Efficacy Of Intravenous Ferric Carboxymaltose Research Articles

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

Efficacy and safety of early ferric carboxymaltose treatment in patients with acute decompensated heart failure

BACKGROUND: The efficacy of intravenous ferric carboxymaltose (FCM) therapy in heart failure (HF) with low ejection fraction with iron deficiency (ID) or ID anemia is known. The aim of this study was to determine the efficacy and safety of intravenous FCM therapy in the early decompensated period in acute decompensated HF with low ejection fraction with ID or ID anemia.METHODS: Patients with acute decompensated HF with low ejection fraction (EF<40%) with ID or ID anemia were included in the study. ID was diagnosed according to serum ferritin and transferrin saturation (TSAT) measurement at admission in 26 patients and before discharge in 26 patients, and intravenous FCM treatment was given at the same time. ID was defined as serum ferritin <100 μg/L (absolute ID) or ferritin 100-299 μg/L with a TSAT<20% (functional ID). Cox regression analysis was used to determine the relationship between the time of intravenous iron therapy and the risk of 30-day hospitalization and 6-month rehospitalization and mortality and Linear regression analysis was used for N-terminal pro-brain natriuretic peptide (NT-proBNP) change at 30 days.RESULTS: All patients have either ID or ID anemia. The mean age was 67.0±13.0 years, 58% female. Anemia was more prevalent at admission blood samples than before discharge (P<0.001), and absolute and functional iron deficiency rates were similar (P=0.38 and P=0.19, respectively). 30-day rehospitalization (Hazar ratio [HR]= 0.80, confidence interval [CI] 0.22-2.98, P=0.74) Sixth-month rehospitalization (HR=0.89, CI 0.36-2.20, P=0.80) and Sixth-month mortality (HR=0.51, CI 0.05-5.56, P=0.58) were similar between treatment groups. There was no significant relationship between the time of administration of FCM treatment and the change in pro-BNP levels measured at baseline and 30-day (P=0.90).CONCLUSIONS: In patients with acute decompensated HF with low ejection fraction and ID or ID anemia, the efficacy and safety of intravenous iron therapy applied at admission are similar to before discharge.

COMPARATIVE EVALUATION OF EFFICACY AND SAFETY OF INTRAVENOUS FERRIC CARBOXYMALTOSE VERSUS IRON SUCROSE COMPLEX FOR THE TREATMENT OF MODERATE GRADE ANEMIA IN POST CAESAREAN SECTION WOMEN: A RANDOMIZED AND PROSPECTIVE STUDY

Objective: Iron deficiency anemia is common in postpartum women in India. The present study is aimed at comparing the safety and efficacy ofintravenous ferric carboxymaltose (FCM) with intravenous iron sucrose complex (ISC) in patients who underwent cesarean section and havingmoderate grade anemia in postpartum period.Methods: A prospective and comparative study was carried out in 100 post-cesarean section women with moderate grade anemia hemoglobin (Hb7–9 g%) in Gajra Raja Medical College, Gwalior (M.P.) from February 2019 to August 2020. Subjects were randomly allocated to two groups, namely,FCM and ICS, 50 patients in each group. In group FCM, patients were infused with 1000 mg of FCM in a single dose on 4th post-operative day. Patients inISC group were infused with ISC 200 mg in 100 mL normal saline on 3 alternate days on 4th, 6th, and 8th post-operative day. Mean, Hb mean corpuscularvolume (MCV), mean corpuscular Hb (MCH), and MCH concentration (MCHC) were recorded before start of therapy and 15 days after treatment in allstudy subjects. Mean reticulocyte count was recorded before start of treatment and 2 days after completion of treatment that is on 6th and 10th postcesarean day in FCM and ICS group, respectively. Adverse drug reactions were recorded during the study period. Statistical analysis was done usingStatistical Package for the Social Sciences software.Results: Mean Hb increased by 27% in FCM and by 19% in ISC group and is significant (*p&lt;0.05) from baseline values. FCM showed significantly(**p&lt;0.01) better response, than ISC group. Mean reticulocyte percent showed significant increase by 120% and 73% in FCM and ISC group,respectively, from the baseline and change in mean reticulocyte in FCM was significant (***p&lt;0.001) as compared to ISC. The mean rise in MCV was12% and 5% and MCH was by 10% and 1% in FCM and ISC group, respectively. FCM groups showed significantly better response (p&lt;0.05) than ISC.However, in MCHC, there were 7% and 4% increase in FCM and ISC group, respectively, and on inter group comparison was not significant (p&gt;0.05).Adverse effects noted during the study were mild and responded to symptomatic treatment. Sixteen percentage of FCM cases and 26% of ISC casesunderwent adverse drug reactions that included nausea, vomiting, giddiness, and injection site reactions.Conclusion: FCM is more efficacious and safer than ISC, making it the first line of management in postpartum iron deficiency anemia.

