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1.
J Obstet Gynaecol Res ; 47(10): 3464-3470, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34342089

RESUMO

BACKGROUND: There is limited clinical evidence of ferric carboxymaltose injection (FCM) usage in Indian pregnant women. We assessed the efficacy and safety of FCM in Indian pregnant women with moderate-to-severe anemia. METHODS: Single-center, retrospective, observational data collection was conducted at a tertiary care research institute. Data of pregnant women with anemia who received FCM in their second and third trimester was retrieved and analyzed for hematological parameters at baseline and at 4 ± 2 weeks. Neonatal outcomes were also assessed. Adverse events and other safety parameters were noted. RESULTS: Data of 271 patients was retrieved and analyzed for safety and data for 168 patients analyzed for efficacy. A significant increase in hemoglobin was noted with FCM in 4 weeks (1.25 g/dL; p < 0.001). Patients with severe anemia reported an increase in hemoglobin of 4.23 g/dL (p = 0.01). Patients receiving FCM in the second trimester noted a significant increase in hemoglobin of 1.74 g/dL (p < 0.001). A significant increase in hemoglobin was noted as early as 20 days (p < 0.001) and also in patients receiving FCM after 34 weeks (p = 0.002). No adverse fetal or neonatal outcomes were observed. Adverse events noted in 4% of patients with itching and rash being most common. Continuous monitoring of blood pressure, heart rate, and oxygen saturation for 40 min during and after FCM administration reported no deterioration or negative safety signal. CONCLUSION: FCM corrects anemia in all subsets of Indian pregnant women and supports evidence of efficacy and safety. Continuous monitoring of vital parameters during FCM infusions supports its excellent safety.


Assuntos
Anemia Ferropriva , Feminino , Compostos Férricos/efeitos adversos , Humanos , Recém-Nascido , Maltose/efeitos adversos , Maltose/análogos & derivados , Gravidez , Estudos Retrospectivos , Resultado do Tratamento
3.
Lancet Haematol ; 8(7): e503-e512, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34171281

RESUMO

BACKGROUND: Numerous iron preparations are available for the treatment of iron deficiency anaemia in pregnancy. We aimed to provide a summary of the effectiveness and safety of iron preparations used in this setting. METHODS: We did a systematic review and network meta-analysis of randomised trials. We searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, trial registers, and grey literature for trials published in any language from Jan 1, 2011, to Feb 28, 2021. We included trials including pregnant women with iron deficiency anaemia and evaluating iron preparations, irrespective of administration route, with at least 60 mg of elemental iron, in comparison with another iron or non-iron preparation. Three authors independently selected studies, extracted data, and did a risk of bias assessment using the Cochrane tool (version 1.0). The primary outcome was the effectiveness of iron preparations, evaluated by changes in haemoglobin concentration at 4 weeks from baseline. The secondary outcomes were change in serum ferritin concentration at 4 weeks from baseline and treatment-related severe and non-severe adverse events. We did random-effects pairwise and network meta-analyses. Side-effects were reported descriptively for each trial. This study is registered with PROSPERO, CRD42018100822. FINDINGS: Among 3037 records screened, 128 full-text articles were further assessed for eligibility. Of the 53 eligible trials (reporting on 9145 women), 30 (15 interventions; 3243 women) contributed data to the network meta-analysis for haemoglobin and 15 (nine interventions; 1396 women) for serum ferritin. The risk of bias varied across the trials contributing to network meta-analysis, with 22 of 30 trials in the network meta-analysis for haemoglobin judged to have a high or medium global risk of bias. Compared with oral ferrous sulfate, intravenous iron sucrose improved both haemoglobin (mean difference 7·17 g/L, 95% CI 2·62-11·73; seven trials) and serum ferritin (mean difference 49·66 µg/L, 13·63-85·69; four trials), and intravenous ferric carboxymaltose improved haemoglobin (mean difference 8·52 g/L, 0·51-16·53; one trial). The evidence for other interventions compared with ferrous sulfate was insufficient. The most common side-effects with oral iron preparations were gastrointestinal effects (nausea, vomiting, and altered bowel movements). Side-effects were less common with parenteral iron preparations, although these included local pain, skin irratation, and, on rare occasions, allergic reactions. INTERPRETATION: Iron preparations for treatment of iron deficiency anaemia in pregnancy vary in effectiveness, with good evidence of benefit for intravenous iron sucrose and some evidence for intravenous ferric carboxymaltose. Clinicians and policy makers should consider the effectiveness of individual preparations before administration, to ensure effective treatment. FUNDING: None.


