Polymaltose Complex Research Articles

Oral Iron-Hydroxide Polymaltose Complex Versus Sucrosomial Iron for Children with Iron Deficiency with or without Anemia: A Clinical Trial with Emphasis on Intestinal Inflammation.

Iron deficiency anemia (IDA) is a major public health problem among children worldwide. Iron deficiency without anemia (IDWA) is at least twice as common as IDA. Some studies propose that oral iron fortification can modify the infant's gut microbiome, leading to intestinal inflammation. To determine whether oral iron therapy can lead to intestinal inflammation in children with IDA or IDWA. Fifty-six patients aged 6 months to 16 years (median age 7.6 years) with IDA or IDWA were randomly assigned to receive either iron (III)-hydroxide polymaltose complex (IPC) 5 mg/kg once daily (maximum dose 100 mg) or sucrosomial iron (SI)1.4 mg/kg once daily (maximum dose 29.4 mg). Safety and efficacy were studied after 30 and 90 days of treatment. In addition, fecal calprotectin as a marker of intestinal inflammation was measured simultaneously and compared to results obtained before therapy. A significant increase in serum ferritin was noted in both groups as the median ferritin level at baseline was 6.7 μg/L in the IPC group and 6.6 μg/L in the SI group, increasing to 15.9 μg/L and 12.1 μg/L respectively, after 90 days of treatment. However, there was no significant change in fecal calprotectin in either group. In addition, no differences in the trend over time were observed between the two groups regarding fecal calprotectin, serum ferritin, and hemoglobin. IPC and SI were equally effective in treating IDA and IDWA. At the recommended doses, oral iron therapy does not seem to induce intestinal inflammation.

Effect of Iron Polymaltose Complex Prophylaxis on Frequency of Iron Deficiency and Iron Deficiency Anemia.

To evaluate the effectiveness of national iron prophylaxis policy in 9-12 mo-old infants in Turkey. This study was planned as a cross-sectional study, and it included healthy infants aged 9 to 12 mo who presented to the pediatric outpatient clinic for routine check-ups. Parents were interviewed to identify risk factors for iron deficiency (ID) and gather information on Fe+3- iron polymaltose complex (IPC) prophylaxis usage. Blood samples were collected for hemogram and ferritin analysis. Multiple logistic regression analyses were conducted to determine risk factors for ID and iron deficiency anemia (IDA). The study included 317 infants. In the non-prophylaxis group, the frequency of IDA was 31.1%, compared to 13.4% in the regular prophylaxis group. Iron deficiency was detected in 25% of individuals receiving regular prophylaxis and 13.1% of those without prophylaxis. The risk factors for IDA were insufficient iron diets (OR 2.45, 95% CI: 1.35-4.45) and not receiving Fe+3 - IPC prophylaxis (OR 2.57, 95% CI: 1.24-5.31). The relationship between Fe+3-IPC prophylaxis and ID did not reach statistical significance (p = 0.253). Fe+3- IPC prophylaxis is associated with a lower risk of iron deficiency anemia, but not iron deficiency.

Pica sebagai Manifestasi Anemia Defisiensi Besi: Suatu Laporan Kasus

Prevalence of anemia in Indonesia based on Basic Health Research (2018) was 23.7%. Symptoms of iron deficiency anemia were pallor, malaise, palpitation, shortness of breath, headache, sore tongue. But sometimes can be found abnormal behavior in the form of PICA. This article reports on a-52-year-old man who sought medical treatment and was diagnosed with iron deficiency anemia with pica manifestation. The pica manifestation was characterized by a repeated desire to consume raw rice due to bleeding from hemorrhoids. Patient was given oral iron replacement therapy contain 100 mg of Fe (III) hydroxide polymaltose complex and folic acid 0.35 mg alternating with vitamin C 500 mg daily. Total iron daily dose given were 200 mg, divided in two doses. The patient received dietary education and was advised to consult a Gastroenterohepatology Subspecialist for the management of hemorrhoids, but it has not been done yet. The desire for raw rice consumption disappeared and the hemoglobin level increased to 12.4 g/dL after six weeks of therapy. The patient continued to take iron supplements until January 2023 but did not have follow-up visits to the clinic. In January 2023, the patient underwent hemorrhoid surgery due to bleeding accompanied by and a non-reducible lump that had been present for three days. Iron supplements continued for one month post-operation and then discontinued. The latest hemoglobin level was 15.3 g/dL without iron supplements. The symptoms of pica in this patient disappeared along with an increased hemoglobin level, and the management of severe anemia in this patient showed an adequate response. Bleeding has never occurred again after the surgery. Curative measures for hemorrhoidal bleeding are crucial, while iron supplementation is only a supportive therapy.

