenterology from 2012. It contains 46 recommendations for the diagnosis and treatment, both pharmacological and surgical, of Crohn's disease in adults. The guidelines were developed by a group of experts appointed by the Polish Society of Gastroenterology and the National Consultant in the field of Gastroenterology. The methodology related to the GRADE methodology was used to assess the quality and strength of the available recommendations. The degree of expert support for the proposed statement, assessment of the quality of evidence and the strength of the recommendation was assessed on a 6-point Likert scale. Voting results, quality and strength ratings with comments are included with each statement.
Collapse
Affiliation(s)
- Michał Łodyga
- Department of Gastroenterology with the Inflammatory Bowel Disease Subdivision, Central Clinical Hospital of the Ministry of the Interior and Administration, Warsaw, Poland
| | - Piotr Eder
- Department of Gastroenterology, Dietetics and Internal Medicine, Poznan University of Medical Sciences, Heliodor Święcicki University Hospital, Poznan, Poland
| | - Magdalena Gawron-Kiszka
- Department of Gastroenterology and Hepatology, Medical University of Silesia, Katowice, Poland
| | - Agnieszka Dobrowolska
- Department of Gastroenterology, Dietetics and Internal Medicine, Poznan University of Medical Sciences, Heliodor Święcicki University Hospital, Poznan, Poland
| | - Maciej Gonciarz
- Department of Gastroenterology and Internal Medicine, Military Institute of Medicine, Warsaw, Poland
| | - Marek Hartleb
- Department of Gastroenterology and Hepatology, Medical University of Silesia, Katowice, Poland
| | - Maria Kłopocka
- Department of Gastroenterology and Nutritional Disorders, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Poland
| | | | - Piotr Radwan
- Department of Gastroenterology, Medical University of Lublin, Lublin, Poland
| | - Jarosław Reguła
- Department of Gastroenterology, Hepatology and Clinical Oncology, Center of Postgraduate Medical Education, Warsaw, Poland
- Department of Oncological Gastroenterology, Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland
| | - Edyta Zagórowicz
- Department of Gastroenterology, Hepatology and Clinical Oncology, Center of Postgraduate Medical Education, Warsaw, Poland
- Department of Oncological Gastroenterology, Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland
| | - Grażyna Rydzewska
- Department of Gastroenterology with the Inflammatory Bowel Disease Subdivision, Central Clinical Hospital of the Ministry of the Interior and Administration, Warsaw, Poland
- Collegium Medicum, Jan Kochanowski University, Kielce, Poland
| |
Collapse
|
47
|
Snook J, Bhala N, Beales ILP, Cannings D, Kightley C, Logan RP, Pritchard DM, Sidhu R, Surgenor S, Thomas W, Verma AM, Goddard AF. British Society of Gastroenterology guidelines for the management of iron deficiency anaemia in adults. Gut 2021; 70:2030-2051. [PMID: 34497146 PMCID: PMC8515119 DOI: 10.1136/gutjnl-2021-325210] [Citation(s) in RCA: 137] [Impact Index Per Article: 34.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/19/2021] [Accepted: 07/26/2021] [Indexed: 12/12/2022]
Abstract
Iron deficiency anaemia (IDA) is a major cause of morbidity and burden of disease worldwide. It can generally be diagnosed by blood testing and remedied by iron replacement therapy (IRT) using the oral or intravenous route. The many causes of iron deficiency include poor dietary intake and malabsorption of dietary iron, as well as a number of significant gastrointestinal (GI) pathologies. Because blood is iron-rich it can result from chronic blood loss, and this is a common mechanism underlying the development of IDA-for example, as a consequence of menstrual or GI blood loss.Approximately a third of men and postmenopausal women presenting with IDA have an underlying pathological abnormality, most commonly in the GI tract. Therefore optimal management of IDA requires IRT in combination with appropriate investigation to establish the underlying cause. Unexplained IDA in all at-risk individuals is an accepted indication for fast-track secondary care referral in the UK because GI malignancies can present in this way, often in the absence of specific symptoms. Bidirectional GI endoscopy is the standard diagnostic approach to examination of the upper and lower GI tract, though radiological scanning is an alternative in some situations for assessing the large bowel. In recurrent or refractory IDA, wireless capsule endoscopy plays an important role in assessment of the small bowel.IDA may present in primary care or across a range of specialties in secondary care, and because of this and the insidious nature of the condition it has not always been optimally managed despite the considerable burden of disease- with investigation sometimes being inappropriate, incorrectly timed or incomplete, and the role of IRT for symptom relief neglected. It is therefore important that contemporary guidelines for the management of IDA are available to all clinicians. This document is a revision of previous British Society of Gastroenterology guidelines, updated in the light of subsequent evidence and developments.