Efficacy of ferric carboxymaltose for treatment of iron deficiency anemia diagnosed in the third trimester of pregnancy: A case-control study.

To assess the efficacy of intravenous ferric carboxymaltose (IV FCM) for the treatment of iron deficiency anemia (IDA) diagnosed de novo in the third trimester of pregnancy. Case-control study conducted in pregnant women with IDA newly diagnosed in the third trimester of pregnancy. Women treated with a single IV FCM injection were included as cases and those who received daily 210 g of oral ferrous sulphate (FS) as controls. Controls were matched to cases in a 2:1 ratio by basal hemoglobin (Hb) concentration (±0.5g/dl). A total of 35 cases and 70 controls were included in the study. The mean Hb concentration level significantly increased after iron treatment in both cases (from 9.3± 0.8 to 11.1± 0.8g/dl, p< 0.0001) and controls (from 9.6± 0.9 to 10.9± 1g/dl, p< 0.0001). The rate of women who exceeded the recommended threshold of 11 g/dl after treatment did not significantly differ between cases (63% (95%CI, 45%-79%)) and controls (56% (95%CI, 44%-68%)) (p= 0.48). Comparison of maternal and neonatal outcomes and adverse effects did not show any significant difference between groups. Our results suggest that IV FCM and oral FS can be considered equally effective in the treatment of IDA newly detected in the third trimester of pregnancy.

Impact of ischaemic aetiology on the efficacy of intravenous ferric carboxymaltose in patients with iron deficiency and acute heart failure: insights from the AFFIRM-AHF trial.

In AFFIRM-AHF, intravenous ferric carboxymaltose (FCM) reduced heart failure (HF) hospitalisations and improved quality of life versus placebo in iron-deficient patients stabilised after an acute HF episode. This analysis explored the effects of FCM versus placebo in patients with ischaemic and non-ischaemic HF aetiology. We included 1082 patients from AFFIRM-AHF: 590 with ischaemic HF (defined as investigator-reported ischaemic HF aetiology and/or prior acute myocardial infarction and/or prior coronary revascularisation) and 492 with non-ischaemic HF. The prevalences of male sex, comorbidities, and history of HF were higher in the ischaemic versus non-ischaemic HF subgroup. Annualised event rates for the primary composite outcome of total HF hospitalisations and cardiovascular death with FCM versus placebo were 65.3 versus 100.6 per 100 patient-years in the ischaemic HF subgroup (rate ratio [RR] 0.65, 95% confidence interval [CI] 0.47-0.89, p=0.007) and 58.3 versus 52.5 in the non-ischaemic HF subgroup (RR 1.11, 95% CI 0.75-1.66, p=0.60) (pinteraction =0.039). An interaction between HF aetiology and treatment effect was also observed for the secondary outcome of total HF hospitalisations (pinteraction =0.038). A nominal increase in quality of life, assessed using the 12-item Kansas City Cardiomyopathy Questionnaire, was observed with FCM versus placebo, within each subgroup. Heart failure hospitalisations and cardiovascular deaths occurred at a higher rate in patients with ishaemic versus those with non-ischaemic HF and were reduced by FCM versus placebo only in ischaemic patients. Further studies are needed to assess the role of aetiology in FCM efficacy.

