Effect Of Ferric Carboxymaltose Research Articles

The Effect of Ferric Carboxymaltose on Fibroblast Growth Factor 23 (FGF23) in Children with Iron Deficiency Anemia Due to Gastrointestinal Diseases

Background: Hypophosphatemia is a known side-effect of parenteral iron administration, especially after intravenous ferric carboxymaltose (FCM). Fibroblast growth factor 23 (FGF23) is thought to play an important role in the pathophysiology of serum phosphate homeostasis. This study aimed to investigate the effects of FCM on FGF23 serum levels in FCM-treated pediatric patients with iron deficiency (ID)/iron deficiency anemia (IDA) caused by gastrointestinal diseases. Methods: Over 30 months, FGF23 serum levels were assessed prospectively in children with ID/IDA due to gastrointestinal diseases and treated with FCM infusion. Serum levels of intact FGF23 (iFGF23) were assessed and correlated to phosphate serum levels and factors of bone metabolism. Blood sampling was performed in three phases: before FCM infusion, 7–10 days after FCM infusion, and 6–8 weeks after FCM infusion. Results: A total of 42 FCM infusions were given to 35 children (20 girls) with a mean age (±SD) of 12.2 (±4.03) years (range: 2–16 years). The median levels of iFGF23 did not show a significant difference across the three phases (p = 0.56). No significant correlation was found between iFGF23 levels and 25-hydroxyvitamin D/parathyroid hormone/serum phosphate/serum calcium/alkaline phosphatase. No significant change was noted between pre- and post-treatment serum phosphate levels. However, four children (11.42%) developed asymptomatic and transient hypophosphatemia. Conclusions: No significant difference was found between pre-and post-FCM infusion serum iFGF23 levels and bone metabolism parameters. An increase of iFGF23 serum levels 7–10 days after FCM infusion was noted in patients with hypophosphatemia.

Effect of ferric carboxymaltose in the iron deficiency anemia patients undergoing cardiac surgery: A randomized clinical trial

Effect of ferric carboxymaltose in the iron deficiency anemia patients undergoing cardiac surgery: A randomized clinical trial

Association between sex and efficacy of intravenous ferric carboxymaltose in patients with acute heart failure and iron deficiency: an AFFIRM-AHF subgroup analysis

Abstract Background/Introduction Heart failure (HF) pathophysiology, clinical presentation and treatment response is known to differ between males and females (1). In the AFFIRM-AHF trial, intravenous (IV) ferric carboxymaltose (FCM) reduced the risk of HF hospitalisations and improved quality of life vs placebo in patients with iron deficiency who had stabilised following an acute HF (AHF) episode (2,3); the effect of sex on outcomes with iron-repletion therapy in these high-risk patients has not been fully explored. Purpose To investigate the interaction between sex and the effects of FCM vs placebo on clinical outcomes in the AFFIRM-AHF population. Methods In AFFIRM-AHF, patients with left ventricular ejection fraction <50% and iron deficiency (defined as serum ferritin <100 ng/mL, or 100–299 ng/mL if transferrin saturation is <20%) who had stabilised following recent hospitalisation for AHF were randomised 1:1 to receive IV FCM or placebo for up to 24 weeks.2 The primary endpoint was a composite of total HF hospitalisations and cardiovascular (CV) death up to Week 52; secondary endpoints are listed in the Figure.2 In this prespecified analysis, AFFIRM-AHF patients were stratified into male and female subgroups and the interaction between sex and clinical outcomes with FCM vs placebo was explored. Results Of the 1108 patients included in the AFFIRM-AHF full analysis set, 614 (FCM: 314; placebo: 300) were male and 494 (FCM: 244; placebo: 250) were female. At baseline, a New York Heart Association functional class of III and above was more common in females (59.0%) than in males (48.4%). For the primary endpoint, the adjusted annualised event rate per 100 patient-years with FCM vs placebo was 53.3 vs 83.3 in males (rate ratio [RR] 0.64; 95% confidence interval [CI] 0.46–0.89) and 63.1 vs 60.3 in females (RR 1.05; 95% CI 0.72–1.53) (Figure). For all secondary endpoints except time to CV death, effect sizes in male and female subgroups were similar to those for the primary endpoint. The interaction between sex and treatment effect was non-significant for the primary endpoint (P-interaction=0.054) but reached significance for the secondary endpoints of total CV hospitalisations and CV death (P-interaction=0.024) and time to first HF hospitalisation or CV death (P-interaction=0.043). Conclusion(s) The results of this exploratory subgroup analysis suggest that iron deficiency treatment with IV FCM following an AHF episode may be more effective in males than in females; this may be related to baseline differences between sex subgroups, beyond the factors adjusted for in this analysis.Figure

