Efficacy and safety of ferric derisomaltose (FDI) compared with iron sucrose (IS) in patients with iron deficiency anemia after bariatric surgery
Obesity surgery. 2022
PURPOSE Iron deficiency is common following bariatric surgery, and treatment with intravenous iron is often required. This post hoc analysis of data from two randomized, open-label, multicenter trials evaluated the efficacy and safety of ferric derisomaltose (FDI; formerly iron isomaltoside 1000) versus iron sucrose (IS) over 4 weeks in adults with iron deficiency anemia (IDA) resulting from prior bariatric surgery. MATERIALS AND METHODS Data were pooled for participants who received FDI or IS in the PROVIDE or FERWON-IDA trials for the treatment of IDA post bariatric surgery. Efficacy outcomes included changes in hemoglobin (Hb) and iron parameters; safety outcomes included the incidence of adverse drug reactions (ADRs), serious or severe hypersensitivity reactions (HSRs), and hypophosphatemia. RESULTS The analysis included 159 patients. Mean (standard deviation) cumulative iron doses were 1199 (± 347) mg for FDI and 937 (± 209) mg for IS. Compared with IS, FDI resulted in a faster and more pronounced Hb response, and a higher proportion of responders (Hb level increase ≥ 2 g/dL from baseline) at all time points. The incidence of ADRs was similar with FDI and IS (15.1% and 18.2%, respectively), with no serious ADRs or serious or severe HSRs reported. The incidence of hypophosphatemia was low and similar in both treatment groups, with no cases of severe hypophosphatemia observed. CONCLUSIONS In patients with IDA resulting from bariatric surgery, FDI produced a faster and more pronounced Hb response than IS. Both FDI and IS were well tolerated.
Single-dose intravenous ferric carboxymaltose infusion versus multiple fractionated doses of intravenous iron sucrose in the treatment of post-operative anaemia in colorectal cancer patients: a randomised controlled trial
Blood transfusion = Trasfusione del sangue. 2021
BACKGROUND Recent clinical guidelines suggest that treatment of postoperative anaemia in colorectal cancer surgery with intravenous iron reduces transfusion requirements and improves outcomes. The study aimed at comparing two intravenous iron regimens in anaemic patients after colorectal cancer surgery. MATERIALS AND METHODS This was a single-centre, open-label, randomised, controlled trial in patients undergoing elective colorectal cancer surgery. Patients with moderate to severe anaemia (haemoglobin [Hb] <11 g/dL) after surgery were randomly assigned 1:1 to receive ferric carboxymaltose (FC; 1,000 mg, single dose) or iron sucrose (IS; 200 mg every 48 hours until covering the total iron deficit or discharge). Randomisation was stratified by Hb level: <10 g/dL (Group A) or ≥10-10.9 (Group B). The primary endpoint was the change in Hb concentration at postoperative day 30. Secondary endpoints included iron status parameters, transfusion requirements, complications, and length of hospital stay. RESULTS From September 2015 to May 2018, 104 patients were randomised (FC 50, IS 54). The median intravenous iron dose was 1,000 mg and 600 mg in the FC and IS groups, respectively. There were no between-group differences in mean change in Hb from postoperative day 1 to postoperative day 30 (FC: 2.5 g/dL, 95% CI: 2.1-2.9; IS: 2.4 g/dL, 95% CI: 2.0-2.8; p=0.52), in transfusion requirements or length of stay. The infection rate was lower in the FC group compared with the IS group (9.8% vs 37.2%, respectively). DISCUSSION The administration of approximately 500 mg of IS resulted in an increase in Hb at postoperative day 30 similar to that of 1,000 mg of FC, but it was associated with a higher infection rate. Future research will be needed to confirm the results, and to choose the best regime in terms of effectiveness and side effects to treat postoperative anaemia in colorectal cancer patients.
Intravenous iron supplementation after liver surgery: Impact on anemia, iron, and hepcidin levels-a randomized controlled trial
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.