0506 Clinical efficacy of intravenous ferric carboxymaltose for restless legs symptoms and low serum ferritin in children with autism spectrum disorder

Abstract Introduction Restless legs syndrome (RLS) may be underdiagnosed in children with autism spectrum disorder (ASD) due to difficulty expressing the symptoms in their own words. In addition, administration of oral iron may be particularly difficult in ASD children. Methods Retrospective case series of children with ASD, restless legs (RL) symptoms, and serum ferritin &amp;lt;30 μg/L treated with intravenous (IV) ferric carboxymaltose (FCM). Patients received a single dose of IV FCM, 15 mg/kg if weighting &amp;lt;50 kg or 750 mg if weighting &amp;gt;50 kg. Data collected included presenting symptoms, serum ferritin, iron profile, and Clinical Global Impression Scale (CGI-Severity pre-infusion and CGI-Improvement post-infusion). Results Nineteen subjects, 4-11 years old (12 male, median age 6, interquartile range (IQR) were included. Thirteen children took melatonin, median dose 3 mg (IQR 1-6). Full RLS diagnostic criteria were identified in 6 verbal children (31.6%). RL symptoms in the 13 other children occurred at night and began or worsened during periods of rest or inactivity and included: need for a parent to rub or massage legs (5), fidgeting (2), wiggling (2), kicking (2), pacing (1), and discomfort (1), but improvement of symptoms with movement was difficult to determine. Baseline median values were ferritin 10 µg/L (IQR 10-16), iron 66.5 μg/dL (IQR 57-96), TIBC 382 μg/dL (IQR 360-411) and transferrin 19 mg/dL (IQR 14-28). Median CGI-S was 4 (moderate symptoms) (IQR 3-4). After IV FCM all measures improved and were statistically significant at the Wilcoxon test for paired datasets. Median ferritin was 68 µg/L (IQR 62.5-109, p&amp;lt;0.00045). The median CGI-I was 1 (very much improved) (IQR 1-2). All children meeting full RLS criteria improved. Three children in the RL symptom group did not improve. Children meeting the full RLS criteria had lower baseline ferritin levels than those with a suspected diagnosis (9 µg/L, IQR 9-10 vs. 13 µg/L, IQR 10-16, Mann-Whitney test p&amp;lt;0.045). Conclusion The majority of children (84.2%) with ASD and RL symptoms had clinical improvement after IV FCM. All serum iron parameters improved significantly after a single IV infusion. Support (If Any) None

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

Efficacy of intravenous ferric carboxymaltose for iron deficiency following acute heart failure (AHF) in patients with previously diagnosed HF: a subgroup analysis of AFFIRM-AHF

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Vifor Pharma OnBehalf The AFFIRM-AHF Investigators Introduction AFFIRM-AHF is the first randomised clinical trial to evaluate the effect of intravenous ferric carboxymaltose (IV FCM) (vs placebo) on morbidity and mortality in patients with an episode of acute heart failure (HF) and concomitant iron deficiency. Purpose To determine the effect of FCM versus placebo on efficacy outcomes in the subgroup of the AFFIRM-AHF cohort with a documented history of HF. Methods This subgroup analysis evaluated patients previously diagnosed with HF. Primary outcome was a composite of total HF hospitalisations and CV death. Secondary outcomes included total HF hospitalisations, CV death, time to first HF hospitalisation or CV death, composite of total CV hospitalisations and CV death, and days lost due to HF hospitalisations or CV death. All outcomes were evaluated up to 52 weeks post-randomisation. Results In AFFIRM-AHF, 73% and 70% of patients randomly assigned to FCM and placebo, respectively, had a documented history of HF. Baseline demographics and clinical characteristics were comparable between treatment groups for this subgroup. There were significantly fewer primary events in patients assigned to FCM compared to placebo: 249 vs 336, respectively (rate ratio [RR] 0.72, 95% CI: 0.55–0.95; p = 0.022). 186 total HF hospitalisations occurred in FCM group and 267 in placebo (RR 0.67, 95% CI: 0.52–0.88; p = 0.004). The composite of first HF hospitalisation or CV death occurred in 149 (37%) assigned FCM and in 179 (44%) patients assigned placebo (hazard ratio [HR] 0·76, 95% CI: 0·61–0·95; p = 0·014). Conclusion In patients with a documented history of HF and iron deficiency who were stabilised after an episode of AHF, treatment with FCM significantly reduced the risk of a composite of total HF hospitalisation and CV death. Primary and Secondary outcomesFCM (n = 405)Placebo (n = 385)RR or HR (95% CI)P valueNo. of eventsRate per 100 patient-yrNo. of eventsRate per 100 patient-yrPrimary outcomeTotal HF hospitalisations and CV death24971.85336101.3RR: 0.72 (0.55-0.95)0.022Secondary outcomesTotal CV hospitalisationsand CV death30888.87401120.57RR: 0.74 (0.58-0.95)0.020Time to CV death63346.5568332.58HR: 0.91 (0.65-1.29)0.602Total HF hospitalisations18653.6726780.28RR: 0.67 (0.52-0.88)0.004Time to first HF hospitalisation or CV death149291.76179257.93HR: 0.76 (0.61-0.95)0.014Days lost due to HF hospitalisation and CV death4.5*526.328.3*955.55RR: 0.58 (0.38-0.90)0.015*Data point is the mean number of days lost per subject.