Ferric Carboxymaltose in Heart Failure with Iron Deficiency

BackgroundFerric carboxymaltose therapy reduces symptoms and improves quality of life in patients who have heart failure with a reduced ejection fraction and iron deficiency. Additional evidence about the effects of ferric carboxymaltose on clinical events is needed.MethodsIn this double-blind, randomized trial, we assigned ambulatory patients with heart failure, a left ventricular ejection fraction of 40% or less, and iron deficiency, in a 1:1 ratio, to receive intravenous ferric carboxymaltose or placebo, in addition to standard therapy for heart failure. Ferric carboxymaltose or placebo was given every 6 months as needed on the basis of iron indexes and hemoglobin levels. The primary outcome was a hierarchical composite of death within 12 months after randomization, hospitalizations for heart failure within 12 months after randomization, or change from baseline to 6 months in the 6-minute walk distance. The significance level was set at 0.01.ResultsWe enrolled 3065 patients, of whom 1532 were randomly assigned to the ferric carboxymaltose group and 1533 to the placebo group. Death by month 12 occurred in 131 patients (8.6%) in the ferric carboxymaltose group and 158 (10.3%) in the placebo group; a total of 297 and 332 hospitalizations for heart failure, respectively, occurred by month 12; and the mean (±SD) change from baseline to 6 months in the 6-minute walk distance was 8±60 and 4±59 m, respectively (Wilcoxon–Mann–Whitney P=0.02; unmatched win ratio, 1.10; 99% confidence interval, 0.99 to 1.23). Repeated dosing of ferric carboxymaltose appeared to be safe with an acceptable adverse-event profile in the majority of patients. The number of patients with serious adverse events occurring during the treatment period was similar in the two groups (413 patients [27.0%] in the ferric carboxymaltose group and 401 [26.2%] in the placebo group).ConclusionsAmong ambulatory patients who had heart failure with a reduced ejection fraction and iron deficiency, there was no apparent difference between ferric carboxymaltose and placebo with respect to the hierarchical composite of death, hospitalizations for heart failure, or 6-minute walk distance. (Funded by American Regent, a Daiichi Sankyo Group company; HEART-FID ClinicalTrials.gov number, NCT03037931.)

Intravenous ferric carboxymaltose for iron repletion following acute heart failure in patients with and without diabetes: a subgroup analysis of the randomized AFFIRM-AHF trial.

