Parenteral Iron Dose Research Articles

Anemia in Chronic Kidney Disease: The State of the Art

The aging of the population has led to an increased prevalence of chronic diseases such as chronic kidney disease. Anemia is one of the most frequent complications of chronic kidney disease, with an impact not only on the quality of life but also on the patient's prognosis and associated costs. Knowledge in this therapeutic area has increased significantly: from the appearance of recombinant erythropoietin in 1989, through the use of increasing doses of parenteral iron and, more recently, to new molecules such as hypoxia-inducible factor inhibitors. The aim of this article is to present a pragmatic review of the state of the art in the epidemiology, pathophysiology, diagnosis and treatment of anemia associated with chronic kidney disease.

Role of nephrology pharmacists in the management of anemia in outpatient dialysis units: A Canadian model .

Hemodialysis patients frequently suffer from anemia. Proper utilization of therapies such as iron and erythropoiesis-stimulating agents (ESAs) is crucial to attain symptom management and established hemoglobin targets. The purpose of this study was to evaluate the clinical and financial impact of nephrology-trained pharmacists on anemia management in these patients. A retrospective study of outpatient hemodialysis patients observed between January 2010 and December 2011. In December 2010, pharmacists were tasked to manage anemia under a medical directive. Primary endpoints were compared across years using a mixed-effects model strategy. An unstructured random effects correlation matrix was utilized to capture patient-level variation in 2010 and 2011, separately. Of 202 patients identified, 163 contributed in both years, 57% were males, aged 65.18 ± 16.3 years. Hemoglobin levels were 10.95 ± 0.95 and 10.83 ± 0.94 g/dL in 2010 vs. 2011, respectively (p = 0.158), while the transfusion rate was 1.3% and 1.8%, respectively (p = 0.196). Ferritin levels of 273.5 ± 22 and 317.1 ± 12 ng/mL (p = 0.0019), iron saturation 0.30 ± 0.11 and 0.30 ± 0.05 (p = 0.838), and parenteral iron dose of 215.4 ± 100.2 and 317.1 ± 123.7 mg, respectively (p = 0.996), were identified. Finally, the average weekly ESA dose in 2010 was higher and trending up as compared to 2011 where it significantly trended down. The amount of intravenous erythropoietin alfa was 12,315.6 ± 76 vs. 11,364.1 ± 52 units/week, respectively (p = 0.0556) with expenditure of 2.8 million Canadian dollars in 2010 vs. 2.3 million Canadian dollars in 2011. The participation of a nephrology pharmacist resulted in favorable outcomes in dose optimization, decreased expenditure, and positive trends in therapeutic goal achievement.

Impact of Parenteral Iron Therapy on Hemoglobin Normalization: A Retrospective Analysis