Comparative study of efficacy of intravenous iron sucrose versus ferric carboxymaltose in the treatment of iron deficiency anaemia

Background: Iron deficiency anaemia (IDA) is a common haematological complication with potentially serious clinical consequences that may require intravenous iron therapy. Parenteral iron therapy results faster and higher replenishment of iron stores and correction of Haemoglobin (Hb) levels with better compliance. The study was to compare the efficacy of intravenous ferric carboxymaltose with intravenous iron sucrose to treat iron deficiency anaemia. Methods: 188 patients were included in the study. 100 patients were given iron sucrose. After a 25 mg test dose on the first infusion only, this was given at a dose of 300 mg by intravenous infusion diluted in 100 ml of normal saline, every alternate day. 88 patients were treated with ferric carboxymaltose at a dose of 500 mg diluted in 100 ml of normal saline by intravenous infusion. Hb level and serum Ferritin of both groups were done before iron therapy and 3 weeks after iron therapy. Results: The mean±SD rise of haemoglobin concentration 3 weeks after iron therapy in iron sucrose group was 11.0±0.61 g/dL, while in ferric carboxymaltose group was 11.2±0.64 g/dL. The mean±SD ferritin 3 weeks after iron therapy in iron sucrose group was 76.0±14.28 ng/mL, while in ferric carboxymaltose group was 80.0±15.16 ng/mL. No serious adverse events were reported in either the ferric carboxymaltose group or iron sucrose group. Conclusions: Ferric carboxymaltose causes higher rise in Hb level as compared to parenteral iron sucrose.

Efficacy of Intravenous Ferric Carboxymaltose in Patients with Acute Post-Operative Anemia after Colorectal Cancer Surgery

Young Ju Oh, M.D., Dae Hee Pyo, M.D., Jung Kyong Shin, M.D., Yoon Ah Park, M.D., Jung Wook Huh, M.D., Hee Cheol Kim, M.D., Seong Hyeon Yun, M.D., Woo Yong Lee, M.D., Yong Beom Cho, M.D., Ph.D.. Surg Metab Nutr 2020;11:61-5. https://doi.org/10.18858/smn.2020.11.2.61

Study of management of postpartum anemia with inj ferric carboxymaltose

Study of management of postpartum anemia with inj ferric carboxymaltose - IJOGR- Print ISSN No: - 2394-2746 Online ISSN No:- 2394-2754 Article DOI No:- 10.18231/j.ijogr.2019.079, Indian Journal of Obstetrics and Gynecology Research-Indian J Obstet Gynecol Res

Safety and efficacy of intravenous ferric carboxymaltose in Japanese patients with iron-deficiency anemia caused by digestive diseases: an open-label, single-arm study

Iron-deficiency anemia (IDA) accounts for majority of anemia. Although iron replacement therapy is effective, in Japan, conventional iron formulations have disadvantages such as gastrointestinal side effects for oral formulations and issues of frequent administration for intravenous (IV) formulations. Ferric carboxymaltose (FCM), which overcomes these limitations, is widely used as an IV iron source overseas. In this multi-center, open-label, single-arm study, we investigated the safety and efficacy of FCM up to 12 weeks after the start of administration in patients with IDA caused by digestive diseases. Thirty-nine patients diagnosed with IDA based on hemoglobin and serum ferritin levels were included. Eligible subjects were administered FCM until the total calculated iron dose (1000 or 1500mg) was achieved over intervals of at least 1 week. A single iron dose was 500mg. In the full analysis set (n = 39), the incidence of adverse events and adverse drug reactions was 71.8 and 48.7%, respectively. All events were as expected from the safety profile of IV iron. The mean change from baseline (10.39g/dL) to the highest observed hemoglobin level was 3.31g/dL. These results indicate the safety and efficacy of FCM for treating IDA caused by digestive diseases in Japanese patients.