Comparison of the Prophylactic Use of Iron Polymaltose Complex and Ferrous Sulfate Iron Preparations in Terms of Efficacy and Side Effect Profile in Pregnant Women

Comparison of the Prophylactic Use of Iron Polymaltose Complex and Ferrous Sulfate Iron Preparations in Terms of Efficacy and Side Effect Profile in Pregnant Women

Comparison of Ferrous Sulphate Versus Iron Polymaltose Complex in the Treatment of Iron Deficiency Anemia in Children

Objective: To compare the efficacy of ferrous sulphate versus iron Polymaltose complex (IPC) in the treatment of iron deficiency anemia (IDA) in children. Study Design: Randomized controlled trial. Place and Duration: Department of Pediatrics, Combined Military Hospital, Kharian Pakistan from Jan 2019 to Mar 2020. Methodology: A total of 150 children with IDA were included. At baseline, blood sample was obtained for assessment of hemoglobin level. Then children were randomly divided in two groups. In Group-A (n=75), patients were given ferrous sulphate while in In Group-B (n=75), IPC was given. After 12-weeks of treatment, hemoglobin level was assessed. Efficacy was labeled as “yes” if there was 2 g/dl hemoglobin improvement. Results: In a total of 150 children, the mean age in Group-A was 6.56±2.33 years and 6.05±2.78 years in Group-B. In group A, there were 37 (49.3%) males and 38 (50.7%) females while in Group-B there were 35 (46.7%) males and 40 (53.3%) females. At baseline in group A, the mean hemoglobin level was 6.07±1.12 g/dl while in group B, it was 6.16±1.14 g/dl. After 12-weeks, in Group-A the mean hemoglobin level was 9.44±1.61 g/dl whereas in Group-B, it was 8.83±2.01 g/dl (p=0.0420). There was insignificant difference observed for efficacy in both groups (p-value = 0.051). Practical Implications: Both IPC and ferrous sulphate resulted in significant rise in hemoglobin levels but ferrous sulphate showed better results in comparison to IPC. Conclusion: Although in comparison to IPC, ferrous sulphate resulted in significantly better rise in hemoglobin levels among children with IDA, but overall efficacy between the two studied drugs was relatively similar. Keywords: Ferrous sulphate, iron Polymaltose complex, iron deficiency anemia.

Results of Randomized Comparative Efficacy Study of Iron Deficiency Anemia Management in Children with Iron III Hydroxide Polymaltose Complex and Iron Sulfate

Background. The guidelines on selection between iron preparations, iron sulfate (IS) and iron III hydroxide polymaltose complex (HPC), for iron deficiency anemia (IDA) management in pediatrics are contradictory. Objective. The aim of the study is to compare efficacy and safety of iron (III) HPC and IS for IDA treatment in children. Materials and methods. Randomization of children (aged from 1 month to 18 years) with IDA into 2 therapeutic groups was implemented in 2019-2020. on pediatric districts of children’s city outpatient's clinic: IS dosage of 3 mg/kg/day and iron (III) HPC dosage of 5 mg/kg/day. Hemogram monitoring was performed every 14 days. The efficacy was compared according to the rate of Hb level increase, erythrocytes indices, and serum ferritin (SF) level at the recorded moment of Hb normalization. For the safety — the rate of adverse effects. Results. 65 children with IDA were included in the study and randomized into 2 groups, the median age was 2.3 years (1st; 3rd quartile = 1.1; 4.3). Hb level increase was comparable in both groups (0.34 (0.23; 0.48) g/L/day and 0.24 (0.21; 0.30) g/L/day, р = 0.891). IS is more effective than iron (III) HPC in terms of average red blood cell volume by the time of Hb normalization (83.5 (80.0; 86.7) fl against 80.7 (79.0; 82.0) fl, р = 0.006), and mean cellular hemoglobin content (28.9 (SD = 2.0) pg against 27.4 (SD = 1.8) pg, р = 0.004). The timing of SF levels normalization did not differ. Adverse effects to iron III HPC treatment occurred 5.5 times more frequently than to IS (p = 0.0001). Conclusion. The efficacy of IS and iron III HPC at standard doses is comparable. The advantage in tolerability and recovery of erythrocytic indices justifies the feasibility of using IS preparations in the first line of treatment for children with IDA.