Assuntos
Anemia Ferropriva/tratamento farmacológico , Compostos Férricos/uso terapêutico , Óxido de Ferro Sacarado/uso terapêutico , Compostos Ferrosos/uso terapêutico , Maltose/análogos & derivados , Feminino , Compostos Férricos/efeitos adversos , Óxido de Ferro Sacarado/efeitos adversos , Ferritinas/sangue , Compostos Ferrosos/efeitos adversos , Hemoglobinas/análise , Humanos , Maltose/efeitos adversos , Maltose/uso terapêutico , Náusea/etiologia , Gravidez
4.
Medicine (Baltimore) ; 100(20): e24571, 2021 May 21.
Artigo em Inglês | MEDLINE | ID: mdl-34011020

RESUMO

INTRODUCTION: Iron deficiency anemia (IDA) is common among obstetric and gynecologic patients. This systematic review aimed to assess the comparative efficacy and safety of commonly used intravenous (IV) iron formulations, ferric carboxymaltose (FCM), and iron sucrose (IS) in the treatment of IDA in obstetric and gynecologic patients. METHODS: We systematically searched PubMed, EMBASE, Cochrane CENTRAL, and Google Scholar for eligible randomized controlled trials (RCTs) comparing IV iron replacement using FCM and IS up to October 2019. The primary outcome was to compare the efficacy of FCM and IS, assessed by measuring serum hemoglobin (Hb) and ferritin levels before and after iron replacement. The secondary outcome was to compare the safety of FCM and IS, assessed by the incidence of adverse events during iron replacement. The meta-analysis was performed using RevMan 5.3. RESULTS: We identified 9 RCTs with 910 patients (FCM group, n = 456; IS group, n = 454). Before iron replacement, FCM and IS group patients had similar baseline Hb (mean difference [MD], 0.04 g/dL; 95% confidence interval [CI], -0.07 to 015; I2 = 0%; P = 0.48) and ferritin levels (MD, -0.42 ng/mL; 95% CI, -1.61 to 0.78; I2 = 45%; P = 0.49). Following iron replacement, patients who received FCM had higher Hb (MD, 0.67; 95% CI, 0.25-1.08; I2 = 92%; P = 0.002) and ferritin levels (MD, 24.41; 95% CI, 12.06-36.76; I2 = 75%; P = 0.0001) than patients who received IS. FCM group showed a lower incidence of adverse events following iron replacement than IS group (risk ratio, 0.53; 95% CI, 0.35-0.80; I2 = 0%; P = 0.003). Serious adverse events were not reported in any group. CONCLUSION: FCM group showed better efficacy in increasing Hb and ferritin levels and a favorable safety profile with fewer adverse events compared with IS group for IDA treatment among obstetric and gynecologic patients. However, this meta-analysis was limited by the small number of RCTs and high heterogeneity. TRIAL REGISTRATION: The review was prospectively registered with the International Prospective Registry of Systematic Reviews (https://www.crd.york.ac.uk/prospero/, registration number CRD42019148905).


Assuntos
Anemia Ferropriva/tratamento farmacológico , Compostos Férricos/administração & dosagem , Óxido de Ferro Sacarado/administração & dosagem , Hematínicos/administração & dosagem , Maltose/análogos & derivados , Complicações Hematológicas na Gravidez/tratamento farmacológico , Administração Intravenosa , Anemia Ferropriva/sangue , Anemia Ferropriva/diagnóstico , Anemia Ferropriva/etiologia , Feminino , Compostos Férricos/efeitos adversos , Óxido de Ferro Sacarado/efeitos adversos , Ferritinas/sangue , Hematínicos/efeitos adversos , Hemoglobinas/análise , Humanos , Maltose/administração & dosagem , Maltose/efeitos adversos , Gravidez , Complicações Hematológicas na Gravidez/sangue , Complicações Hematológicas na Gravidez/diagnóstico , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
5.
Surgery ; 170(3): 813-821, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33888314

RESUMO

BACKGROUND: Anemia is a recognized risk factor for perioperative related morbidity and mortality and is frequently reported in liver surgeries with an estimated incidence of 32%. We aim to assess the impact of intravenous iron administration in the immediate postoperative period on anemia and iron status as well as to determine the kinetics of hepcidin after liver surgery. METHODS: The HepciFer trial, a randomized controlled trial, included 50 patients undergoing liver surgery. In accordance with the randomization process, patients received either ferric carboxymaltose (15 mg/kg, maximum 1 g) or placebo 4 hours after surgery. RESULTS: The mean hemoglobin level, 7 days after surgery, did not differ significantly between the intervention and control group (11.1 ± 1.8 g/dL and 10.4 ± 1.6 g/dL, respectively) with a mean difference of +0.7 g/dL ([95% confidence interval, -0.3 to +1.7], P = .173). Within patients receiving intravenous iron supplementation, none presented biological signs of functional iron deficiency. Hepcidin levels remained significantly higher during the observation period in the intervention group. Inflammatory biomarkers, red blood cells transfusion rate and hospital duration of stay were similar between groups. CONCLUSION: Intravenous ferric carboxymaltose administration did not result in a significant increase of hemoglobin levels 7 days after surgery. However, this study suggests that intravenous iron supplementation in the immediate postoperative settings prevents functional iron deficiency. Intravenous iron supplementation overcame the hepcidin-mediated blockade of iron absorption and should be considered as the preferred route of administration in the postoperative period.