Collapse
Affiliation(s)
- Jonathon Snook
- Gastroenterology, University Hospitals Dorset NHS Foundation Trust, Poole, UK
| | - Neeraj Bhala
- Gastroenterology, Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust and Institute of Applied Health Research, University of Birmingham, Birmingham, UK
| | - Ian L P Beales
- Gastroenterology, University of East Anglia, Norwich, UK
| | - David Cannings
- Gastroenterology, University Hospitals Dorset NHS Foundation Trust, Poole, UK
| | - Chris Kightley
- Digestive Diseases, Kettering General Hospital NHS Foundation Trust, Kettering, UK
| | | | - D Mark Pritchard
- Institute of Systems, Molecular and Integrative Biology, University of Liverpool and Department of Gastroenterology, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK
| | - Reena Sidhu
- Gastroenterology, Royal Hallamshire Hospital, Sheffield, UK
| | - Sue Surgenor
- Gastroenterology, University Hospitals Dorset NHS Foundation Trust, Poole, UK
| | - Wayne Thomas
- Haematology, Plymouth Hospitals NHS Foundation Trust, Plymouth, Plymouth, UK
| | - Ajay M Verma
- Digestive Diseases, Kettering General Hospital NHS Foundation Trust, Kettering, UK
| | | |
Collapse
|
48
|
Bojesen RD, Eriksen JR, Vogelsang RP, Grube C, Forman JL, Gogenür I. The dynamic effects of preoperative intravenous iron in anaemic patients undergoing surgery for colorectal cancer. Colorectal Dis 2021; 23:2550-2558. [PMID: 34166572 DOI: 10.1111/codi.15789] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/13/2021] [Revised: 06/02/2021] [Accepted: 06/18/2021] [Indexed: 12/21/2022]
Abstract
AIM The aim of this study was to describe the dynamic changes in blood work following individual adjusted dosage of intravenously administered iron(III) isomaltoside in a 4-week period prior to surgery in patients with colorectal cancer. METHODS This was a single-centre, observational cohort study with prospectively collected data, including patients with colorectal cancer receiving preoperative treatment with iron(III) isomaltoside. Blood samples were taken at baseline, 1 week, 2 weeks and 4 weeks after initial treatment. Sixty-two patients were included in the study. RESULTS Sixty-two patients were included for final analysis. The mean increase in haemoglobin was 0.77 g/dl (95% CI 0.52-1.03 g/dl, P < 0.0001) at week 1, 1.5 g/dl (95% CI 1.21-1.80 g/dl, P < 0.0001) at week 2 and 2.13 g/dl (95% CI 1.71-2.55 g/dl, P < 0.0001) at week 4. Patients with severe anaemia (<9.02 g/dl) showed the largest increase in haemoglobin during the treatment course (2.92 g/dl, 95% CI 2.27-3.58 g/dl, P < 0.0001). Patients with mild anaemia (>10.31 g/dl) did not show a significant increase (0.66 g/dl, 95% CI -0.29-1.61 g/dl, P = 0.17). The mean of transferrin saturation after 4 weeks was 8% (95% CI 6%-10%, P < 0.0001). CONCLUSIONS After intravenously administered iron, patients with severe anaemia had the most substantial increase in haemoglobin, and the increase was largest after 4 weeks. Patients with mild anaemia did not have an increase in haemoglobin during the treatment course. The vast majority of patients still had iron deficiency at surgery 4 weeks after the initial treatment.