In AFFIRM-AHF, treatment of iron deficiency with intravenous ferric carboxymaltose (FCM) reduced the risk of heart failure (HF) hospitalization and improved quality of life (QoL) vs placebo in patients stabilized following an acute HF (AHF) episode, with no effect on cardiovascular (CV) death. Diabetes and iron deficiency frequently accompany AHF. This post hoc analysis explored the effects of diabetes on outcomes in AFFIRM-AHF patients. Patients were stratified by diabetes yes/no at baseline. The effects of FCM vs placebo on primary (total HF hospitalizations and CV death) and secondary (total CV hospitalizations and CV death; CV death; total HF hospitalizations; time to first HF hospitalization or CV death; and days lost due to HF hospitalizations or CV death) endpoints at Week 52 and change vs baseline in disease-specific QoL (12-item Kansas City Cardiomyopathy Questionnaire [KCCQ-12]) at Week 24 were assessed by subgroup. For each endpoint, the interaction between diabetes status and treatment outcome was explored. Of 1108 AFFIRM-AHF patients, 475 (FCM: 231; placebo: 244) had diabetes and 633 (FCM:327; placebo: 306) did not have diabetes. Patients with diabetes were more commonly male (61.5% vs 50.9%), with a higher frequency of ischemic HF etiology (57.9% vs 39.0%), prior HF history (77.7% vs 66.5%), and comorbidities (including previous myocardial infarction [49.3% vs 32.9%] and chronic kidney disease [51.4% vs 32.4%]) than those without diabetes. The annualized event rate/100patient-years with FCM vs placebo for the primary endpoint was 66.9 vs 80.9 in patients with diabetes (rate ratio [RR]: 0.83, 95% CI 0.58-1.81) and 51.3 vs 66.9 in patients without diabetes (RR:0.77, 95% CI 0.55-1.07), with no significant interaction between diabetes status and treatment effect (pinteraction = 0.76). Similar findings were observed for secondary outcomes. Change from baseline in KCCQ-12 overall summary score was numerically greater with FCM vs placebo at almost all time points in both subgroups, with no interaction between diabetes and treatment effect at Week 24. The clinical and QoL benefits observed with intravenous FCM in patients with iron deficiency following stabilization from an AHF episode are independent of diabetes status. Trial registration Clinicaltrials.gov, NCT02937454 (registered 10.18.2016).

Effects of ferric carboxymaltose on hemoglobin level after cardiac surgery: A randomized controlled trial

BackgroundPerioperative anemia is common in cardiac surgery. Few studies investigated the effect of postoperative intravenous (IV) iron supplementation and were mostly inconclusive. MethodsDesign: A randomized single-center, double-blind, placebo-controlled, parallel-group trial. Participants: 195 non-anemic patients were recruited from December 2018 to December 2020: 97 patients received 1 g of ferric carboxymaltose (FCM) and 98 patients received 100 mL of physiological serum on postoperative day 1. Measurements: hemoglobin levels, reticulocyte count, serum iron, serum ferritin, and transferrin saturation were measured at induction of anesthesia, postoperative days 1, 5, and 30. Transfusion rate, duration of mechanical ventilation, critical care unit length of stay, and side effects associated with IV iron administration were measured. The primary outcome was hemoglobin level on day 30. Secondary outcomes included iron balance, transfused red cell packs, and critical care unit length of stay. ResultsAt day 30, the hemoglobine level was higher in the FCM group than in the placebo group (mean 12.9 ± 1.2 vs. 12.1 ± 1.3 g/dL (95%CI 0.41–1.23, p-value <0.001)). Patients in the FCM group received fewer blood units (median 1[0-2] unit vs. 2 [0-3] units, p-value = 0.037) and had significant improvement in iron balance compared to the control group. No side effects associated with FCM administration were reported. ConclusionIn this randomized controlled trial, administration of FCM on postoperative day 1 in non-anemic patients undergoing cardiac surgery increased hemoglobin levels by 0.8 g/dL on postoperative day 30, leading to reduced transfusion rate, and improved iron levels on postoperative day 5 and 30. Clinical trial registry numberNCT03759964.

MO531: The Differential Effect of Third-Generation Intravenous Iron Preparations (Ferric Carboxymaltose, Ferric Derisomaltose) on Cardiovascular Parameters in Patients With Non-Dialysis Dependent CKD and Iron Deficiency Anaemia