Intravenous Iron Treatment in Pregnancy: Ferric Carboxymaltose for Correction of Iron Deficiency Anaemia

Iron deficiency is the most common nutritional deficiency state of women in childbearing age. Peri-partum iron deficiency anaemia (IDA) is associated with significant maternal, fetal and infant morbidity. An effective management is needed to prevent adverse outcomes. Current options for treatment are limited; these include oral iron supplements, which are usually ineffective and poorly tolerated, and whole blood transfusion, which carries an inherent risk, should be avoided during pregnancy. Intravenous ferric carboxymaltose is a new treatment option and it is better tolerated with a good result. The study was designed to assess the safety and efficacy of intravenous ferric carboxymaltose for correction of IDA in pregnant women in third trimester. It was a prospective study; 260 anaemic pregnant women received Injection ferric carboxymaltose, as a total dose of 500-1000 mg between 28 to 36 weeks of pregnancy. Safety was assessed by analyzing adverse drug reactions. Ferric carboxy maltose significantly increased Hb level (p&lt;0.001) in all women in this study group. Increased Hb value was observed 3-4 weeks after infusion. None of the women felt worse. No serious adverse effects were found and minor side effects occurred in 34(13%) patients.Our study revealed that the Hb level increased significantly, was well tolerated and without significant side effects.Faridpur Med. Coll. J. Jul 2017;12(2): 54-57

Role of Intravenous Ferric Carboxy-maltose in Pregnant Women with Iron Deficiency Anaemia.

Iron deficiency is a common nutritional deficiency amongst women of childbearing age. Peri-partum iron deficiency anaemia is associated with significant maternal, foetal and infant morbidity. Current options for treatment include oral iron, which can be ineffective and poorly tolerated, and red blood cell transfusions, which carry an inherent risk and should be avoided. Ferric carboxymaltose is a modern treatment option. The study was designed to assess the safety and efficacy of intravenous ferric carboxymaltose for correction of iron deficiency anaemia in pregnant women. A prospective study was conducted at Institute of Kidney Disease and Research Centre, Ahmedabad from January 2014 to December 2016. Antenatal women (108) with iron deficiency anaemia were the study subjects. Socio-demographic profile was recorded and anaemia was assessed based on recent haemoglobin reports. Iron deficiency was diagnosed on basis of serum ferritin value. Intravenous ferric carboxymaltose as per total correction dose (maximum 1500mg) was administered to all women; the improvement in haemoglobin levels were assessed after 3 weeks of total dose infusion. Most of the women(n= 45, 41.7%), were in the age group of 27-30 years. Most of the women (n = 64, 59.3%) had moderate anaemia as per WHO guidelines. Mean haemoglobin levels significantly increased over a period of 3 weeks after Ferric carboxymaltose administrationand no serious life threatening adverse events were observed. Intravenous ferric carboxymaltose was safe and effective in pregnent women with iron deficiency anaemia.

Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia.

Objective. To evaluate safety and efficacy of intravenous ferric carboxymaltose (FCM) versus standard medical care (SMC) for iron-deficiency anemia (IDA) in postpartum women and women with heavy menstrual bleeding. Study Design. This open-label, multicenter study randomized women with IDA (hemoglobin ≤ 11.0 g/dL) to single doses of FCM (15 mg/kg [maximum 1000 mg]) or SMC (this treatment was determined by the investigator and there may have been no treatment). Safety data (primary outcome) were collected for 30 days. Results. Of 2045 subjects enrolled (FCM: n = 1023; SMC: n = 1022), 996 received FCM and 1022 received SMC. At least 1 serious adverse event (AE) was reported by 0.6% and 2.2% of subjects in the FCM and SMC groups, respectively; none were considered treatment related. The difference in serious AEs was primarily due to higher rates of uterine leiomyoma, uterine hemorrhage, and menorrhagia in SMC subjects with heavy menstrual bleeding. Common AEs were generally predictable, with higher rates of infusion site reactions in FCM subjects and gastrointestinal AEs in SMC subjects. Mean hemoglobin increases were greater in the FCM group than the SMC group. Conclusion. FCM was well tolerated and effectively increased mean hemoglobin levels in postpartum women or women with heavy menstrual bleeding and IDA. This trial is registered with ClinicalTrials.gov, NCT00548860.