Iron Supplementation in Anemic Pregnant Women: A Comparison of Different Prescription Options in Pakistan

Background & objectives: Many pregnant women in Pakistan have iron deficiency anemia (IDA), a dietary deficit. It affects both the mother's and the foetal' health. Oral iron supplementation usually relieves IDA symptoms. Oral iron supplements are hazardous to the GI mucosa, and sensitivity is common. Poor therapeutic compliance leads to treatment failure. Ferrous ascorbate (FeA) and iron hydroxide polymaltose complex (IPC) reportedly improve gastrointestinal discomfort and increase patient compliance compared to ferrous sulphate (FS). These preparations reportedly improve hemoglobin levels and iron stores more quickly than FS. This analysis compared FS's efficacy and safety to IPC and FeA. Place of Study: Rashid Latif Medical College Lahore Duration of Study: February 2019 and October 2021 Methods: It was a randomized, parallel, open label, investigation among pregnant women of gestational age from 10 to 28 weeks with moderate anemia. Patients were randomly selected to receive either FS, IPC or FeA. They were then followed up for 3 months to look for improvement in the hemoglobin levels and other hematological indicators or any adverse drug response. Results: With the exception of 3 months, when the FeA group had a significantly higher hemoglobin level in comparison to the FS group (P <0.05), the hemoglobin levels were comparable across the three groups. The overall risk profiles for side effects were likewise equal across the research groups, with the exception of epigastric discomfort, which was more frequently reported in the FS group. Conclusions: The findings of the study indicated that FS, IPC, and FeA all have an efficacy and safety profile in the treatment of IDA associated with pregnancy that is comparable to one another. Keywords Anemia, ferrous ascorbate , ferrous sulphate ,iron hydroxide polymaltose ,pregnancy

EFFECT OF IRON (III)-HYDROXIDE POLYMALTOSE COMPLEX ON ANEMIA: A LITERATURE STUDY

Health is an important thing to be maintained in life. In the development of this era, many people, especially teenagers, do not pay attention to the intake of nutrients, iron, and protein that enter the body causing disease. One of the diseases that can be caused is anemia. According to the National Institute of Health (NIH) the cause of anemia can be caused by a lack of iron, vitamins, or chronic disease. In Indonesia, the occurence of anemia is fairly high. still quite high. To overcome anemia, iron complex compounds can be used because one of the things that causes anemia is a lack of iron in the body. This study aims to describe the application of iron (III)-hydroxide polymaltose complex as an effective compound in overcoming of iron deficiency anemia.This study was compiled from the online literature of local and international journals using secondary data that had been screened based on keywords. The results of the study concluded that iron (III)-Hydroxide Polymaltose Complex Compounds can be used to treat anemia.This literature study covers recently published (year > 2000) reports on iron (III)-Hydroxide Polymaltose Complex Compounds in overcoming the health problem of anemia.