Abstract BACKGROUND AND AIMS Intravenous (IV) iron is commonly used to alleviate iron deficiency anaemia in patients with non-dialysis chronic kidney disease (CKD). Treatment with IV iron in patients with iron deficiency and heart failure has demonstrated an improvement in functional status and cardiac biomarkers; however, concerns remain regarding the potential pro-oxidative effect of IV iron and possible cardiovascular injury. Newer agents [such as ferric carboxymaltose (FCM) and ferric derisomaltose (FDI)] are increasingly used due to their advantage in delivering large amounts of iron effectively and safely; however, they differ as to their effect on serum phosphate and fibroblast growth factor 23, factors that have been previously shown to affect cardiac function. Given the above potential concerns, it is important to explore the comparative effect of IV iron in this population in terms of cardiac injury and vascular function. METHOD The exploratory single-centre double-blinded randomized controlled trial ‘Iron and Phosphaturia—ExplorIRON-CKD’ aimed primarily to not only assess the differential effects of FCM and FDI on levels of fibroblast growth factor 23 and phosphate, but also explore any cardiovascular effect. Non-dialysis patients with CKD and iron deficiency with/without anaemia defined as serum ferritin &amp;lt;200 µg/L or transferrin saturation ≤20% and serum ferritin 200–299 µg/L were recruited and randomized in a 1:1 ratio. Participants received 1000 mg at baseline and 500–1000 mg at 1 month to achieve replenishment. Measurements of NT-proBNP were taken at baseline, 1 month, 2 months and 3 months, whilst measurements of Troponin T were taken at every visit (total of eight visits). Vascular function was assessed using pulse wave velocity measurements at baseline, 1 month, 2 months and 3 months, monitoring carotid to femoral pulse wave velocity (PWVcf) and aortic augmentation index (AIx). RESULTS Twenty-six patients were recruited; 14 were randomized to receive FDI and 12 to receive FCM. All patients received at least one iron dose (1000 mg), 10 patients received two FDI doses and 11 received two FCM doses. There was a trend to an increase in NT-pro BNP (10.3%) in the combined group, with no statistical difference between the FCM and FDI groups [median for the combined population: baseline: 875.5 (3033.0) ng/L versus Visit 8: 967.0 (2976.0) ng/L] (Figure 1). Troponin T values remained constant throughout the study period in the combined and individual groups (Table 1). A decrease in both PWVcf and AIx was noted in the participants receiving IV iron irrespective of the compound used. A greater decrease was seen in the FDI group in terms of PWVcf; however, there was no statistically significant difference for the percentage change from baseline to the end of the study between the groups (FCM: −4.3 (33.6)% versus FDI: −11.9 (23.4)%; P = .60) (Figure 2). CONCLUSION Treatment of non-dialysis CKD patients with FDI or FCM was not associated with any cardiovascular safety signals. Troponin T was unaffected and there was no worsening in vascular function. Pulse wave velocity improved, as noted by the decreasing trends for PWVcf and AIx. The decrease in PWVcf was greater with FDI than FCM, but the difference was not statistically significant. A small rise in NT-proBNP was noted in the combined group, but there was no statistically significant difference between the FDI and FCM groups. These results suggest that newer IV iron compounds are not associated with any detriment in terms of vascular function and potentially no resulting cardiac insult. The study sample is small and therefore the results should be interpreted with caution; nonetheless, the evidence provided from a comparative view directs to no negative sequela.

Effects of ferric carboxymaltose on phosphate and calcium homeostasis in a murine model of iron‐deficiency anemia