Collapse
Affiliation(s)
- Rasmus Dahlin Bojesen
- Department of Surgery, Slagelse Hospital, Slagelse, Denmark.,Centre for Surgical Science, Zealand University Hospital, Køge, Denmark
| | | | | | - Camilla Grube
- Department of Surgery, Slagelse Hospital, Slagelse, Denmark.,Centre for Surgical Science, Zealand University Hospital, Køge, Denmark
| | - Julie Lyng Forman
- Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
| | - Ismail Gogenür
- Centre for Surgical Science, Zealand University Hospital, Køge, Denmark
| |
Collapse
|
49
|
Cococcioni L, Pensabene L, El-Khouly S, Chadokufa S, McCartney S, Saliakellis E, Kiparissi F, Borrelli O. Ferric carboxymaltose treatment for iron deficiency anemia in children with inflammatory bowel disease: Efficacy and risk of hypophosphatemia. Dig Liver Dis 2021; 53:830-834. [PMID: 33775573 DOI: 10.1016/j.dld.2021.02.017] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/29/2020] [Revised: 01/23/2021] [Accepted: 02/16/2021] [Indexed: 12/11/2022]
Abstract
BACKGROUND Although intravenous ferric carboxymaltose (FCM) is effective in treating iron deficiency anemia (IDA) in paediatric inflammatory bowel disease (pIBD), no data are available on its post-infusion related risks. AIMS We assessed the efficacy of FCM and the rate of post-infusion hypophosphatemia in a large cohort of children with IBD and IDA. METHODS All children with IBD with IDA treated with FCM over 5-year period were reviewed. Disease activity, biohumoral assessment and treatments were evaluated at baseline, 4-6 and 12 weeks after each infusion. RESULTS 128 patients [median age at first infusion: 13 years] were identified, 81 (63.3%) were <14 years, 10 (7.8%) <6 years. Eighty-three children (64.8%) received one infusion, whilst 45 (35.2%) repeated infusions. A significant increase in Hb (p<0.001), iron (p<0.001) and ferritin (p<0.001) was observed 4-6 and 12 weeks post-infusion. Hb gain was unrelated to disease severity. Low baseline iron was the main predicting factor for repeated infusions (p<0.05). Three patients reported infusion reactions, none <6 years. Twenty-five children had low post-infusion serum phosphate (11 were <14 years, 3 <6 years). Two children developed severe hypophosphatemia. CONCLUSIONS FCM administration is effective for IDA management in pIBD, including children <6 years. Due to the high prevalence of post-infusion hypophosphatemia, serum phosphate monitoring should be mandatory.
Collapse
Affiliation(s)
- Lucia Cococcioni
- Department of Pediatric Gastroenterology, Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, WC1N 3HZ London, UK; Paediatric Department, "V. Buzzi" Children's Hospital, University of Milan, Milan, Italy
| | - Licia Pensabene
- Department of Pediatric Gastroenterology, Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, WC1N 3HZ London, UK; Department of Surgical and Medical Sciences, Pediatric Unit, University of Catanzaro "Magna Graecia", Catanzaro, Italy
| | - Sara El-Khouly
- Department of Pediatric Gastroenterology, Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, WC1N 3HZ London, UK
| | - Sibongile Chadokufa
- Department of Pediatric Gastroenterology, Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, WC1N 3HZ London, UK
| | - Sara McCartney
- Gastroenterology Department, University College London Hospital, London, UK
| | - Efstratios Saliakellis
- Department of Pediatric Gastroenterology, Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, WC1N 3HZ London, UK
| | - Fevronia Kiparissi
- Department of Pediatric Gastroenterology, Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, WC1N 3HZ London, UK
| | - Osvaldo Borrelli
- Department of Pediatric Gastroenterology, Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, WC1N 3HZ London, UK; Stem Cells and Regenerative Medicine, UCL Institute of Child Health, 30 Guilford Street, London, UK.
| |
Collapse
|
50
|
Abstract
Introduction: Iron Deficiency Anemia (IDA) is a leading cause of anemia in Inflammatory Bowel disease (IBD). IDA affects quality of life (QoL) and lead to developmental and cognitive abnormalities. Diagnosis of IDA in IBD is complicated as biochemical tests available at present cannot help distinguish between IDA and anemia of chronic disease. Soluble transferrin receptor ferritin index has been gaining popularity as it can diagnose IDA in presence of chronic inflammation. ECCO guidelines recommend a Hb increase of >2 g/dL and a TfS of >30% within 4 weeks as adequate therapeutic response. IV iron is preferred over oral iron as it bypasses gastrointestinal tract, rapidly increases haemoglobin, and is not associated with intestinal inflammation. Our aim in this review is to provide apathway for physicians to help them diagnose and appropriately treat IDA in IBD.Areas covered: In this review article, we have discussed current diagnosis and treatment in detail and have proposed new directions on how future research can help manage IDA in IBD effectively.Expert opinion: Understanding the pathogenesis of IDA in IBD will further lead to exploring new potential diagnostic tests and treatment regimens for effective management of IDA in IBD.
Collapse
Affiliation(s)
- Yash Shah
- Department of Internal Medicine, Hackensack Meridian Health Ocean Medical Center, Brick Township, NJ, USA
| | - Dhruvan Patel
- Department of Gastroenterology and Hepatology, Mercy Fitzgerald Hospital, Darby, PA, USA
| | - Nabeel Khan
- Department of Gastroenterology and Hepatology, Corporal Michael J Crescenz VA Medical Center, Philadelphia, PA, USA.,Perelman School of Medicine, University of Pennsylvania, Pennsylvania, PA, USA
| |
Collapse
|