Use of oral iron in managing iron deficiency anemia in children with intestinal failure

Background & ObjectivesAs intestinal failure (IF) inhibits the digestive system from absorbing nutrients, total parenteral nutrition (TPN) is required to provide all of a person's nutritional demands. In children with malabsorptive conditions like IF, iron deficiency anemia (IDA) is common. This study used a quasi-experimental approach to assess the efficacy and safety of oral iron therapy in treating IDA in TPN-dependent children with IF. Materials and MethodsSixteen pediatric patients with an ongoing history of IF, TPN dependency, and iron deficiency anemia were enrolled and given an oral iron syrup dose of ferric hydroxide polymaltose complex (6 mg/kg/day in 2–3 separate doses of elemental iron) after receiving ethical approval and parental consent. Blood tests were done to measure serum iron, ferritin, complete iron-binding capacity [TIBC], transferrin saturation [TSAT], and hemoglobin (Hb) level at the time of inclusion (T0), 14 (T14), and 30 days after treatment (T30). ResultsThe mean age was 7.13 (±1.99) and female were 12 (75%). No remarkable change in Hb level was noted in the first and second subsequent follow-ups, notwithstanding, the normal estimation of the serum ferritin level significantly increased during the first follow-up (on fourteenth day) which further enhanced by second follow-up (30th day). The aggregate of the total iron binding capacity (TIBC) declined during the course of oral iron therapy with a reduction in transferrin saturation. Interpretation & ConclusionThe data suggest that oral iron therapy is unsuccessful in the treatment of IDA in children with IF. There is no substantial improvement in hemoglobin level or iron profile aside from serum ferritin. In order to avoid using parenteral iron in IF patients, an additional supportive system is needed to aid in the integration of oral iron therapy.

Protective effect of Beta vulgaris roots supplementation on anemic phenylhydrazine-intoxicated rats.

Anemia is a public health problem that affects many people worldwide. Beetroot (Beta vulgaris) is a plant supposed to have many healthy features. The present study was done to evaluate the anti-anemic effect of beetroot supplement on anemia induced by phenylhydrazine in albino rats. Fifty rats were randomly divided into five equal groups. The control group was kept normal rats. In the second group, anemia was induced in rats by intraperitoneal injection of phenylhydrazine at 60 mg/kg in 3 divided doses daily, for 3 consecutive days. The last three groups received phenylhydrazine as the anemic group. Then, the third group received beetroot extract in dose 200 mg/kg for 24 days. The fourth group received beetroot powder in dose 1000 mg/kg for 24 days. The last group received iron (III) hydroxide polymaltose complex in dose 5mg/kg for 24 days. Our results showed that hemolytic anemia induced by phenylhydrazine in rats caused alteration in the blood picture, iron indices, serum biochemical parameters, antioxidant biomarkers, and histopathological picture. However, the supplementation with beetroot ameliorated these alterations, especially beetroot powder which showed powerful health effects compared to beetroot extract and iron preparation.

Lactoferrin versus iron hydroxide polymaltose complex for the treatment of iron deficiency anemia in children with cerebral palsy: a randomized controlled trial.

Iron deficiency anemia (IDA) is common among children with cerebral palsy (CP), and studies on the efficacy of lactoferrin (Lf) in the treatment of IDA are limited. This study aimed to compare the efficacy of Lf with that of iron hydroxide polymaltose complex (IPC) in the treatment of IDA in children with CP. This randomized controlled study, conducted at Alexandria University Children's Hospital, enrolled 70 children aged 1-10 years with CP and IDA; 35 children randomly received IPC, whereas the other 35 received Lf. Four children withdrew from the study; thus, only 66 children were analyzed (32 in the IPC group and 34 in the Lf group). At baseline, the hemoglobin level and other blood parameters were similar between the two intervention groups. After four weeks of treatment, both the IPC and Lf groups showed significant improvements in hemoglobin (Hb), serum ferritin (SF), serum iron, total iron-binding capacity, mean corpuscular volume, and mean corpuscular hemoglobin from baseline. Upon comparing the two treatment groups, adjusted mean Hb and SF changes in the Lf group were significantly higher than that of the IPC group (p =0.001and p= 0.033, respectively), and constipation was less likely to occur in the Lf group than the IPC group (p = 0.049 ).Conclusion: Lactoferrin is effective and superior to IPC as an oral iron replacement therapy in children with CP and IDA, as it has fewer side effects. What is Known: • Lactoferrin (LF) is a natural glycoprotein capable of treating iron deficiency anemia (IDA). • Studies on the efficacy of Lf in the treatment of IDA in children with cerebral palsy (CP) are limited. What is New? • This trial compared the efficacy of Lf and iron hydroxide polymaltose complex (IPC) as treatments of IDA in children with CP. • Lf is effective and even better than IPC as a treatment of IDA in children with CP, as it has fewer side effects.