Iron supplementation following bariatric surgery: A systematic review of current strategies
Obesity reviews : an official journal of the International Association for the Study of Obesity. 2021
Iron deficiency (ID) and iron deficiency anemia (IDA) are common following bariatric surgery; however, there are limited standardized treatment recommendations for their management. The purpose of this study was to review the current strategies for iron supplementation following bariatric surgery and assess their relative efficacy in managing ID and IDA. MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials were searched to January 2021. Primary outcomes of interest were prevention or improvement in ID or IDA with iron supplementation. Forty-nine studies with 12,880 patients were included. Most patients underwent Roux-en-Y gastric bypass (61.9%). Iron supplementation was most commonly administered orally for prevention of ID/IDA and was effective in 52% of studies. Both IV and oral iron were given for treatment of ID/IDA. Fifty percent (3/6) of the oral and 100% (3/3) of the IV supplementation strategies were effective at treating ID. Iron supplementation strategies employed following bariatric surgery are highly variable, and many do not provide sufficient iron to prevent the development of ID and IDA, potentially due to poor patient adherence. Further high-quality prospective trials, particularly comparing intravenous and oral iron, are warranted in order to determine the ideal dosage, route, and duration of iron supplementation.
Preoperative intravenous iron to treat anaemia before major abdominal surgery (PREVENTT): a randomised, double-blind, controlled trial
Lancet (London, England). 2020
BACKGROUND Preoperative anaemia affects a high proportion of patients undergoing major elective surgery and is associated with poor outcomes. We aimed to test the hypothesis that intravenous iron given to anaemic patients before major open elective abdominal surgery would correct anaemia, reduce the need for blood transfusions, and improve patient outcomes. METHODS In a double-blind, parallel-group randomised trial, we recruited adult participants identified with anaemia at preoperative hospital visits before elective major open abdominal surgery at 46 UK tertiary care centres. Anaemia was defined as haemoglobin less than 130 g/L for men and 120 g/L for women. We randomly allocated participants (1:1) via a secure web-based service to receive intravenous iron or placebo 10-42 days before surgery. Intravenous iron was administered as a single 1000 mg dose of ferric carboxymaltose in 100 mL normal saline, and placebo was 100 mL normal saline, both given as an infusion over 15 min. Unblinded study personnel prepared and administered the study drug; participants and other clinical and research staff were blinded to treatment allocation. Coprimary endpoints were risk of the composite outcome of blood transfusion or death, and number of blood transfusions from randomisation to 30 days postoperatively. The primary analysis included all randomly assigned patients with data available for the primary endpoints; safety analysis included all randomly assigned patients according to the treatment received. This study is registered, ISRCTN67322816, and is closed to new participants. FINDINGS Of 487 participants randomly assigned to placebo (n=243) or intravenous iron (n=244) between Jan 6, 2014, and Sept 28, 2018, complete data for the primary endpoints were available for 474 (97%) individuals. Death or blood transfusion occurred in 67 (28%) of the 237 patients in the placebo group and 69 (29%) of the 237 patients in the intravenous iron group (risk ratio 1·03, 95% CI 0·78-1·37; p=0·84). There were 111 blood transfusions in the placebo group and 105 in the intravenous iron group (rate ratio 0·98, 95% CI 0·68-1·43; p=0·93). There were no significant differences between the two groups for any of the prespecified safety endpoints. INTERPRETATION Preoperative intravenous iron was not superior to placebo to reduce need for blood transfusion when administered to patients with anaemia 10-42 days before elective major abdominal surgery. FUNDING UK National Institute of Health Research Health Technology Assessment Program.
Adults with preoperative anaemia before elective major open abdominal surgery (n= 487).
Intravenous iron: 1000 mg dose of ferric carboxymaltose (n= 244).
Placebo: 100 mL normal saline (n= 243).
Death or blood transfusion occurred in 67 (28%) of the 237 patients in the placebo group and 69 (29%) of the 237 patients in the intravenous iron group. There were 111 blood transfusions in the placebo group and 105 in the intravenous iron group. There were no significant differences between the two groups for any of the prespecified safety endpoints.