Introduction Parenteral iron therapy is often necessary for patients with iron deficiency anemia who cannot tolerate or are nonresponsive to oral iron. Parenteral iron therapy is also used in patients with chronic diseases when oral iron is poorly absorbed or when rapid iron repletion is desirable. Several parenteral iron therapies are currently available in the US. They vary in the amount of iron dose per administration and the number of infusions required to achieve complete iron repletion. The objective of this analysis was to evaluate complete repletion of iron deficit and its effect on the likelihood of serum hemogloblin (Hgb) normalization among patients receiving various parenteral iron therapies in real world clinical practice. Methods Data was obtained from the Decision Resources Group (DRG) Real World Evidence US Data Repository. Patients (≥18 years) who were treated with parenteral iron therapy from 3/1/2015-2/28/2017 were included. Patients were required to have their most recent baseline Hgb level recorded <30 days prior to or on the date of their index (first) parenteral iron therapy claim and below the normal Hgb level (<12 g/dL for females and <13.5 g/dL for males). Patients were excluded if they received parenteral iron therapy 6 weeks prior to the date of their index iron injection (index date); received dialysis or had insufficient data to identify comorbidities 1 year prior to index date. Iron deficit was calculated using the modified Ganzoni equation. The proportion of patients receiving parenteral iron dose required for complete repletion during the 3 weeks after index date, and the proportion of patients achieving normalized Hgb levels within 1 year after index date were summarized for patients receiving ferric carboxymaltose (FCM), ferumoxytol (FM) and other parenteral iron products (OTH). Multivariable logistic regression was used to assess the likelihood of complete iron repletion within 3 weeks of index date while controlling for gender, age, comorbidities, prescription oral iron use and iron deficit level. The likelihood of Hgb normalization within 1 year of index date was assessed using multivariable logistic regression while controlling for gender, age, comorbidities, prescription oral iron use, baseline Hgb and if the patient received the complete iron repletion dose within 3 weeks of index date. Results A total of 2,966 patients were included (female [68.2%], ≥65 years [58.4%]; CKD [60.1%], congestive heart failure [50.1%], IBD [64.4%], and cancer [59.5%]). Most (95%) patients did not receive prescription oral iron therapy within 3 months before or after index date. Iron sucrose was the most commonly used parenteral therapy (46.2%), followed by FCM (23.1%), FM (13.7%), iron dextran (13.6%), and sodium ferric gluconate complex in sucrose (3.4%). Mean (SD) iron deficit in mg was 966 (303) for FCM, 1007 (317) for FM and 1011 (313) for OTH patients. FCM had the highest proportion of patients received the full iron repletion dose within the 3 weeks after index date (73.1%), followed by FM (41.4%) and OTH (18.0%). Mean (SD) total iron dose in mg received by FCM, FM and OTH patients within 3 weeks of index date was 1277.1 (446.9), 842.5 (357.6), and 534.2 (584.8), respectively. The proportion of patients who had normalized Hgb within 1 year of index date was 66.6%, 40% and 51.9% for FCM, FM and OTH, respectively. Patients treated with FCM were significantly more likely to have received their full repletion dose within 3 weeks of index date than patients treated with FM [adjusted odds ratio (AOR)] (95% CI) = 5.10 (3.66, 7.11)] or OTH [AOR (95% CI) = 17.46 (13.59, 22.42)] after adjusting for differences in iron deficit level and other covariates. Patients treated with FM also had higher likelihood of receiving full repletion dose within 3 weeks compared to OTH [AOR (95% CI) = 3.71 (2.82, 4.88)]. After adjusting for full repletion dose and other covariates, patients treated with FCM were significantly more likely to have normalized Hgb within 1 year of index date than patients treated with FM [AOR (95% CI) = 1.88 (1.38, 2.56) or OTH [AOR (95% CI) = 1.40 (1.11, 1.77). However, patients treated with FM had lower likelihood to have normalized Hgb within 1 year of index date than patients treated with OTH [AOR (95% CI) = 0.69 (0.53, 0.89)]. Conclusion The results of this analysis suggest that the choice of iron replacement product may affect the likelihood of Hgb normalization for some patients in real world practice. Disclosures Kwong: Daiichi Sankyo, Inc.: Employment. Boccia:Bristol Myers Squibb: Consultancy, Speakers Bureau; SecuraBio: Consultancy; Rigel: Speakers Bureau; Daiichi Sankyo, Inc.: Consultancy, Speakers Bureau; Amgen: Consultancy, Speakers Bureau; Celgene: Speakers Bureau; AMAG: Consultancy.

Importance of Initial Complete Parenteral Iron Repletion on Hemoglobin Level Normalization and Health Care Resource Utilization: A Retrospective Analysis.