Efficacy and Safety of Intravenous Ferric Carboxymaltose in Geriatric Inpatients at a German Tertiary University Teaching Hospital: A Retrospective Observational Cohort Study of Clinical Practice.

Current iron supplementation practice in geriatric patients is erratic and lacks evidence-based recommendations. Despite potential benefits in this population, intravenous iron supplementation is often withheld due to concerns regarding pharmacy expense, perceived safety issues, and doubts regarding efficacy in elderly patients. This retrospective, observational cohort study aimed to evaluate the safety and efficacy of intravenous ferric carboxymaltose (FCM, Ferinject) in patients aged >75 years with iron deficiency anaemia (IDA). Within a twelve-month data extraction period, the charts of 405 hospitalised patients aged 65–101 years were retrospectively analysed for IDA, defined according to WHO criteria for anaemia (haemoglobin: <13.0 g/dL (m)/<12.0 g/dL (f)) in conjunction with transferrin saturation <20%. Of 128 IDA patients screened, 51 (39.8%) received intravenous iron. 38 patient charts were analysed. Mean cumulative dose of intravenous FCM was 784.4 ± 271.7 mg iron (1–3 infusions). 18 patients (47%) fulfilled treatment response criteria (≥1.0 g/dL increase in haemoglobin between baseline and hospital discharge). AEs were mild/moderate, most commonly transient increases of liver enzymes (n = 5/13.2%). AE incidence was comparable with that observed in patients <75 years. No serious AEs were observed. Ferric carboxymaltose was well tolerated and effective for correction of Hb levels and iron stores in this cohort of IDA patients aged over 75 years.

Safety and Efficacy of Ferric Carboxymaltose in Anemic Pregnant Women: A Retrospective Case Control Study.

Background. Anemia during pregnancy is commonly caused by iron deficiency and can have severe consequences for both the mother and the developing fetus. The aim of this retrospective study was to assess the safety and efficacy of intravenous ferric carboxymaltose (FCM) in pregnant women. Methods. All women treated with FCM for anemia during pregnancy between 2010 and 2012 at our institution were included. A matched control group was selected, including women who either were nonanemic or had anemia but were not considered for intravenous iron. Main outcome measures were maternal safety and pregnancy outcomes. Results. The study included 128 patients (FCM: 64; control: 64). Median FCM dose was 1000 mg and median gestational age at the time of first treatment was 34 weeks and 6 days. Median Hb increased from 8.4 g/dL (interquartile range 7.7; 8.9 g/dL) at the first FCM administration to 10.7 g/dL (9.8; 11.5 g/dL; n = 46 with available Hb at delivery) at the time of delivery, achieving levels similar to those in the control group (10.8 g/dL [9.8; 11.8 g/dL; n = 48]). No treatment-related adverse events were reported and no statistically significant differences in pregnancy outcomes were observed between groups. Conclusions. Within the limitations of this case control study, FCM was a safe and efficient treatment of anemia during pregnancy.

Treatment of iron deficiency with intravenous ferric carboxymaltose in general practice: a retrospective database study.

BackgroundIron deficiency is a frequent problem in general practice. Oral supplementation may in some cases not be well tolerated or not be efficient. Intravenous ferric carboxymaltose may be an alternative for iron supplementation in general practice. The aim of the present study was to analyze the indications for and the efficacy of intravenous ferric carboxymaltose in a primary care center.MethodsWe retropectively analyzed electronic data from 173 patients given intravenous ferric carboxymaltose between 2011 and 2013 in primary care center with 18 GPs in Bern, Switzerland.ResultsOf all patients, 34% were treated intravenously due to an inappropriate increase in ferritin levels after oral therapy, 24% had side effects from oral treatment, 10% were treated intravenously due to the patients explicit wish, and in 39% of all cases, no obvious reason of intravenous instead of oral treatment could be found. Intravenous ferric carboxymaltose led to a significant increase in hemoglobin and serum ferritin levels. Side effects of intravenous treatment were found in 2% of all cases.ConclusionWe conclude that treatment with intravenous ferric carboxymaltose is an efficient alternative for patients with iron deficiency in general practice, when oral products are not well tolarated or effective. As treatment with iron carboxymaltose is more expensive and potentially dangerous due to side effects, the indication should be placed with (more) care.