Iron deficiency anemia (IDA) can be caused by heavy uterine bleeding, inflammatory bowel disease, or chronic kidney disease. Ferric carboxymaltose (FCM) is an intravenous form of iron replacement therapy that has been shown clinically to induce severe hypophosphatemia. However, the mechanism by which this occurs is poorly understood. The objective of this study was to develop and characterize a mouse model that would allow investigating the effects of FCM on phosphate (Pi) and calcium (Ca2+) homeostasis. Female C57Bl/6J mice (n=40; 10/group) were randomized to either iron deficient (ID) diet (4 ppm iron) or control diet (48 ppm iron) for 4 weeks followed by intravenous bleeding (0.7% of body weight) 4 and 2 days prior to starting the study. Baseline blood and urine was collected for hematocrit, complete blood count, and serum and urine Pi and Ca2+ levels. Subsequently, mice were treated with a single IV injection of either vehicle (saline) or FCM (20 mg/kg) via retroorbital injection. One week later, terminal blood, urine, feces, liver, and spleen were collected. At baseline, compared with controls, ID mice had lower hematocrit (35±1% vs 39±1%; P&lt;0.05) and microcytic hypochromic anemia. After 7 days, FCM‐treated ID mice had significantly higher hematocrit compared with vehicle‐treated ID mice (43±1% vs 30±1%; P&lt;0.05). FCM treatment also significantly increased iron content in liver and spleen in control mice (18±1 vs 6±1 μmol/g and 36±2 vs 27±3 μmol/g, respectively; P&lt;0.05) and ID mice (16±1 vs 1±0.1 μmol/g and 21±2 vs 6±1 μmol/g, respectively; P&lt;0.05). At baseline, urinary Pi/creatinine ratios were significantly lower in ID mice compared with controls (30±5 vs 58±7 mmol/mmol; P&lt;0.05); however, FCM treatment in ID mice did not affect urinary Pi/creatinine ratios after 7 days (31±6 vs 18±5 mmol/mmol; not significant). There were no differences between groups for serum Pi, erythrocyte Pi, or fecal Pi. Under baseline conditions, no differences in plasma Ca2+ or urinary Ca2+/creatinine ratios were observed between groups; however, FCM‐treated ID mice had significantly lower plasma Ca2+ levels after 7 days compared with ID mice at baseline (2.3±0.1 vs 2.6±0.1 mmol; P&lt;0.05) and lower urinary Ca2+/creatinine ratios (0.1±0.1 vs 1.3±0.2 mmol/mmol; P&lt;0.05). We speculate this may be due to increased PTH and FGF23 levels in FCM‐treated ID mice. In summary, our study demonstrates for the first time that FCM affects Pi and Ca2+ homeostasis in a murine model of IDA. Further studies are needed to better understand the mechanisms of FCM on mineral homeostasis as well as the driving factors for species differences.

The effect of intravenous ferric carboxymaltose on right ventricular function - insights from the IRON-CRT trial.

Ferric carboxymaltose (FCM) improves left ventricular function in heart failure with reduced ejection fraction (HFrEF). Yet, the effect of FCM on right ventricular (RV) function remains insufficiently elucidated. This is a pre-defined analysis of the IRON-CRT trial in which symptomatic HFrEF patients with iron deficiency and reduced left ventricular ejection fraction (LVEF) despite optimal medical therapy and cardiac resynchronization therapy (CRT) underwent 1:1 randomization to FCM or placebo in a double-blind fashion. RV function was measured as the change from baseline to 3-month follow-up in RV fractional area change (FAC), tricuspid annular plane systolic excursion (TAPSE) and pulsed Doppler peak velocity at the RV lateral annulus (RV S'), systolic pulmonary artery pressure (SPAP) and its coupling to the right ventricle (TAPSE/SPAP ratio). The RV contractile reserve was measured as the change in TAPSE during incremental pacing at 70, 90 and 110 bpm. A total of 75 patients underwent randomization and received FCM (n=37) or placebo (n=38). At baseline 72.5% had RV dysfunction and 70% had RV dilatation. At 3-month follow-up, patients receiving FCM had a significant improvement in RV FAC (+4.1% [+1.4% - +6.9%] vs. -2.2% [-4.9% - +0.6%] in the placebo group, p=0.002) and TAPSE (+0.98 mm [+0.28 mm - +1.62 mm] vs. -0.19 mm [-0.85 mm - +0.48 mm] in the placebo group, p=0.020), but not RV S'. Patients receiving FCM had a numerically lower SPAP (p=0.073) and significant improvement in TAPSE/SPAP ratio (+0.097 [+0.048 - +0.146] vs. +0.002 [-0.046 - +0.051] in the placebo group, p=0.008). At baseline both groups had diminished RV contractile reserve during incremental pacing, which was attenuated at 3-month follow-up in the FCM group (p=0.004). Patients manifesting more RV function improvement were more likely to exhibit higher degrees of LVEF improvement (p < 0.05 for all). Treatment with FCM in HFrEF patients results in an improvement in RV function and structure and improves the RV contractile reserve.