Iron deficiency anemia is the most common form of anemia, and parenteral iron therapy is necessary in select patients. The objective of this analysis was to assess the impact of initial complete parenteral iron repletion on serum hemoglobin (Hgb) level normalization and on health care resource utilization in real-world practice. Retrospective observational study. Decision Resources Group Real-World Data Repository (United States databases). A total of 2966 patients who had a baseline Hgb level below normal (<12g/dl for females and <13.5g/dl for males) and were treated with parenteral iron between March 2015 and February 2017. The effect of receiving the required parenteral iron dose to replete the deficit, calculated by a modified Ganzoni formula, within 3weeks of the first parenteral iron therapy claim (index date) on the likelihood of Hgb level normalization, was estimated by using logistic regression. All analyses were adjusted for sex, age, comorbidities, and use of prescription oral iron therapy. The adjusted mean numbers of all-cause inpatient admissions, outpatient visits, and emergency department (ED) visits within 6months and 1year after the index date were compared between patients with and without normalized Hgb levels by using negative binomial regression. Of the 2966 included patients, 33.9% received the required iron dose within 3weeks of the index date, and 19.6%, 48.2%, and 53.9% had a normalized Hgb level within 8weeks of the index date, within 1year of the index date, and until the end of data availability, respectively. Patients who received the required iron dose within 3weeks of the index date were significantly more likely to have a normalized Hgb level within 8weeks of the index date and at any time during the study period than those who did not: adjusted odds ratio (OR) (95% confidence interval [CI]) 2.67 (2.20, 3.24) and 2.33 (1.96, 2.77), respectively. Hgb level normalization within 1year of the index date was associated with fewer inpatient admissions and outpatient visits and a similar number of ED visits compared with no Hgb level normalization 1 year after the index date. The results of these analyses underscore the importance of initial complete parenteral iron repletion for rapidly improving clinical outcomes. Prompt achievement of a normalized Hgb level may also provide an opportunity to reduce health care resource utilization in patients with iron deficiency anemia receiving parenteral iron therapy.

PB2045 EFFICACY &amp; SAFETY OF INTRAVENOUS FERRIC CARBOXYMALTOSE IN IRON DEFICIENCY ANEMIA: A PROSPECTIVE STUDY

Background:Iron deficiency anemia (IDA) is the most common nutritional anemia globally. Goal of iron replacement therapy are correction of anemia and repletion of body iron stores. Oral iron replacement is the preferred route in general. However, response to oral iron replacement therapy is often suboptimal due to poor compliance to treatment resulting from gastrointestinal intolerance and prolonged duration of oral iron therapy. Ferric carboxymaltose is a relatively recently approved parenteral iron formulation which can be administered in large doses of upto 1000 mg in a single infusion.Aims:The present study describes the efficacy &amp; safety of intravenous ferric carboxymaltose for treatment of iron deficiency anemia in a tertiary institution in India.Methods:This non‐randomised prospective study included 77 patients of age ≥ 12 years with confirmed diagnosis of iron deficiency anemia between January 2018 &amp; January 2019. Detailed history was taken &amp; examination performed for signs &amp; etiology of IDA. The cut‐off serum ferritin level for IDA diagnosis was &lt; 15 ng/ml. Pregnant females and patients with concurrent vitamin B12 deficiency were excluded. All patients were treated with Injection Ferric Carboxymaltose (FCM) by I.V. infusion over 30 minutes in day care. Total dose of parenteral iron was calculated according to Ganzoni Formula: Total iron deficit (mg) = 2.4 x body weight (kg) x [target haemoglobin – actual haemoglobin (g/dl)] + 500 mg (depot iron). The maximum dose of FCM administered in a single infusion was 1000 mg. Patients with total iron dose &gt; 1000 mg received two divided doses one week apart. Patients also received oral folic acid at 5 mg/day dose for at least 3 weeks. Appropriate workup for etiology of IDA was performed in all patients. Therapeutic response was assessed after 3 weeks of first FCM dose &amp; was defined as hemoglobin increase of ≥ 2 g/dl from baseline.Results:The median age of patients was 33 years (range 16 ‐ 75 years) and majority (78%) were females. The median baseline hemoglobin was 5 g/dl (range 2.0 ‐ 8.6 g/dl). Therapeutic response was achieved in 100% patients. Mean increase in haemoglobin at 3 weeks was 4.2 g/dl (range 2.8 ‐ 5.5 g/dl). One patient had mild headache during FCM infusion. There was no infusion‐related toxicity or any other adverse event.Summary/Conclusion:In our study, intravenous ferric carboxymaltose was found to be highly effective &amp; safe alternative to oral iron for treatment of iron deficiency anemia, with excellent patient compliance. It is ideally suited for patients who require rapid replenishment of iron stores.