Interventions for treating iron deficiency anaemia in inflammatory bowel disease.

Interventions for treating iron deficiency anaemia in inflammatory bowel disease.

Comparison of efficacy & safety of iron polymaltose complex & ferrous ascorbate with ferrous sulphate in pregnant women with iron-deficiency anaemia.

Background & objectives:Iron-deficiency anaemia (IDA) is a common nutritional deficiency among pregnant women in India. It has a significant impact on the health of the mother as well as that of the foetus. IDA generally responds well to treatment with oral iron supplementation. However, oral iron supplements are toxic to the gastrointestinal mucosa and intolerance is common, resulting in poor compliance and failure of treatment. The iron salts such as iron hydroxide polymaltose complex (IPC) and ferrous ascorbate (FeA) are claimed to have low gastrointestinal intolerance, therefore better patient compliance than the conventionally used ferrous sulphate (FS). These preparations also claim to increase haemoglobin level faster as well as improve the iron storage better than FS. This study was done to compare the efficacy and safety of FS with IPC and FeA.Methods:It was a randomized, parallel, open label, study among pregnant women of gestational age between 12 to 26 wk with moderate anaemia. Patients were randomly allocated to receive either FS, IPC or FeA. They were then followed up for 90 days to observe for improvement in the haemoglobin levels and other haematological parameters or any adverse drug reaction.Results:The haemoglobin levels were comparable in the three groups except at day 90 when FeA group had significantly higher haemoglobin level as compared to FS group (P<0.05). The overall adverse effect profiles were also comparable among the study groups except epigastric pain which was more commonly reported in the FS group.Interpretation & conclusions:The results of the study showed that FS, IPC and FeA have comparable efficacy and safety profile in the treatment of IDA of pregnancy.

Частота и причины железодефицита у малочисленных народов Севера (ханты и манси), мигрировавших в город и ведущих традиционный образ жизни (стойбища, село), опыт применения препаратов железа

Objective. To study the health status of women from among the small-numbered indigenous peoples of the North (SIPN), including those leading a traditional way of life in camps and rural areas. Patients and methods. Using continuous sampling method, a prospective analysis of complaints, anamnestic, anthropometric, and laboratory data was carried out in female patients from among SIPN (Khanty and Mansi) living in rural areas and camps, as well as in the city of Khanty-Mansiysk. The comparison group consisted of women from the migrant population (Russians) living in the city of Khanty-Mansiysk. Results. The greatest number of health disorders was found among SIPN who migrated to the city in the first and second generations. Overweight was observed in 46.2% of women in this cohort, obesity was diagnosed in 19.2% of women. Heavy and prolonged menstrual bleeding was the main cause of iron deficiency (11.5%) and iron deficiency anemia (IDA) (30.8%) in the group of SIPN living in the city. IDA of mild severity occurred in 19.2% of patients, and of moderate severity – in 11.5%. Conclusion. Iron metabolism disorders were observed in 42.3% of women from among SIPN who migrated to the city. Iron(III)- hydroxide polymaltose complex (Ferrum Lek®), which is used in the complex therapy of gynecological diseases (menstrual disorders) and gastrointestinal diseases, has high efficiency, good tolerability and the least number of adverse effects. This makes it possible to recommend it for the treatment of IDA and for the replenishment of iron stores in women in both SIPN and newcomer populations. Key words: anemia, iron deficiency, female residents of the Khanty-Mansi Autonomous Area-Yugra, small-numbered indigenous peoples of the North (Khanty and Mansi), Ferrum Lek

Анемизирующий синдром у современных женщин — нерешенная мировая проблема. Врачебная тактика