Safety and Efficacy of Intravenous Ferric Carboxymaltose (750 mg) in the Treatment of Iron Deficiency Anemia: Two Randomized, Controlled Trials

Background. Iron deficiency anemia (IDA) is a common hematological complication with potentially serious clinical consequences that may require intravenous iron therapy. Ferric carboxymaltose (FCM) is a stable, nondextran iron formulation administered intravenously in large single doses to treat IDA. Objective. Two open-label, randomized, placebo-controlled trials evaluated safety of multiple or single 750 mg FCM doses compared to standard medical care (SMC) in IDA patients. Secondary endpoints were improvements in hemoglobin and iron indices. Design and Patients. Adults with hemoglobin ≤12 g/dL, ferritin ≤100 or ≤300 ng/mL with transferrin saturation ≤30% were randomized to receive single (n = 366) or weekly (n = 343) FCM or SMC (n = 360 and n = 366). Results. Significantly greater (P ≤ 0.001) increases in hemoglobin and iron indices occurred in FCM groups versus SMC. In the multidose study, up to two infusions of FCM were needed to reach target iron levels versus 3–5 of intravenous iron comparators. FCM and SMC groups had similar incidences and types of adverse events and serious adverse events. Transient hypophosphatemia not associated with adverse events or clinical sequelae occurred in the FCM groups. Conclusion. Intravenous FCM is safe, well tolerated, and associated with improvements in hemoglobin and iron indices comparable to SMC when administered in single doses of up to 750 mg at a rate of 100 mg/min. Fewer FCM infusions were required to reach target iron levels compared to other intravenous iron preparations.

The safety and efficacy of intravenous ferric carboxymaltose in anaemic patients undergoing haemodialysis: a multi-centre, open-label, clinical study

Background. Patients with chronic kidney disease (CKD) often present with iron depletion and iron deficiency anaemia (IDA) because of frequent blood (and iron) loss. Therapy consists of repletion of iron stores and intravenous (i.v.) iron has become the standard care in this setting. However, older i.v. iron preparations have their limitations. This study primarily investigated the safety, and also the efficacy, of ferric carboxymaltose (FCM), a next-generation i.v. iron formulation, given as a bolus–push injection in patients with CKD undergoing maintenance haemodialysis (HD).Methods. Patients (aged 18–65 years) with IDA undergoing HD received 100–200 mg of iron as FCM via an i.v. bolus–push injection into the HD venous line, two to three times weekly for ≤6 weeks. Safety assessments included incidence of adverse events (AEs). Treatment responders were patients attaining ≥1.0 g/dl increase in haemoglobin (Hb) from baseline at any time during the study. Enrolled patients (safety population) receiving ≥1 dose of study medication were included in the efficacy analyses [intent-to-treat (ITT) population].Results. Of 163 patients enrolled, 150 (92%) completed the study. The mean ± SD total cumulative dose of iron as FCM administered was 2133.3 ± 57.7 mg. In total, 193 AEs were reported in 89 out of 163 (54.6%) patients. Almost three-quarters of patients (73.6%) received erythropoiesis-stimulating agents (ESAs), but the dose remained stable during the study. Serious AEs occurred in 12 out of 163 (7.4%) patients and two patients died; none of these was considered by the investigator to be related to the study medication. Only five out of 163 (3.1%) patients discontinued study medication due to an AE. Overall, 100 out of 162 (61.7%; ITT population) patients were treatment responders, and mean Hb levels increased from 9.1 ± 1.30 g/dl at baseline to 10.3 ± 1.63 g/dl at follow-up.Conclusions. FCM is well-tolerated and effective in the correction of Hb levels and iron stores in patients with IDA undergoing HD. As changes in anaemia treatment other than i.v. FCM (e.g. increased ESA doses) were not permitted during the study, the clinically relevant increase in Hb in the majority of patients can be solely attributed to efficient iron utilization. The incidence of AEs was as expected for this population.