Functional iron deficiency in patients on hemodialysis: prevalence, nutritional assessment, and biomarkers of oxidative stress and inflammation

Introduction:Anemic patients with chronic kidney disease (CKD) can be divided into anemic patients without or with functional iron deficiency (FID). The increase in the number of cases of hemosiderosis in patients on hemodialysis (HD) attributed to excessive intravenous iron replacement has called for the investigation of the factors involved in the genesis of FID.Objectives:This study aimed to describe the prevalence of FID in patients with CKD on HD, characterize the included individuals in terms of clinical and workup parameters, and assess their nutritional, oxidative stress, and inflammation statuses. This cross-sectional study assembled a convenience sample of 183 patients with CKD on HD treated in Southern Brazil. Patients meeting the inclusion and exclusion criteria were divided into two groups, one with anemic subjects with FID and one with anemic patients without FID. Participants answered a questionnaire probing into socio-epidemiological factors, underwent anthropometric measurements, and were tested for markers of anemia, oxidative stress, inflammation, and nutrition.Statistical analysis:The date sets were treated on software package GraphPad InStat version 3.1. Variables were tested with the Kolmogorov-Smirnov, chi-square, Student’s t, and Mann-Whitney tests. Statistical significance was attributed to differences with a p < 0.05.Results:Markers of inflammation were not statistically different between the two groups. Markers of anemia and nutrition were significantly lower in patients with FID. Patients with FID were prescribed higher doses of parenteral iron (p < 0,05).Discussion:FID was associated with lower nutritional marker levels, but not to increased levels of markers of inflammation or oxidative stress, as reported in the literature. Additional studies on the subject are needed.

Use of Encapsulation Technology to Improve the Efficiency of an Iron Oral Supplement to Prevent Anemia in Suckling Pigs.

Simple SummaryIn animal nutrition, encapsulation technologies have been poorly explored, even though they may improve oral iron supplementation in suckling pigs. We hypothesized that the encapsulation of an oral supplement could enhance iron bioavailability for suckling pigs. We compared the levels of biomarkers for iron nutritional status among three groups of animals: piglets receiving oral encapsulated supplements, individuals receiving oral non-encapsulated supplements (as control group), and animals who were supplemented by parenteral route (strategy currently used in pig production systems). All treatments prevented anemia at weaning; however, only oral treatments prevented the first stage of anemia, which is iron depletion. In conclusion, piglets supplemented with encapsulated iron showed a higher concentration of serum ferritin and, therefore, had better iron reserves.The objective of this study was to develop an encapsulated iron supplement for oral ingestion and to determine its effect on the iron nutrition status of suckling pigs. Encapsulated and non-encapsulated iron supplement was prepared. Seventy-two neonatal piglets were assigned to three experimental groups: (1) parenteral group (gold standard treatment), which received one dose of parenteral iron (200 mg), 2 days of age, (2) “non-encapsulated” group (as a control group), which received 4 oral doses of unencapsulated iron supplement at 2, 7, 12 and 17 days of age, and (3) “encapsulated” group, which received 4 oral doses of encapsulated iron supplement on the same days. The encapsulated and unencapsulated iron supplements contained 65.2 and 65.0 mg/iron/dose, respectively. Parenteral treatment was not sufficient to ensure an adequate iron nutritional state in piglets at the end of the lactation period, showing iron depletion (serum ferritin: 8.4 µg/L). In contrast, oral supplementation prevented the development of iron depletion. Higher serum ferritin values were observed in the encapsulated (19.9 µg/L) compared to the unencapsulated group (17.4 µg/L) (p = 0.020). In conclusion, the use of four oral doses of an encapsulated iron supplement prevents iron deficiency anemia and its previous stages in suckling pigs.

Importance of Complete Parenteral Iron Replacement on Hemoglobin Normalization: A Retrospective Analysis