Objective of the Review: To set forth the frequency and prevalence of the anemia syndrome in non-pregnant and pregnant women and approaches to treating this disorder. Key Points: Anemia syndrome is the most common health problem in contemporary women. The leading cause of iron deficiency in women of reproductive age is abnormal uterine bleeding (AUB). Anemia in women significantly reduces their ability to work and quality of life, and increases the rates and severity of complications in pregnant women and parturients. It is also a significant contributor to maternal mortality and fetal and neonatal morbidity. Treating anemia in pregnant women presents certain challenges. In the period between the first trimester and delivery, there is an 8-fold increase in the requirement for iron; therefore, hemoglobin levels return to normal slowly. The active ingredient of Ferrum Lek is a ferric hydroxide polymaltose complex, which is as effective as medications containing ferrous sulfate, but is significantly better tolerated by patients and easier to use. The active transport of iron allows its controlled absorption from the polymaltose complex, minimizing the risk of an increase in serum levels of iron not bound to transferrin. This ensures that this medication is very safe and eliminates the risk of overdose or poisoning. Conclusion: Anemia syndrome is the most common type of homeostatic imbalance in women of reproductive age. It most often results from frequent and abundant uterine bleeding (AUB). Therefore, an obstetrician-gynecologist plays the leading role in identifying menstrual disorders and choosing therapies to reduce blood loss. A gynecologist will also work with an internist (hematologist) in treating iron deficiency anemia. Keywords: anemia syndrome, iron deficiency anemia, abnormal uterine bleeding, ferric hydroxide polymaltose complex.

Iron polymaltose complexes: Could we spot physicochemical differences in medicines sharing the same active pharmaceutical ingredient?

Oral iron therapy can efficaciously treat both iron deficiency and iron deficiency anemia. To overcome the recurrent side effects of iron(II) salts, medicines containing iron(III) such as iron polymaltose complex (IPC) have been introduced in several markets. Despite the claimed improved safety versus iron(II) preparations, divergent evidences are currently available on IPC efficacy. Indeed, the use of either an originator drug or a follow-on version (“similar”) of this medicine might result in different clinical performances. The aim of this work was the pioneer evaluation of physicochemical properties of IPC vs. iron polymaltose complex similars (IPCSs) as nanomedicines. This, to assess the presence of deviations for commercially available products supposedly containing the same active pharmaceutical ingredient and currently considered as generics. Significant differences with respect to size, size distribution, stability and degradation kinetics of the products are reported here. Therapeutic equivalence of IPC and IPCSs is not proven, and new guidelines are needed to determine whether these nanomedicines can be regarded as interchangeable.

Comparison of Therapeutic Efficacy of Ferrous Ascorbate and Iron Polymaltose Complex in Iron Deficiency Anemia in Children: A Randomized Controlled Trial.

To compare the therapeutic efficacy of Ferrous ascorbate (FA) and Iron polymaltose complex (IPC) in Iron deficiency anemia (IDA) in children. A randomized controlled trial (RCT) was conducted at a tertiary care hospital with 125 (1-12 y) children having clinical symptoms and signs of IDA. Participants were randomized into FA group and IPC group. Both the groups received iron salts (FA or IPC) randomly in a dose of 6mg/kg elemental iron for 3 mo and followed up on day 3, day 7, at the end of 1 mo and 3 mo for Hemoglobin (Hb), Mean corpuscular volume (MCV), Red cell distribution width (RDW) and reticulocyte count. Both groups had an improvement in hematological parameters at 3 mo of intervention. The difference in the rise of Hb (g%) at the end of 1 mo in FA group (3.13 ± 1.01) vs. IPC group (2.0 ± 0.85); p = 0.017 and at 3 mo in FA group (4.88 ± 1.28) vs. IPC group (3.33 ± 1.33); p = 0.001 was statistically significant. The difference in the rise of mean Hb was significantly better in FA than the IPC group F [3392] =1.79; p = 0.00 (ANOVA). The difference in the mean increase in MCV (fL) at day 7 in FA group (6.71 ± 8.32) vs. IPC group (2.91 ± 6.16); p = 0.011 and at 1 mo FA group (9.80 ± 8.56) vs. IPC group (5.35 ± 6.11); p = 0.004 was statistically significant. The mean decrease in RDW (%) at 1 mo in FA group (4.23 ± 3.27) vs. IPC group (2.67 ± 1.95); p = 0.005 and at 3 mo in FA group (5.74 ± 3.63) vs. IPC group (4.04 ± 2.17); p = 0.006 was statistically significant. The difference in the rise in mean reticulocyte count at day 3 in FA group (0.88 ± 0.50) vs. IPC group (0.43 ± 1.20); p = 0.017 and at day 7 in FA group (4.00 ± 1.69) vs. IPC group (2.19 ± 1.24); p = 0.001 was statistically significant. F [2294] = 29.2, p = 0.00 (ANOVA). During the study period, the FA group had minor adverse reactions whereas the IPC group had none. Both the iron salts (FA and IPC) used in the treatment of IDA showed statistically significant improvement in the hematological parameters during the 3 mo of intervention. The improvement in hematological parameters was better in FA supplemented patients as compared to IPC.