Efficacy of intravenous ferric carboxymaltose in patients with acute heart failure and iron deficiency with and without anaemia: a subgroup analysis of AFFIRM-AHF

Abstract Background Iron deficiency is associated with increased morbidity and mortality in patients with acute heart failure (HF), even in the absence of anaemia. Purpose This prespecified subanalysis of the AFFIRM-AHF trial investigated the effects of ferric carboxymaltose (FCM) on recurrent HF hospitalisations and cardiovascular (CV) mortality in patients with and without anaemia defined as baseline haemoglobin (Hb) &amp;lt;12 g/dL, ≥12 g/dL. Methods In total, 1108 patients (558 FCM, 550 placebo) were included in the modified intention-to-treat AFFIRM-AHF analysis. The primary outcome was a composite of total HF hospitalisations and CV death, evaluated up to 52 weeks post-randomisation. Results Of the 1108 patients, 228 and 329 in the FCM group and 236 and 314 in the placebo group had Hb &amp;lt;12 g/dL and ≥12 g/dL at baseline, respectively. For patients with a baseline Hb ≥12 g/dL, the total number of HF hospitalisations and CV death was 156 and 201 in the FCM and placebo groups, respectively, with a rate ratio (95% confidence interval) of 0.67 (0.48–0.93; p=0.016). For patients with Hb &amp;lt;12 g/dL, this was 136 and 171 in the FCM and placebo groups, respectively (0.97 [0.66–1.41; p=0.862]). This treatment effect was consistent for all secondary outcomes in patients in the FCM group vs placebo, for both Hb subgroups (Figure). Conclusion Iron deficiency treatment with FCM following acute HF reduced the risk of HF hospitalisations and CV death, irrespective of Hb level at baseline. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Vifor Pharma Ltd. Figure 1

S1268 Effects of Ferric Carboxymaltose vs Ferumoxytol on Hypophosphatemia in Patients With Iron-Deficiency Anemia Due to Gastrointestinal Disorders

S1268 Effects of Ferric Carboxymaltose vs Ferumoxytol on Hypophosphatemia in Patients With Iron-Deficiency Anemia Due to Gastrointestinal Disorders

Effects of ferric carboxymaltose on markers of mineral and bone metabolism: A single-center prospective observational study of women with iron deficiency.

Two weekly infusions of ferric carboxymaltose (FCM) are commonly prescribed for treatment of iron-deficiency anemia. However, administration of FCM increases intact levels of fibroblast growth factor 23 (FGF23), which causes hypophosphatemia due to renal phosphate wasting, calcitriol deficiency and secondary hyperparathyroidism. The adverse effects of FCM on mineral metabolism and bone health emerged from case reports and secondary analyses of trials. Data on these safety signals with FCM in clinical practice are limited because markers of mineral and bone metabolism are not routinely checked. To obtain real-world experience with effects of FCM on mineral and bone metabolism, we conducted a prospective observational study of 16 women who were managed at a single-center hematology clinic for iron-deficiency anemia. From October 2016 to February 2018, all participants received two weekly infusions of FCM at a hematology infusion clinic. We hypothesized that FCM would decrease phosphate, increase intact FGF23 (iFGF23), and decrease c-terminal FGF23 (cFGF23). Secondary outcomes were changes in hemoglobin, iron indices, urine fractional excretion of phosphate (FePi), parathyroid hormone (PTH), calcitriol, calcium, osteocalcin, and bone-specific alkaline phosphatase (BAP). FCM was administered at weeks zero and one, and we measured laboratory values at weeks zero, one, two, and five of the study. We used linear mixed models to analyze the significance of the changes in laboratory values over time. After two FCM infusions, nearly all (14 of 16) participants developed hypophosphatemia. iFGF23 increased, cFGF23 decreased, and phosphate decreased significantly from week zero to week two (iFGF23 increased by +134.0% [40.6, 305.8], p<0.001; cFGF23 decreased by -516.3% [-1332.7, -142.7], p=0.002; phosphate decreased by -49.8±15.4%, p<0.001). There was also a significant increase in FePi, PTH, and BAP and a significant decrease in calcitriol and calcium from week zero to week two. There was no significant change in osteocalcin during this time period. iFGF23, but not PTH, was independently associated with decreased phosphate. iFGF23 was also significantly associated with decrease in calcitriol from week zero to week two. Elevation in BAP suggests disordered bone mineralization in response to FCM therapy. In this prospective observational study of women with iron deficiency anemia, two FCM infusions significantly altered markers of bone mineralization and mineral metabolism. The results suggest that FCM should be used cautiously in the treatment of iron-deficiency anemia.