IntroductionIron deficiency anemia (IDA) is the most common cause of anemia in the United States (US) and occurs most often in patients with chronic diseases and inflammation.Although oral iron therapy is often prescribed for iron deficiency anemia, parenteral iron therapy is necessary for patients who cannot tolerate or are nonresponsive to oral iron. Parenteral iron therapy is also used in patients with chronic diseases such as inflammatory bowel disease, cancer or chronic kidney disease when rapid iron replacement is desirable. Currently, several parenteral iron therapies are available in the US and they vary in dose strengths and administration schedules. There are limited data on the dosing patterns of parenteral iron therapy and its effectiveness in the real world setting. The objective of this analysis was to assess the importance of parenteral iron dosing on serum hemoglobin (Hgb) level normalization in real world clinical practice.MethodsData was obtained from the Decision Resources Group (DRG) Real World Evidence Data Repository US database, which includes medical and pharmacy claims, and electronic health record data representing more than 300 million patient lives. Adult patients (≥18 years of age) who were treated with parenteral iron between 3/1/2015 and 2/28/2017 were included in the analysis. Eligible patients were required to have their most recent baseline Hgb level below normal (Hgb <12 g/dL for females and <13.5 g/dL for males) and recorded <30 days prior to or on the date of their index (first) parenteral iron therapy claim. Patients were excluded from the study if they received parenteral iron 6 weeks prior to the index date, received dialysis, or had insufficient data to identify comorbidities one year prior to index date.Parenteral iron dose required to correct for iron deficit was calculated using the Ganzoni formula. Patients were categorized based on whether or not they received the full amount of parenteral iron required to correct for iron deficit during the 3 weeks after the index date. Patients were assessed to determine the proportions of patients achieving normalized Hgb levels (≥12 g/dL for females and 13.5 g/dL for males) within 8 weeks after index date and until the end of data availability. Logistic regression was used to estimate the effect of receiving the full amount of required parenteral iron dose within 3 weeks of treatment initiation on the likelihood of Hgb level normalization while controlling for gender, age, comorbid conditions, and use of prescription oral iron therapy.ResultsA total of 2,966 patients were included in the analysis (68.2% female, 58.4% ≥65 years; 60.1% chronic kidney disease, 50.1% congestive heart failure, 64.4% inflammatory bowel disease, and 59.5% cancer). Most (95%) patients did not receive prescription oral iron therapy within 3 months before or after index date. Mean (SD) number of injections during the 3-week period after index date was 2.5 (1.4).Parenteral iron dose required to correct for iron deficit ranged from 343.7mg to 1915.0mg. Parenteral iron dose received during the first three weeks ranged from 600mg to 2000mg. About a third of patients (33.9%, n=1,006) received the full amount of required parenteral iron dose within the 3-week treatment course. A total of 582 (19.6%) patients had normalized Hgb levels within 8 weeks of treatment initiation and 53.9% (n=1,599) had normalized Hgb levels at any time during the entire study period (median study follow-up=108 weeks).Patients who received the full amount of required dose to correct for iron deficit within 3 weeks of treatment initiation were significantly more likely to have normalized Hgb levels within 8 weeks of treatment initiation than those patients who did not receive the full amount of required dose over the same time period [adjusted odds ratio (95% CI) =2.67 (2.20, 3.24)]. Similarly, when normalized Hgb levels were analyzed using data available for the entire study period, patients who received the full amount of required dose within 3 weeks of treatment initiation were significantly more likely to have normalized Hgb levels than those patients who did not receive the full amount of required dose within 3 weeks of treatment initiation [adjusted odds ratio (95% CI) =2.32 (1.96, 2.75)].ConclusionThe results of this analysis underscore the importance of initial complete iron replacement on rapidly improving clinical outcomes for IDA patients receiving parenteral iron therapy. DisclosuresLaVallee:Daiichi Sankyo, Inc.: Research Funding. Cronin:Daiichi Sankyo, Inc.: Research Funding. Bansal:Daiichi Sankyo, Inc.: Research Funding. Kwong:Daiichi Sankyo, Inc.: Employment.

Characterization of hepatic and cardiac iron deposition during standard treatment of anaemia in haemodialysis.