Assuntos
Anemia/prevenção & controle , Compostos Férricos/uso terapêutico , Hepatectomia/efeitos adversos , Hepcidinas/sangue , Ferro/sangue , Maltose/análogos & derivados , Cuidados Pós-Operatórios/métodos , Complicações Pós-Operatórias/prevenção & controle , Idoso , Anemia/etiologia , Proteína C-Reativa/análise , Compostos Férricos/efeitos adversos , Ferritinas/sangue , Humanos , Infusões Intravenosas , Interleucina-6/sangue , Masculino , Maltose/efeitos adversos , Maltose/uso terapêutico
6.
Sci Rep ; 11(1): 7463, 2021 04 02.
Artigo em Inglês | MEDLINE | ID: mdl-33811227

RESUMO

In non-dialysis-dependent chronic kidney disease (NDD-CKD), erythropoiesis-stimulating agents (ESAs) and iron supplementation are essential for anemia management. Ferric carboxymaltose (FCM) is a relatively novel intravenous iron formulation used in different clinical settings, although scarce data exist in NDD-CKD patients. Primary objective of this study was to retrospectively evaluate the efficacy of FCM compared with oral ferrous sulfate for the treatment of iron-deficiency anemia in a cohort of NDD-CKD patients, considering also the treatment costs. This was a monocentric, retrospective observational study reviewing 349 NDD-CKD patients attending an outpatient clinic between June 2013 and December 2016. Patients were treated by either FCM intravenous infusion or oral ferrous sulfate. We collected serum values of hemoglobin, ferritin and transferrin saturation (TSAT) and ESAs doses at 12 and 18 months. The costs related to both treatments were also analysed. 239 patients were treated with FCM intravenous infusion and 110 patients with oral ferrous sulfate. The two groups were not statistically different for age, BMI and eGFR values. At 18 months, hemoglobin, serum ferritin and TSAT values increased significantly from baseline in the FCM group, compared with the ferrous sulfate group. ESAs dose and rate of infusion decreased only in the FCM group. At 18 months, the treatment costs, analysed per week, was higher in the ferrous sulfate group, compared with the FCM group, and this was mostly due to a reduction in ESAs prescription in the FCM group. Routine intravenous FCM treatment in an outpatient clinic of NDD-CKD patients results in better correction of iron-deficiency anemia when compared to ferrous sulfate. In addition to this, treating NDD-CKD patients with FCM leads to a significant reduction of the treatment costs by reducing ESAs use.


Assuntos
Anemia/tratamento farmacológico , Anemia/economia , Custos e Análise de Custo , Compostos Férricos/uso terapêutico , Compostos Ferrosos/uso terapêutico , Maltose/análogos & derivados , Insuficiência Renal Crônica/complicações , Idoso , Anemia/sangue , Anemia/complicações , Darbepoetina alfa/uso terapêutico , Compostos Férricos/efeitos adversos , Compostos Ferrosos/efeitos adversos , Testes Hematológicos , Hemoglobinas/análise , Humanos , Ferro/sangue , Maltose/efeitos adversos , Maltose/uso terapêutico , Insuficiência Renal Crônica/sangue , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento
9.
Cochrane Database Syst Rev ; 1: CD013529, 2021 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-33471939