Effect of ferric-carboxy maltose on oxygen kinetics and functional status in heart failure patients with iron deficiency.

There is a very high prevalence of iron deficiency anemia in patients with systolic heart failure. The present study is a prospective, parallel, 1:1 randomized controlled trial of intravenous ferric-carboxy maltose compared with standard of care in patients with heart failure. A total of 70 patients who presented to us with symptomatic chronic heart failure were included and randomly assigned to either groups (35 per group). Post 12 weeks, there were improvements noticed in peak VO2, New York Heart Association functional classification, 6-min walk test distance covered and reduction in Minnesota Living with Heart Failure Questionnaire score in the ferric-carboxy maltose as compared with standard of care group. However, no improvement in ejection fraction was noticed.

The Effectiveness of Ferric Carboxymaltose in Childbearing Age with Iron Deficiency Anemia

The Effectiveness of Ferric Carboxymaltose in Childbearing Age with Iron Deficiency Anemia

A cohort study of two intravenous treatments for iron deficiency in patients with heart failure

Background: Iron deficiency (ID) in patients with heart failure (HF) leads to greater morbidity and mortality and its treatment has been associated with significant improvements in quality of life. Since no head-to-head studies are available, there is uncertainty as to which intravenous iron supplement should be used. This study aimed to compare the effect of ferric carboxymaltose (FCM) and iron saccharate (IS) on clinical and biochemical outcomes in patients with HF and ID.Methods: We reviewed electronic health records from a referral centre in Bogotá, Colombia for patients with HF. We selected records with a follow-up of at least 2 years. Primary outcomes were clinically significant changes in EuroQol-5D (EQ-5D) , 6-minute-walk test (6MWT), resolution of ID, and direct costs.Results: We obtained data on 119 patients with a median age of 69 years and a median left ventricular ejection fraction (LVEF) of 35%. All patients met criteria for ID, and 58% were treated with FCM. A significant difference in GFR of 11 mL/min/1.72 m2 was found at baseline between groups. Neither bivariate, nor multivariate analyses could identify significant differences between patients receiving FCM and IS for any of the primary outcomes. Direct cost analysis showed that FCM use generates 2.8 times the cost associated with saccharate use.Conclusions: This retrospective cohort study did not identify any significant differences in clinical or biochemical outcomes between HF patients with ID receiving FCM or IS. Direct cost analysis favoured use of IS in this group of patients.

Effect of ferric carboxymaltose on calculated plasma volume status and clinical congestion: a FAIR-HF substudy.

AimsIron deficiency worsens symptoms, quality of life, and exercise capacity in chronic heart failure (CHF) and might do so by promoting fluid retention. We assessed whether iron repletion improved congestion in CHF and appraised the prognostic utility of calculated plasma volume status (PVS), a novel index of congestion, in the FAIR‐HF data set.Methods and resultsIn FAIR‐HF, 459 iron deficient CHF patients were randomized to intravenous ferric carboxymaltose (FCM) or saline and assessed at 4, 12, and 24 weeks. Using weight and haematocrit, we calculated PVS in 436 patients. At baseline, PVS and weight were −5.5 ± 7.7% and 76.9 ± 14.3 kg, with peripheral oedema evident in 35% of subjects. Higher PVS values correlated to other congestion surrogates such as lower serum albumin. At 4 weeks, FCM was associated with greater reductions in weight (0.02) and PVS (P < 0.0001), and a trend for improved peripheral oedema at 24 weeks (0.07). Irrespective of treatment allocation, patients with a decrease in PVS from baseline to week 24 had higher increments in 6 min walking distance (61.4 m vs. 43.5 m, 0.02) and were more likely to improve their NYHA class (33.3% vs. 15.5%, 0.001). A PVS > −4% at baseline predicted worse outcomes even after adjustment for treatment assignment (hazard ratio 1.88, 95% confidence interval 1.01–3.51, 0.046).ConclusionsIntravenous iron therapy with FCM is associated with early reductions in PVS and weight, implying that decongestion might be one mechanism via which iron repletion aids CHF patients. Calculated PVS is of prognostic utility in this cohort.