Parenteral iron is integral in the treatment of anaemia of chronic kidney disease patients on haemodialysis (HD). However, increased liver iron concentration (LIC) can result from such treatment, and this correlates poorly with serum ferritin or transferrin saturation values. It is unclear whether increased cardiac iron concentration also occurs in this setting. We aimed to evaluate the relationship of intravenous iron supplementation to hepatic and cardiac iron deposition in chronic HD subjects. A cohort of 10 patients on chronic HD for at least 1 year underwent MRI-based quantitation of hepatic and cardiac iron content to evaluate the relationship between intravenous iron supplements and hepatic and cardiac iron deposition. The results were compared against the cumulative parenteral iron dose and serum iron markers. The median age was 61 years (95% confidence interval (CI) 50-71), HD time 2.5 years (95%CI 2.0-5.3) and cumulative iron dose 4300 mg (95%CI 2110-9045). Hepatic iron concentration was elevated in eight of 10 subjects (median 46 mmol/kg, range 31-76). Cardiac iron levels were within the reference range in all subjects. There was poor correlation between conventional haematinic values and either LIC or cardiac iron levels. None of the study subjects exhibited elevated cardiac iron concentration. Whilst HD patients receiving standard parenteral iron therapy have elevated LICs, this is not associated with cardiac iron deposition. Transferrin saturation and serum ferritin levels are poor markers of either liver or cardiac iron deposition in HD subjects.

The effects of cinacalcet treatment on bone mineral metabolism, anemia parameters, left ventricular mass index and parathyroid gland volume in hemodialysis patients with severe secondary hyperparathyroidism.

The aim of this study was to investigate the effects of cinacalcet therapy on anemia parameters, bone mineral metabolism, left ventricular mass index (LVMI) and parathyroid gland volume in hemodialysis (HD) patients with secondary hyperparathyroidism. Twenty-five HD patients (M/F: 11/14, mean age: 45.2±17.9 years, mean HD duration: 96.4±32.7 months) were included in this prospective pilot study. The indication to start calcimimetic therapy was persistent serum levels of parathyroid hormone (PTH)>1000 pg/mL, refractory to intravenous (i.v.) vitamin D and phosphate-binding therapy. The initial and one-year results of adjusted serum calcium (Ca+2), phosphate (P), Ca×P product, PTH, hemoglobin (Hb) and ferritin levels, transferrin saturation index (TSAT), median weekly erythropoietin (EPO) dose, LVMI, and parathyroid volume by parathyroid ultrasonography were determined. There were no differences between pre- and post-treatment levels of serum Ca+2 (P=0.853), P (P=0.447), Ca×P product (P=0.587), PTH (P=0.273), ferritin (P=0.153) and TSAT (P=0.104). After 1 year of calcimimetic therapy, the Hb levels were significantly higher than the initial levels (P=0.048). The weekly dose of EPO decreased with no statistical significance. The dose of cinacalcet was increased from 32.4±12.0 to 60.0±24.4 mg/day (P=0.01). There were no differences between the pre- and post-treatment results regarding weekly vitamin D dose, parenteral iron dose, LVMI and parathyroid volume. The results of our study suggest that cinacalcet therapy might have an additional benefit in the control anemia in HD patients.

PTH-034 The Safe And Effective Treatment Of Iron Deficiency With Iron Isomaltoside 1000 - Clinical Experience From A Uk Gastroenterology Unit

IntroductionParenteral iron has been used increasingly over the last decade to treat specific patient groups with iron deficiency (ID) anaemia. There is, however, limited evidence of safety and efficacy in...

Avaliação da eficácia do uso intravenoso de sacarato de hidróxido de ferro III no tratamento de pacientes adultos com anemia ferropriva

The objective of this study was to evaluate the efficacy of intravenous iron III-hydroxide saccharate to treat adult patients with iron deficiency anemia. Between January 2003 and December 2005 we studied 50 patients with iron deficiency anemia who presented intolerance or inadequate response to oral iron therapy, or hemoglobin level < 7 g/dL. The main laboratory tests performed were: complete blood cell count, reticulocyte count, serum iron, total iron-binding capacity and serum ferritin. The patients received a weekly dose of 200 mg of iron diluted in 250 mL of 0.9% sodium chloride solution administered intravenously during 30 minutes. It was performed until a hemoglobin level = 12.0 g/dL for women or13.0 g/dL for men was reached or completing the administration of the total dose of parenteral iron recommended for each patient. The median age of the patients studied was 45 years (age range from 18 to 76). Forty out of 25 patients (80%) were women. The most common cause of iron deficiency anemia was abnormal uterine bleeding observed in 62.5% of female patients (25 out of 40) and partial gastrectomy in 70% of male patients (7 out of 10). Twenty-four (48%) patients were included in this study due to a lack of response to oral iron therapy, 22 (44%) showed intolerance to oral iron and 2 (8%) presented with a hemoglobin level < 7.0 g/dL. The mean hemoglobin and ferritin values were 8.48 g/dL and 4.65 ng/mL (pretreatment) and 12.34 g/dL and 93.20 ng/mL (post-treatment) (p<0.001), respectively. The average increase of hemoglobin was 3.61 g/dL and 4.83 gdL for women and men, respectively. Correction of anemia was obtained in 26 out of 40 female patients (65%) and in 9 out of 10 male patients (90%). Six patients received blood transfusions before starting intravenous iron treatment. None of the 50 studied patients needed red blood cell transfusions during or after completing the treatment. The use of intravenous iron III-hydroxide saccharate is an efficacious and safe option in the treatment of adult patients with iron deficiency anemia who lack satisfactory response to oral iron therapy. This treatment option should be considered mainly in patients with severe anemia in order to obtain rapid increases in the hemoglobin levels and to avoid blood transfusions.