Iron, Vitamin B(12), Folate and Copper Deficiency After Bariatric Surgery and the Impact on Anaemia: a Systematic Review
Obesity surgery. 2020
Bariatric surgery may increase the risk of iron, vitamin B(12), folate and copper deficiencies, which can cause anaemia. This review aims to critique the evidence on the prevalence of these nutritional deficiencies and the impact on anaemia in the first 12 months after surgery. PRISMA and MOOSE frameworks, the NHMRC evidence hierarchy and The Academy of Nutrition and Dietetics bias tool were used to systematically critique current literature. Seventeen studies reported on deficiency prevalence with the majority being of low quality. Important confounders to serum micronutrient levels were not adequately considered. Results on the prevalence of nutritional anaemias were also lacking. Further investigation into the prevalence of iron, vitamin B(12), folate and copper deficiency and its impact on anaemia in bariatric surgery is needed.
Epidemiology of parvovirus B19 and anemia among kidney transplant recipients: A meta-analysis
Urology annals. 2020;12(3):241-247
BACKGROUND Persistent anemia has been described in kidney transplant (KTx) recipients with parvovirus B19 virus infection. However, the epidemiology of parvovirus B19 and parvovirus B19-related anemia after KTx remains unclear. We conducted this systematic review (1) to investigate the incidence of parvovirus B19 infection after KTx and (2) to assess the incidence of parvovirus B19 among KTx patients with anemia. MATERIALS AND METHODS A systematic review was conducted in EMBASE, MEDLINE, and Cochrane databases from inception to March 2019 to identify studies that reported the incidence rate of parvovirus B19 infection and/or seroprevalence of parvovirus B19 in KTx recipients. Effect estimates from the individual studies were extracted and combined using random-effects, generic inverse variance method of DerSimonian and Laird. The protocol for this systematic review is registered with PROSPERO (no. CRD42019125716). RESULTS Nineteen observational studies with a total of 2108 KTx patients were enrolled. Overall, the pooled estimated seroprevalence of parvovirus B19 immunoglobulin G was 62.2% (95% confidence interval [CI]: 45.8%-76.1%). The pooled estimated incidence rate of positive parvovirus B19 DNA in the 1(st) year after KTx was 10.3% (95% CI: 5.5%-18.4%). After sensitivity analysis excluded a study that solely included KTx patients with anemia, the pooled estimated incidence rate of positive parvovirus B19 DNA after KTx was 7.6% (95% CI: 3.7%-15.0%). Among KTx with anemia, the pooled estimated incidence rate of positive parvovirus B19 DNA was 27.4% (95% CI: 16.6%-41.7%). Meta-regression analysis demonstrated no significant correlations between the year of study and the incidence rate of positive parvovirus B19 DNA (P = 0.33). Egger's regression asymmetry test was performed and demonstrated no publication bias in all analyses. CONCLUSION The overall estimated incidence of positive parvovirus B19 DNA after KTX is 10.3%. Among KTx with anemia, the incidence rate of positive parvovirus B19 DNA is 27.4%. The incidence of positive parvovirus B19 DNA does not seem to decrease overtime.
A randomized controlled trial comparing oral and intravenous iron supplementation after Roux-en-Y gastric bypass surgery
Clin Nutr. 2020
BACKGROUND Iron deficiency (ID) is one of the most common postoperative deficiencies that may develop after Roux-en-Y gastric bypass (RYGB). The optimal mode of treatment is uncertain. AIM: To compare the efficacy of oral ferrous fumarate (FF), oral ferrous gluconate (FG), and a single intravenous infusion of ferric carboxymaltose (FCM) in women with ID after RYGB. METHODS Multicenter randomized controlled trial including 120 women with a serum ferritin <20 mug/l during follow-up after RYGB. They were randomized into three groups: 41 patients were treated with FF 200 mg three times a day (total daily dose: 195 mg elemental iron), 39 received FG 695 mg twice a day (total daily dose: 160 mg elemental iron) for three months, and 39 patients were treated with a single intravenous dose of FCM (1000 mg elemental iron). Serum ferritin levels were measured at six weeks, and three, six and twelve months after the start of supplementation. RESULTS At three months, persistence of ID was observed in 29.4% and 42.4% of the patients treated with FF and FG, respectively, but in none of those treated with FCM (p < 0.001). Over the next nine months, recurrence of ID was observed in 56.5% of patients treated with FF, in 52.9% treated with FG, and in 27.8% of those treated with FCM. Adverse effects were most common during oral treatment. CONCLUSION In women developing ID after RYGB, a single dose of intravenous FCM is more effective and better tolerated than the standard treatment with either FF or FG. CLINICAL TRIAL REGISTRY NUMBER AND WEBSITE The study was registered at clinicaltrials.gov under number NCT02271997.