RESUMO

BACKGROUND: Inflammatory bowel disease affects approximately seven million people globally. Iron deficiency anaemia can occur as a common systemic manifestation, with a prevalence of up to 90%, which can significantly affect quality of life, both during periods of active disease or in remission. It is important that iron deficiency anaemia is treated effectively and not be assumed to be a normal finding of inflammatory bowel disease. The various routes of iron administration, doses and preparations present varying advantages and disadvantages, and a significant proportion of people experience adverse effects with current therapies. Currently, no consensus has been reached amongst physicians as to which treatment path is most beneficial. OBJECTIVES: The primary objective was to evaluate the efficacy and safety of the interventions for the treatment of iron deficiency anaemia in people with inflammatory bowel disease. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and two other databases on 21st November 2019. We also contacted experts in the field and searched references of trials for any additional trials. SELECTION CRITERIA: Randomised controlled trials investigating the effectiveness and safety of iron administration interventions compared to other iron administration interventions or placebo in the treatment of iron deficiency anaemia in inflammatory bowel disease. We considered both adults and children, with studies reporting outcomes of clinical, endoscopic, histologic or surgical remission as defined by study authors. DATA COLLECTION AND ANALYSIS: Two review authors independently conducted data extraction and 'Risk of bias' assessment of included studies. We expressed dichotomous and continuous outcomes as risk ratios and mean differences with 95% confidence intervals. We assessed the certainty of the evidence using the GRADE methodology. MAIN RESULTS: We included 11 studies (1670 randomised participants) that met the inclusion criteria. The studies compared intravenous iron sucrose vs oral iron sulphate (2 studies); oral iron sulphate vs oral iron hydroxide polymaltose complex (1 study); oral iron fumarate vs intravenous iron sucrose (1 study); intravenous ferric carboxymaltose vs intravenous iron sucrose (1 study); erythropoietin injection + intravenous iron sucrose vs intravenous iron sucrose + injection placebo (1 study); oral ferric maltol vs oral placebo (1 study); oral ferric maltol vs intravenous ferric carboxymaltose (1 study); intravenous ferric carboxymaltose vs oral iron sulphate (1 study); intravenous iron isomaltoside vs oral iron sulphate (1 study); erythropoietin injection vs oral placebo (1 study). All studies compared participants with CD and UC together, as well as considering a range of disease activity states. The primary outcome of number of responders, when defined, was stated to be an increase in haemoglobin of 20 g/L in all but two studies in which an increase in 10g/L was used. In one study comparing intravenous ferric carboxymaltose and intravenous iron sucrose, moderate-certainty evidence was found that intravenous ferric carboxymaltose was probably superior to intravenous iron sucrose, although there were responders in both groups (150/244 versus 118/239, RR 1.25, 95% CI 1.06 to 1.46, number needed to treat for an additional beneficial outcome (NNTB) = 9). In one study comparing oral ferric maltol to placebo, there was low-certainty evidence of superiority of the iron (36/64 versus 0/64, RR 73.00, 95% CI 4.58 to 1164.36). There were no other direct comparisons that found any difference in the primary outcomes, although certainty was low and very low for all outcomes, due to imprecision from sparse data and risk of bias varying between moderate and high risk. The reporting of secondary outcomes was inconsistent. The most common was the occurrence of serious adverse events or those requiring withdrawal of therapy. In no comparisons was there a difference seen between any of the intervention agents being studied, although the certainty was very low for all comparisons made, due to risk of bias and significant imprecision due to the low numbers of events. Time to remission, histological and biochemical outcomes were sparsely reported in the studies. None of the other secondary outcomes were reported in any of the studies. An analysis of all intravenous iron preparations to all oral iron preparations showed that intravenous administration may lead to more responders (368/554 versus 205/373, RR 1.17, 95% CI 1.05 to 1.31, NNTB = 11, low-certainty due to risk of bias and inconsistency). Withdrawals due to adverse events may be greater in oral iron preparations vs intravenous (15/554 versus 31/373, RR 0.39, 95% CI 0.20 to 0.74, low-certainty due to risk of bias, inconsistency and imprecision). AUTHORS' CONCLUSIONS: Intravenous ferric carboxymaltose probably leads to more people having resolution of IDA (iron deficiency anaemia) than intravenous iron sucrose. Oral ferric maltol may lead to more people having resolution of IDA than placebo. We are unable to draw conclusions on which of the other treatments is most effective in IDA with IBD (inflammatory bowel disease) due to low numbers of studies in each comparison area and clinical heterogeneity within the studies. Therefore, there are no other conclusions regarding the treatments that can be made and certainty of all findings are low or very low. Overall, intravenous iron delivery probably leads to greater response in patients compared with oral iron, with a NNTB (number needed to treat) of 11. Whilst no serious adverse events were specifically elicited with any of the treatments studied, the numbers of reported events were low and the certainty of these findings very low for all comparisons, so no conclusions can be drawn. There may be more withdrawals due to such events when oral is compared with intravenous iron delivery. Other outcomes were poorly reported and once again no conclusions can be made as to the impact of IDA on any of these outcomes. Given the widespread use of many of these treatments in practice and the only guideline that exists recommending the use of intravenous iron in favour of oral iron, research to investigate this key issue is clearly needed. Considering the current ongoing trials identified in this review, these are more focussed on the impact in specific patient groups (young people) or on other symptoms (such as fatigue). Therefore, there is a need for studies to be performed to fill this evidence gap.