The Effectiveness of Ferric Carboxymaltose in Childbearing Age with Iron Deficiency Anemia

The Effectiveness of Ferric Carboxymaltose in Childbearing Age with Iron Deficiency Anemia

Intravenous iron sucrose and ferric carboxymaltose in pregnant patients: an observational study of maternal efficacy and tolerance

AbstractAimTo compare the tolerability and effectiveness of ferric carboxymaltose (FCM) and iron sucrose (FeS) in pregnant women with iron deficiency (ID).MethodsRetrospective audit of pregnant women in their second or third trimesters receiving intravenous (IV) FCM or FeS at an Australian tertiary maternity hospital from January 2007 to July 2013. Demographics, haematological and infusion details, including adverse events and pregnancy outcomes, were compared using Student's t‐test, Chi‐square and Fisher's exact tests.ResultsEighty‐three women had 94 infusions (56 FCM requiring 2 h in Day Stay; 38 FeS requiring 6 h in Acute Care) administered. There were no significant demographic differences between groups. Neither group had anaphylactic reaction or unplanned admission after infusion. Non‐anaphylactic adverse reactions at first infusion were lower in the FCM group (16 vs 34%, p = 0.049). Pre‐infusion mean Hb and ferritin were 98.1 g/L ± 10.8 g/L and 9.7 μg/L ± 6.2 μg/L in the FCM group and 98.3 g/L ± 11.7 g/L and 8.0 μg/L ± 3.9 μg/L in the FeS group. Post‐infusion, both groups had significantly higher Hb and ferritin: rises of 12.7 g/L and 296 μg/L, respectively for FCM (p &lt; 0.001 vs all pre‐infusion values) and rises of 8.9 g/L and 105 μg/L in FeS (p &lt; 0.05 vs all pre‐infusion values). Pregnancy outcomes, including post partum haemorrhage rates, were similar between groups.ConclusionAlthough haematological parameters improved following infusion in both groups, FCM had a lower incidence of infusion‐related adverse events compared to FeS. Although sample size is small, given decreased monitoring and infusion time required for FCM, it may become the preferred formulation for ID treatment in pregnancy.

The Effectiveness of Ferric Carboxymaltose on the Improvement of Chronic Iron Deficiency Anemia in Patients With Colon Cancer: A Controlled Randomized Clinical Trial

The Effectiveness of Ferric Carboxymaltose on the Improvement of Chronic Iron Deficiency Anemia in Patients With Colon Cancer: A Controlled Randomized Clinical Trial

High-dose intravenous treatment in iron deficiency anaemia in inflammatory bowel disease: early efficacy and impact on quality of life.

Anaemia and iron deficiency are very common in inflammatory bowel disease. Clinical trials have shown intravenous iron to be effective and well tolerated. However, published experience in clinical practice with specific evaluation of the effect on quality of life is limited. We carried out a prospective, multicentre, observational study on the effects of ferric carboxymaltose in the treatment of iron deficiency anaemia in inflammatory bowel disease. Anaemia and iron deficiency were defined according to World Health Organization criteria. Efficacy and safety were evaluated at infusion, at 2 weeks and at 12 weeks. Quality of life was evaluated according to the SIBDQ-9 index. Complete response was defined as anaemia correction or more tan 2 g/dL increase in haemoglobin. A total of 88 courses of ferric carboxymaltose in 72 patients were evaluated. Complete response was observed in 46% of patients at week 2, and 81.2% at week 12. Quality of life improved significatively at week 2 in both complete responders and partial responders (p<0.0005); complete responders showed siginficantly better response (p=0.016). No predictive factor was identified. Only one transient adverse effect was observed; however, this was severe. Ferric carboxymaltose showed comparable efficacy to that demonstrated in clinical trials. After only two weeks of treatment, there was a significant improvement in quality of life, with a greater effect observed in those patients with a complete haematologic response. Intravenous iron can very quickly improve quality of life in inflammatory bowel disease.