Treating Posttransplant Anemia With Erythropoietin Improves Quality of Life but Does Not Affect Progression of Chronic Kidney Disease
Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation. 2019
OBJECTIVES Posttransplant anemia affects 30% to 45% of kidney transplant recipients and is associated with increased morbidity. However, there is lack of evidence about safe hemoglobin levels after erythropoietin treatment. Studies are needed to better understand the potential benefits and risks, as well as to define safe target hemoglobin ranges in these patients. MATERIALS AND METHODS In this single-center exploratory, open-label randomized controlled trial, kidney trans-plant recipients with anemia 3 months posttransplant were either treated with epoetin beta to a hemoglobin target level of 11.5 to 13.5 g/dL (n = 28) or given no treatment (n = 27). Treatment effects on graft function and health quality of life were assessed. RESULTS After 2 years, hemoglobin concentrations were significantly higher in the epoetin beta treatment group than in the no treatment group (12.3 +/- 0.18 vs 9.99 +/- 0.22 g/dL; P < .0001). Estimated glomerular filtration rate, calculated by Modified Diet in Renal Disease 7, declined by 1.7 mL/min (interquartile range, -6 to 4.24) in the epoetin treatment group and by 4.16 mL/min (interquartile range, -12.42 to 2.78) in the no treatment group (P = .32). Rate of progression, determined by estimated glomerular filtration rate slope, was not significantly different between groups (-0.09 +/- 0.1 vs -0.12 +/- 0.15 mL/min for treated vs not treated; P = .78). Moreover, we observed no significant differences in proteinuria and blood pressure. Treated patients had greater improvements in the vitality and mental health domains of the Medical Outcomes Short Form Health Survey quality of life scores. CONCLUSIONS Treatment of anemia in kidney transplant recipients to a hemoglobin level of 11.5 to 13.5 g/dL with erythropoietin improves some quality of life scores. The treatment was safe and not associated with adverse outcomes. There were no changes in rate of decline of graft function.
The incidence of iron deficiency anemia post-Roux-en-Y gastric bypass and sleeve gastrectomy: a systematic review
Surgical endoscopy. 2019
SETTING The physiological and anatomical changes that occur as a consequence of bariatric surgery result in macro- and micro-nutritional deficiencies, especially iron deficiency. The reported incidence of iron deficiency and associated anemia after bariatric surgery varies widely across studies. OBJECTIVES The aim of this systematic review is to quantify the impact of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) on the incidence of iron deficiency. METHODS Databases including Ovid Medline, Ovid Embase, Helthstar, Scopus, Cochrane (CDSR), LILACS, and ClinicalKey were searched for original articles with additional snowballing search. Search terms included Obesity, nutrient deficiency, iron deficiency, iron deficiency anemia, bariatric surgery, Roux-en-Y gastric bypass, and sleeve gastrectomy. Original articles reporting the incidence of iron deficiency and anemia pre- and post-RYGB and SG from January 2000 to January 2015 with minimum 1-year follow-up were selected. Data extraction from selected studies was based on protocol-defined criteria. RESULTS There were 1133 articles screened and 20 studies were included in the final analysis. The overall incidence of iron deficiency was 15.2% pre-operatively and 16.6% post-operatively. When analyzed by procedure, the incidence of iron deficiency was 12.9% pre-RYGB versus 24.5% post-RYGB and 36.6% pre-SG versus 12.4% post-SG. The incidence of iron deficiency-related anemia was 16.7% post-RYGB and 1.6% post-SG. Risk factors for iron deficiency were premenopausal females, duration of follow-up, and pre-operative iron deficiency. Prophylactic iron supplementation was reported in 16 studies and 2 studies provided therapeutic iron supplementation only for iron-deficient patients. Iron dosage varied from 7 to 80 mg daily across studies. CONCLUSION Iron deficiency is frequent in people with obesity and may be exacerbated by bariatric surgery, especially RYGB. Further investigation is warranted to determine appropriate iron supplementation dosages following bariatric surgery. Careful nutritional surveillance is important, especially for premenopausal females and those with pre-existing iron deficiency.