Assuntos
Anemia Ferropriva/terapia , Colite Ulcerativa/complicações , Doença de Crohn/complicações , Hematínicos/administração & dosagem , Adolescente , Adulto , Idoso , Anemia Ferropriva/complicações , Viés , Dissacarídeos/administração & dosagem , Dissacarídeos/efeitos adversos , Eritropoetina/administração & dosagem , Compostos Férricos/administração & dosagem , Compostos Férricos/efeitos adversos , Óxido de Ferro Sacarado/administração & dosagem , Óxido de Ferro Sacarado/efeitos adversos , Fumaratos/administração & dosagem , Fumaratos/efeitos adversos , Hematínicos/efeitos adversos , Humanos , Compostos de Ferro/administração & dosagem , Compostos de Ferro/efeitos adversos , Maltose/administração & dosagem , Maltose/efeitos adversos , Maltose/análogos & derivados , Pessoa de Meia-Idade , Placebos/administração & dosagem , Pironas/administração & dosagem , Pironas/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Adulto Jovem
10.
Am J Hematol ; 96(5): 606-616, 2021 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-33471363

RESUMO

Phosphorus has an essential role in cellular and extracellular metabolism; maintenance of normal phosphorus homeostasis is critical. Phosphorus homeostasis can be affected by diet and certain medications; some intravenous iron formulations can induce renal phosphate excretion and hypophosphatemia, likely through increasing serum concentrations of intact fibroblast growth factor 23. Case studies provide insights into two types of hypophosphatemia: acute symptomatic and chronic hypophosphatemia, while considering the role of pre-existing conditions and comorbidities, medications, and intravenous iron. This review examines phosphorus homeostasis and hypophosphatemia, with emphasis on effects of iron deficiency and iron replacement using intravenous iron formulations.


Assuntos
Hipofosfatemia/etiologia , Ferro/efeitos adversos , Fósforo/metabolismo , Anemia Hipocrômica/tratamento farmacológico , Calcitriol/fisiologia , Compostos Férricos/administração & dosagem , Compostos Férricos/efeitos adversos , Compostos Férricos/farmacologia , Fatores de Crescimento de Fibroblastos/biossíntese , Fatores de Crescimento de Fibroblastos/genética , Fatores de Crescimento de Fibroblastos/fisiologia , Homeostase/efeitos dos fármacos , Homeostase/fisiologia , Humanos , Hipofosfatemia/induzido quimicamente , Hipofosfatemia/diagnóstico , Hipofosfatemia/terapia , Infusões Parenterais , Ferro/administração & dosagem , Ferro/deficiência , Rim/metabolismo , Síndromes de Malabsorção/complicações , Maltose/administração & dosagem , Maltose/efeitos adversos , Maltose/análogos & derivados , Maltose/farmacologia , Osteomalacia/etiologia , Hormônio Paratireóideo/fisiologia , Fósforo na Dieta/farmacocinética
11.
Intern Med J ; 51(8): 1304-1311, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33462917

RESUMO

BACKGROUND: Ferric carboxymaltose is increasingly utilised to treat iron deficiency and is usually diluted in saline and administered as an intravenous infusion over 15 min. Although this is highly convenient compared with older formulations, we hypothesised the drug could be administered, safely given as a rapid bolus injection. AIMS: To define the risk of serious adverse events following administration of an undiluted, rapid, high-dose ferric carboxymaltose injection. Secondary aims included all other adverse events, as well as longitudinal effects on haemoglobin, iron stores, phosphate and hepcidin. METHODS: In a single-arm, Phase II study in 121 patients with iron-deficiency anaemia, we administered up to 1000 mg of ferric carboxymaltose as a rapid undiluted bolus injection, and recorded adverse events and collected blood samples over the first hour, and again at 2 and 4 weeks post-treatment. RESULTS: No patient experienced a serious adverse event. Flushing during the injection was common, as was a transient headache in the subsequent weeks. One patient experienced Grade 3 chest tightness, necessitating emergency department assessment but not admission or treatment. Treatment produced an average 12.3 g/L improvement in haemoglobin within 2 weeks, but commonly caused reductions in serum phosphate (although none of these was clinically symptomatic). Parenteral iron caused elevations in hepcidin sustained to 4 weeks post-injection. Patients stated they would be prepared to receive the treatment again. CONCLUSION: Rapid injection of undiluted ferric carboxymaltose is well tolerated and could provide an approach to treat patients in the ambulatory setting.


Assuntos
Anemia Ferropriva , Anemia Ferropriva/tratamento farmacológico , Compostos Férricos/efeitos adversos , Humanos , Ferro , Maltose/efeitos adversos , Maltose/análogos & derivados
13.
Ann Pharmacother ; 55(2): 222-229, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-32633548