O uso intravenoso de sacarato de hidróxido de ferro III em pacientes com anemia ferropriva

To evaluate the efficacy of intravenous iron III-hydroxide saccharate for treating adult patients with iron deficiency anemia lacking satisfactory response to oral iron therapy. Between January 2003 and January 2004, 25 patients with iron deficiency anemia who presented intolerance or inadequate response to iron oral therapy, or hemoglobin level < 7 g/dl were studied. The main laboratory tests performed were: complete blood cell count, reticulocyte count, serum iron, total iron-binding capacity, serum ferritin. Patients received a weekly dose of 200 mg of iron diluted in 250 mL of 0.9% sodium chloride solution administered intravenously for 30 minutes. Treatment continued until a hemoglobin level = 12 g/dL for women and = 13 g/dL for men were obtained or until full administration of the total dose of parenteral iron recommended for each patient. Median age of the patients studied was 45 years (ages ranging from 31 to 70). Nineteen out of 25 patients (76%) were women. The most common cause of iron deficiency anemia was abnormal uterine bleeding observed in 68% of the female patients (13 out of 19) and partial gastrectomy observed in 67% of the male patients (4 out of 6). Seventeen (68%) patients were included in this study because they did not respond to oral iron therapy, 24% (6 out of 25) showed intolerance to oral iron and 8% (2 out of 25) presented hemoglobin level < 7 g/dl. Correction of anemia was obtained in 12 out of 19 female patients (63%) and in 5 out of 6 male patients (83%). The mean hemoglobin and ferritin values were 8.09 g/dl and 4.20 ng/ml (pre-treatment) and 12.42 g/dl and 87.78 ng/ml (post-treatment) (p < 0.001), respectively. The average increase of hemoglobin was 3.74 g/dl, ranging from 1.30 to 7.60 g/dl. None of the patients received blood transfusion during or after the intravenous iron treatment. The use of intravenous iron III-hydroxide saccharate is an efficacious and safe option in the treatment of adult patients with iron deficiency anemia lacking satisfactory response to oral iron therapy. This option of treatment should be considered mainly for patients with severe anemia in order to obtain rapid increase of the hemoglobin level and avoid blood transfusion.

Iron supplementation in adolescent hemodialysis patients

Iron supplementation is necessary in children on hemodialysis, but the optimal protocol remains unknown. We studied the effects of changing our unit's protocol from oral iron with periodic doses of parenteral iron dextran to routine administration of parenteral sodium ferric gluconate on anemia and iron parameters. We followed seven hemodialysis patients aged 15 20 years (mean 17 years). Hemoglobin, hematocrit, serum iron, transferrin saturation, ferritin, erythropoietin dose, total elemental iron dose and total iron cost for the six months prior to the protocol change were compared to the same variables during the six months following the change. There was no statistically significant difference between the doses of parenteral iron between the two protocols; however, the total dose of elemental iron administered in the oral iron plus iron dextran protocol was greater than in the sodium ferric gluconate protocol (19.6+/-13.1 (mean+/-SD) mg/kg/week versus 1.1+/-0.3 mg/kg/week; p = 0.03). Both protocols had equivalent efficacy with respect to hemoglobin, ferritin and other measures of iron stores. On the other hand, the costs of sodium ferric gluconate were significantly higher than those of oral iron plus intermittent iron dextran (157.75+/-45.94 $/patient/month versus 52.08+/-49.88 $/patient/month; p = 0.01). Routine administration of sodium ferric gluconate is equivalent if not superior to use of oral iron plus iron dextran for maintenance of iron stores in adolescents on hemodialysis, but more expensive.