Effects of 6-months of oral ferrous and ferric supplement therapy in patients who were hospitalized for decompensated chronic heart failure.

ObjectiveAnemia is common in patients with chronic heart failure (CHF). This study aimed to examine the frequency of iron deficiency anemia in patients with CHF. We investigated the effects of oral ferrous or ferric supplementation on prognosis of CHF and quality of life.MethodsA total of 201 patients with chronic decompensated heart failure were enrolled in a 6-month prospective study. Patients were randomly assigned to two groups. Patients in group I (n = 100) received ferrous fumarate and those in group II (n = 101) received ferric hydroxide polymaltose complex. Quality of life was measured by the 6-minute walking test (6MWT).ResultsA total of 49% of the patients had iron-dependent anemia in group I and 53.3% were anemic in group II. In group I, the number of anemic patients was significantly lower at 6 months after admission compared with at initial admission (49% versus 45%). Significant improvements were observed in hemoglobin values, the 6MWT distance, and New York Heart Association class after 6 months in both groups.ConclusionsIron deficiency is a significant comorbidity in CHF, even without anemia. Iron should be replaced orally or intravenously because it significantly improves the quality of life of patients.

Intravenous iron sucrose versus oral iron administration for the postoperative treatment of post-bariatric abdominoplasty anaemia: an open-label, randomised, superiority trial in Brazil

Anaemia and iron deficiency are common after post-bariatric abdominoplasty, which can involve removal of large areas of skin with associated blood loss. Because the oral absorbability of iron is reduced after bariatric surgery (through reduced intake, reduction of gastric acid secretion for conjugation of iron, and separation of the iron-absorptive areas of the duodenum and jejunum), it has been hypothesised that postoperative intravenous iron supplementation might be used to treat anaemia and iron deficiency in patients submitted to post-bariatric plastic surgeries. We aimed to assess whether intravenous iron administered postoperatively in post-bariatric abdominoplasty could result in increased blood haemoglobin concentrations compared with oral iron supplementation. In this open-label, randomised, superiority trial, we recruited women aged 18-55 years undergoing post-bariatric abdominoplasty at two public tertiary referral hospitals in São Paulo, Brazil. Eligible women had been treated for previous obesity with bariatric surgery using the vertical banded gastroplasty technique with Roux-en-Y gastric bypass by laparotomy; had grade III contour deformity via the Pittsburgh rating scale; and had a post-bariatric body-mass index (BMI) lower than 32 kg/m2, with stabilised weight loss for at least 6 months. Women were randomly assigned (1:1) to receive postoperative iron supplementation with two intravenous infusions of 200 mg of iron sucrose (intravenous group) or 100 mg of iron polymaltose complex orally twice a day for 8 weeks (oral group). The primary outcome in both groups was blood haemoglobin concentration at postoperative day 56 after abdominoplasty, with a minimum clinically relevant difference of 1·5 g/dL. Analyses were performed on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT01857011, and the Brazilian Clinical Trials Registry, number RBR-2JGRKQ. The trial is completed. From April 7, 2014, to June 27, 2016, 102 post-bariatric patients were assessed for eligibility. 56 patients were eligible and were randomly assigned, with 28 allocated to each group. Mean baseline haemoglobin concentration was slightly higher in the oral group than in the intravenous group (12·71 g/dL [SD 1·06] vs 12·24 g/L [1·09]), and by post-operative day 56 was 12·54 g/dL (SD 1·18) and 12·80 g/dL (0·81), respectively (mean difference of 0·26 g/dL, 95% CI -0·28 to 0·80; p=0·009 in favour of the intravenous group). The minimum clinically relevant difference in concentrations was not reached. No adverse events were recorded in the intravenous group, whereas in the oral group, constipation was recorded in five (18%) patients, diarrhoea in three (11%), and nausea in one (4%) patient. Postoperative intravenous administration of iron increased haemoglobin concentrations at 56 days post-operatively and reduced iron deficiency, without adverse events. Although superiority of intravenous iron was not shown, intravenous administration might be useful in post-bariatric patients, especially in those who have body-contouring treatment involving a second surgery within a short period of time. Larger trials, and trials using higher intravenous doses of iron, are needed to further assess the potential efficacy and safety of intravenous iron administration after post-bariatric plastic surgery. The São Paulo Research Foundation (FAPESP).