RESUMO

OBJECTIVE: To review the pharmacology, efficacy, and safety of ferric maltol (FM), an oral iron formulation, for iron deficiency anemia (IDA). DATA SOURCES: A MEDLINE/PubMed and EMBASE (January 1, 1985, to June 19, 2020) literature search was performed using the terms ferric maltol, accrufer, feraccru, iron maltol, ferric trimaltol, iron deficiency, iron deficiency anemia, inflammatory bowel disease, and chronic kidney disease. Additional data sources included prescribing information, abstracts, and the National Institutes of Health Clinical Trials Registry. STUDY SELECTION/DATA EXTRACTION: English language literature evaluating FM pharmacology, pharmacokinetics, efficacy, or safety in the treatment of IDA were reviewed. DATA SYNTHESIS: FM is a ferric, non-salt-based oral iron formulation demonstrating improved tolerance in patients with previous intolerance to other iron formulations. Phase 3 trials demonstrated significant improvements in anemia and serum iron parameters in patients with inflammatory bowel disease (IBD) and chronic kidney disease (CKD). Common adverse effects were gastrointestinal intolerance. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: FM is an effective and well-tolerated alternative to oral iron salts for patients with IBD or CKD and IDA. Emerging data suggest that FM is noninferior to intravenous (IV) ferric carboxymaltose in patients with IBD and IDA. Prior to selecting FM over IV iron products, consideration should be given to time to normalization of Hb, ease of administration, cost, and tolerability. CONCLUSION: FM is a relatively safe, effective oral iron therapy that may be better tolerated than other oral iron formulations. FM may be an effective alternative to IV iron in patients with IBD.


Assuntos
Anemia Ferropriva/tratamento farmacológico , Compostos Férricos/uso terapêutico , Hematínicos/uso terapêutico , Pironas/uso terapêutico , Administração Intravenosa , Administração Oral , Adulto , Anemia Ferropriva/sangue , Anemia Ferropriva/complicações , Ensaios Clínicos como Assunto , Feminino , Compostos Férricos/administração & dosagem , Compostos Férricos/efeitos adversos , Compostos Férricos/farmacocinética , Hematínicos/administração & dosagem , Hematínicos/efeitos adversos , Hematínicos/farmacocinética , Humanos , Doenças Inflamatórias Intestinais/complicações , Doenças Inflamatórias Intestinais/tratamento farmacológico , Masculino , Maltose/administração & dosagem , Maltose/efeitos adversos , Maltose/análogos & derivados , Maltose/uso terapêutico , Pironas/administração & dosagem , Pironas/efeitos adversos , Pironas/farmacocinética , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/tratamento farmacológico , Resultado do Tratamento
14.
Mol Med Rep ; 22(4): 3525-3532, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32945423

RESUMO

α­glucosidase is a key enzyme that plays a role in glucose absorption in the gastrointestinal tract, and the inhibition of its activity induces the prevention of postprandial hyperglycemia. Several α­glucosidase inhibitors have been used as medicines for type 2 diabetes, but a similar effect is observed in natural resources, including traditional herbs and their phytochemicals. To identify the presence of the α­glucosidase inhibitory activity in herbs, in which various functional effects have been known to occur, the present study investigated the effects of hot­water extracts of 26 types of herbs on α­glucosidase activity in an in vitro assay. The results indicated significant increases in the inhibition of α­glucosidase activity in 1,000 µg/ml olive (P<0.01), white willow (P<0.01) and red rooibos hot­water extracts. Furthermore, ≥50% inhibition of α­glucosidase activity was determined to be significant in 1,000 µg/ml coltsfoot, green tea and bearberry hot­water extracts. In addition, the effects of bearberry, green tea and coltsfoot hot­water extracts on α­glucosidase activity in vivo were evaluated according to the blood glucose levels (BGLs) in maltose and glucose load model rats. It was indicated that the administration of these three herb extracts significantly reduced the increasing BGLs after maltose loading until 0.5 h compared with the control group. However, only coltsfoot extract significantly reduced the increasing BGLs after glucose loading until 0.5 h compared with the control group. Thus, the present results may facilitate the understanding of a novel functionality in traditional herbs, which could be useful for the prevention of disease onset and progression, such as in hyperglycemia and type 2 diabetes.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Inibidores de Glicosídeo Hidrolases/administração & dosagem , Plantas Medicinais/química , Água/administração & dosagem , alfa-Glucosidases/metabolismo , Animais , Arctostaphylos/química , Aspalathus/química , Diabetes Mellitus Tipo 2/induzido quimicamente , Diabetes Mellitus Tipo 2/enzimologia , Modelos Animais de Doenças , Glucose/efeitos adversos , Inibidores de Glicosídeo Hidrolases/química , Inibidores de Glicosídeo Hidrolases/farmacologia , Temperatura Alta , Masculino , Maltose/efeitos adversos , Olea/química , Extratos Vegetais/administração & dosagem , Extratos Vegetais/química , Extratos Vegetais/farmacologia , Ratos , Salix/química , Chá/química , Tussilago/química , Água/química , Água/farmacologia
15.
Clin Lab ; 66(8)2020 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-32776750

RESUMO

BACKGROUND: Anemia is a frequent disorder worldwide. Iron deficiency anemia (IDA) is the most common form of anemia. Although oral iron is the first choice for treatment, the efficacy of oral iron preparations may be limited. Ferric carboxymaltose (FCM) is a novel parenteral iron preparation which can rapidly replenish iron stores. The aim of the present study is to investigate the impact of FCM dose on hemoglobin (Hb) and ferritin levels and the frequency of hypersensitivity reactions. METHODS: This study was conducted with 765 IDA patients between September 1, 2016 and September 1, 2018. He-moglobin (Hb), serum ferritin, transferrin saturation values were examined at the time of diagnosis, Hb and ferritin values at first month. RESULTS: Post-treatment Hb and ferritin levels significantly increased. The mean Hb level alteration was 2.43 ± 1.2 g/dL, the median ferritin level alteration was 157.3 ng/mL. The mean Hb level was lower and the mean change in Hb level was higher in higher doses. Allergic reactions were more frequent in higher doses. CONCLUSIONS: Ferric carboxymaltose is a novel treatment option with a low risk of hypersensitivity reactions and well tolerated even in high doses.