Successful Treatment of Hemosiderosis with Regular Phlebotomy and Recombinant Human Erythropoietin

A 55-year-old female patient with hemosiderosis induced by administration of excessive doses of parenteral iron was successfully treated with regular phlebotomy combined with recombinant human erythropoietin (rHuEPO). Ferrokinetic data before therapy showed 28.0 mumol/l of serum iron, 4.1 mumol/l of unsaturated iron-binding capacity, 4,060 ng/ml of serum ferritin, 148 min of plasma iron disappearance time, 45% of red cell iron utilization and 0.4 mg/kg/day of plasma iron turnover rate. She had 300-ml phlebotomies, first every other week then weekly, and subcutaneous injections of rHuEPO twice a week. Two years later, the total volume of phlebotomized blood reached 31 liters and her ferrokinetic data showed: serum iron 8.6 mumol/l, iron-binding capacity 39.6 mumol/l, serum ferritin 277 ng/ml, plasma iron disappearance time 52 min, red cell iron utilization 100% and plasma iron turnover rate 0.5 mg/kg/day. During the phlebotomy therapy, her hemoglobin levels were maintained above 12 g/dl. No adverse effect due to rHuEPO occurred. These findings provide evidence for the efficacy of rHuEPO in multiple phlebotomy therapy for hemosiderosis and may open new avenues for its clinical application.

Hemosiderosis secondary to chronic parenteral iron therapy in maintenance hemodialysis patients.

Autopsy data on 24 chronic maintenance hemodialysis patients who had received varying doses of parenteral iron as the iron-dextran complex were reviewed for evidence of iron overload (hemosiderosis) and tissue fibrosis or organ dysfunction (hemochromatosis). Hemosiderosis was frequent in patients who received high total doses of iron but absent in those who received little or no iron. The degree of tissue iron did not increase with increased iron administration above a total of 2.5 g. Hemochromatosis or organ dysfunction secondary to tissue iron deposition was not noted in any patient. Chronic parenteral iron administration may improve anemia and result in tissue iron deposition but does not lead to hemochromatosis.

The Use of FE59and CR51for Estimating Red Cell Production and Destruction: An Interpretive Review

Abstract In surveying some of the limitations of studies with Cr51 and Fe59 my purpose has been not to deny their usefulness but to put them in perspective. These technics have made possible many extensions of the fundamental understanding of red cell physiology and iron metabolism. They will continue to be valuable experimental tools. It is hoped that if some of the limitations of isotope technics are considered, the non-experimental use of these isotopes will be confined to situations in which otherwise unavailable information of diagnostic or therapeutic importance can be obtained. Unfortunately isotope technics are used when more conventional means would be adequate or even preferable. An extreme example is the suggestion24 that repeated Fe59 turnover studies might be used to determine the total dose of parenteral iron (as Imferon or saccharated iron oxide) to be given in iron deficiency anemia, pointing out that in so doing the possibility of iatrogenic hemochromatosis could be avoided. The usual calculations for determining dose25 however are not only safer but more accurate. The use of Fe59 and Cr51 entails some risk, the main hazards being hepatitis, with the use of donor plasma or cells, and the possibility of untoward effects from radiation. An estimate of the risk of hepatitis can be gained from its incidence after transfusion. The radiation hazard is more difficult to assess. Leukemia has occurred after large doses of radiation but the extent of the radiation hazard is unknown from the much smaller doses of radiation employed in the usual isotopes studies. Certainly the risk is not such as to preclude the use of isotopes to obtain information essential for diagnosis. However, when such information can be obtained by other means or when results cannot be adequately interpreted, the use of isotopes in clinical medicine appears unwarranted. In considering the use of isotopes in the doubtful case, the dose of radiation to be delivered should not be thought of as an isolated event but rather as adding to a total radiation dose, which as shown by the British survey28 may be appreciable.