Efficacy, Tolerability, Compliance, and cost of ferrous sulfate versus iron polymaltose complex capsules: a randomized trial in pregnant women with iron deficiency anemia

Aim: The main objective of this trial was to compare the therapeutic efficacy, gastrointestinal and systemic tolerability as well as compliance on oral medicinal iron consumption and total related drugs costs between sustained released ferrous sulphate (SRFS) oral capsules and soft gelatinous capsules of non-ionic ferric (Fe+3) polymaltose complex (IPC) in treating gestational iron deficiency anemia (GIDA) in second (2nd) and early third (3rd) trimester. Patients and Methods: This prospective, open-label, randomized, parallel group, concealed allocation, controlled, multicenter superiority trial was conducted at Benha University Hospital (BUH) and two private clinics in El-Qalubia, Egypt, from October 2016 to December 2017. We screened 500 pregnant women, 310 women were eligible and consented to participate in GIDA trial. All women included were had typical mild or moderate iron deficiency anemia (IDA) as their hemoglobin (HB), and serum ferritin (SF) was ≤ 10.5 or 11 to ≥ 8 gm/dl and ≤ 15 ng/ml respectively. 155 women were allocated to either consume 100mg elemental iron (EI) of dried SRFS (60 capsules of ferroful® / four weeks) in the SRFS arm or 100 mg EI of IPC (28Haemojet® capsules /4weeks) in IPC arm. Main outcomes were the change (Δ) in HB and SF at 4 weeks (T1), 8 weeks(T2), 12 weeks (T3) from baseline levels (T0) as well as incidence of gastrointestinal and systemic adverse side events (ASE) of consumed oral iron capsules and women compliance on drug intakes in addition to direct and indirect drug costs.Results: 298 women started oral iron intake , 150 in SRFS arm and 148 in IPC arm, while at the end of study period (12 weeks), 20 (12.9%) women in SRFS versus 4 (2.6%) in IPC had severe ASE and stopped consumption of oral iron (Δ pp 10.3% at 95% C.I of 4.44, 16.68, P = 0.0004). At any follow up periods T1, T2, T3 the changes in HB were significantly higher in IPC group (P = 0.0001, P = 0.0064, P = 0.012) and changes in SF between T3 and T0 was (58.11 ± 32.34 in SRFS vs 69.63 ± 13.61 with Δ 95% CI of -11.52 (-5.97, -17.06, P = 0.0001). Also percentage of women who consumed ≥ 75% of oral iron capsules / 4 weeks were significantly higher in IPC arm than SRFS arm P = 0.006, P =0.040, P = 0.007. Moreover, the total costs of direct and indirect used drugs were significantly less in IPC arm than SRFS group at T1, T2, T3(P < 0.0001, P < 0.0001, P < 0.0001). No severe sequels were noted in pregnancy outcomes could be attributed to used medicinal oral iron. Conclusion: Oral non - ionic ferric (Fe+3) iron polymaltose complex was more effective, more tolerable as well as women were more complaint on its consumption and its total costs were lower than sustained released ferrous sulfate dried capsules in treating mild and moderate gestational iron deficiency in second and early third trimesters.