Assuntos
Anemia Ferropriva , Maltose , Anemia Ferropriva/diagnóstico , Anemia Ferropriva/tratamento farmacológico , Compostos Férricos/efeitos adversos , Ferritinas , Hemoglobinas/metabolismo , Humanos , Maltose/efeitos adversos , Maltose/análogos & derivados
16.
Cancer Sci ; 111(10): 3862-3872, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32741012

RESUMO

Although intake of highly sugary foods is considered to be a potential risk factor for colorectal cancer through hyperinsulinemia, the association of sugar intake and colorectal adenoma, a precursor lesion to most colorectal cancer, is poorly understood, particularly in Asian populations. We undertook a cross-sectional study in a Japanese population to investigate the association between dietary sugar intake and the prevalence of colorectal adenoma. Study subjects were selected from participants who underwent magnifying colonoscopy with dye spraying as part of a cancer screening program and who responded to a self-administered questionnaire before the colonoscopy. A total of 738 cases with colorectal adenoma and 697 controls were enrolled. Dietary intakes of glucose, fructose, galactose, sucrose, maltose, lactose, and total sugars (sum of these six mono- or disaccharides) were calculated from a food frequency questionnaire, and divided into quartiles based on the distribution among controls. Odds ratios and 95% confidence intervals of colorectal adenoma were estimated using unconditional logistic regression models, with adjustment for potential confounding factors. Total sugar intake was not significantly associated with the prevalence of colorectal adenoma (odds ratio for the highest intake group compared to reference group = 1.18; 95% confidence interval, 0.81-1.73; P for trend = .34). Furthermore, no statistically significant positive associations were observed for any of the six mono- or disaccharides. Findings were similar on additional analyses by site, size, and number of adenomas. Our findings do not support an association between high sugar intake and increased odds ratios of colorectal adenoma.


Assuntos
Adenoma/epidemiologia , Neoplasias Colorretais/epidemiologia , Açúcares da Dieta/efeitos adversos , Detecção Precoce de Câncer , Adenoma/induzido quimicamente , Adulto , Idoso , Colonoscopia , Neoplasias Colorretais/induzido quimicamente , Neoplasias Colorretais/patologia , Estudos Transversais , Dieta/efeitos adversos , Feminino , Frutose/efeitos adversos , Galactose/efeitos adversos , Glucose/efeitos adversos , Humanos , Japão/epidemiologia , Lactose/efeitos adversos , Masculino , Maltose/efeitos adversos , Pessoa de Meia-Idade , Estado Nutricional , Fatores de Risco , Sacarose/efeitos adversos , Inquéritos e Questionários
18.
Acute Med ; 19(2): 102-105, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32840261

RESUMO

Ferric carboxymaltose (Ferinject®) is an infusion administered for the treatment of iron deficiency anaemia. A number of previous case reports have shown the occurrence of hypophosphataemia after Ferinject® treatment, supposedly managed though high dose phosphate therapy. This case report highlights the risk associated with, and futility of, managing this adverse effect through high dose phosphate infusion. A review of the available literature suggests that if hypophosphataemia develops as a result of Ferinject®, through upregulation of the renal protein Fibroblast Growth Factor-23, it cannot be readily reversed and on average persists for circa 50 days. Acute medical units should be aware of this - likely underreported - adverse effect, and avoid treating these hypophosphataemic patients with high dose phosphate since it can compound symptoms.


Assuntos
Hipofosfatemia , Maltose , Compostos Férricos/efeitos adversos , Humanos , Hipofosfatemia/induzido quimicamente , Hipofosfatemia/tratamento farmacológico , Hipofosfatemia/epidemiologia , Incidência , Maltose/efeitos adversos , Maltose/análogos & derivados
19.
BMC Med ; 18(1): 178, 2020 07 13.
Artigo em Inglês | MEDLINE | ID: mdl-32654663

RESUMO

BACKGROUND: In patients with iron deficiency anemia, ferric carboxymaltose (FCM) and ferric derisomaltose (FDI) allow high-dose iron repletion. While FCM is reported to induce hypophosphatemia, the frequency of hypophosphatemia after an equivalent dosage of FDI had not been assessed prospectively. METHODS: In the prospective, single-center, double-blind HOMe aFers study, 26 women with iron deficiency anemia (hemoglobin < 12 g/dL plus either plasma ferritin ≤ 100 ng/mL or a plasma ferritin ≤ 300 ng/mL and transferrin saturation (TSAT) ≤ 30%) were randomized to a single intravenous infusion of 20 mg/kg body weight (up to a maximum of 1000 mg) FCM or FDI. The primary endpoint was the incidence of hypophosphatemia (plasma phosphorus levels < 2.0 mg/dL at day 1, day 7 ± 2, and/or day 35 ± 2 after the infusion). In order to investigate potential skeletal and cardiovascular implications, we assessed changes in other components of mineral and bone metabolism, left ventricular function, and arrhythmias. RESULTS: Hypophosphatemia occurred more frequently in women treated with FCM (9 out of 12 [75%]) than in those treated with FDI (1 out of 13 [8%]; p = 0.001). Within 24 h after iron supplementation, women in the FCM group had significant higher plasma intact FGF23 (p < 0.001) and lower plasma 1.25-dihydroxyvitamin D (p < 0.001). As an indicator of urinary phosphorus losses, urinary fractional phosphorus excretion was higher in the FCM group (p = 0.021 at day 7 ± 2 after iron supplementation). We did not observe differences in skeletal and cardiovascular markers, potentially because of the limited number of participants. CONCLUSIONS: While both FCM and FDI provide efficient iron repletion in participants with iron deficiency anemia, FCM induced hypophosphatemia more often than FDI. TRIAL REGISTRATION: Clinical Trials.gov NCT02905539. Registered on 8 September 2016. 2015-004808-36 (EudraCT Number) U1111-1176-4563 (WHO Universal Trial Number) DRKS00010766 (Deutsches Register Klinischer Studien).


Assuntos
Anemia Ferropriva/complicações , Compostos Férricos/efeitos adversos , Hipofosfatemia/etiologia , Ferro/sangue , Maltose/análogos & derivados , Adulto , Anemia Ferropriva/sangue , Método Duplo-Cego , Feminino , Humanos , Masculino , Maltose/efeitos adversos , Estudos Prospectivos
20.
BMC Gastroenterol ; 20(1): 183, 2020 Jun 10.
Artigo em Inglês | MEDLINE | ID: mdl-32522150

RESUMO

BACKGROUND: Intravenous iron replacement is recommended for iron-deficient patients with inflammatory bowel disease (IBD), but may be associated with hypophosphataemia, predisposing to osteomalacia and fractures. This study aimed to evaluate the incidence and risk factors for hypophosphataemia following intravenous ferric carboxymaltose (FCM) in patients with IBD. METHODS: This prospective observational study of patients with and without IBD evaluated serum phosphate for 28 days following intravenous FCM, and assessed associations with symptoms, markers of inflammation and vitamin D status. RESULTS: Twenty-four patients with IBD (11 with Crohn's disease [CD], 13 with ulcerative colitis [UC], mean age 45 years [range 19-90], 7 female), and 20 patients without IBD (mean age 56 [22-88] y, 11 female), were included. Overall, serum phosphate declined by a mean of 36% at Day 7, with a mean fall of 42% (SD 19%) at some time point over 28 days (p <  0.001). Twenty-four of 44 (55%) patients developed moderate to severe hypophosphataemia (serum phosphate < 0.6 mmol/L). No differences between patients with and without IBD were seen, but patients with CD had greater decline in phosphate than those with UC. There was no association between hypophosphataemia and symptomatic adverse events, faecal calprotectin, C-reactive protein, albumin, platelet count, 25(OH) vitamin D, or 1,25(di-OH) vitamin D. Serum phosphate < 1.05 mmol/L on Day 2 predicted susceptibility to moderate-severe hypophosphataemia (OR 7.0). CONCLUSIONS: Hypophosphataemia following FCM is common, unrelated to symptomatic adverse events, baseline intestinal or systemic inflammation, or vitamin D status.


Assuntos
Anemia Ferropriva/tratamento farmacológico , Colite Ulcerativa/complicações , Doença de Crohn/complicações , Compostos Férricos/efeitos adversos , Hipofosfatemia/epidemiologia , Maltose/análogos & derivados , Administração Intravenosa , Adulto , Idoso , Idoso de 80 Anos ou mais , Anemia Ferropriva/etiologia , Colite Ulcerativa/sangue , Doença de Crohn/sangue , Feminino , Compostos Férricos/administração & dosagem , Humanos , Hipofosfatemia/induzido quimicamente , Incidência , Masculino , Maltose/administração & dosagem , Maltose/efeitos adversos , Pessoa de Meia-Idade , Estado Nutricional , Fosfatos/sangue , Estudos Prospectivos , Fatores de Risco , Resultado do Tratamento , Vitamina D/sangue , Adulto Jovem
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