Oral Iron Group Research Articles

A Prospective Randomized Controlled Trial to Assess the Effect of Intravenous versus Oral Iron Therapy in the Treatment of Preoperative Anaemia

Background: Improving preoperative anaemia is associated with a better surgical outcome. There is lack of data regarding treatment of preoperative anaemia with intravenous versus oral iron. Objective: Assessment of efficacy of oral iron sulphate versus a single intravenous iron polymaltose and subsequent effect on perceived quality of life in both treatment groups. Patients and methods: We conducted a prospective randomised controlled trial with iron therapy for the treatment of Iron Deficiency Anaemia (IDA) patients who were undergoing elective joint arthroplasty. At a single institution, we recruited 44 patients who were randomized to a single intravenous iron polymaltose infusion (16/22) versus oral daily iron sulphate (17/22). Median age was 68 years (range, 45-91) with a male to female ratio of 14:19. Results: After iron therapy, the immediate mean preoperative Hb was increased to 128 g/L (SD ± 11.05) in the IV iron group versus 118 g/L (SD ± 9.23) in the oral iron group (p=0.01) compared to 116 g/L (SD ± 8.46) in the control group (p=0.001). The average length of stay in the hospital for the IV iron group was 6 days (SD ± 2.51) compared to 8 days (SD ± 3.62) in the oral iron group and 8 days (SD ± 4.18) in the control group (p=0.04). Average transfused blood units were 1.5 units in the IV iron group versus 2 units in the oral iron group (p=0.09) and 2.4 units in the control group (p = 0.04). There was a significant improvement of the symptoms of anaemia (p=0.03) after treatment in the IV versus oral iron group with further improvement at 3 months follow-up (p=0.003). Conclusion: Our data suggest that IV iron therapy is superior to oral iron in improving preoperative Hb and hence overall outcome for patients with preoperative IDA. Further trials that aim to improve and optimize preoperative and postoperative Hb are warranted.

Iron Sucrose Versus Oral Iron Therapy in Pregnancy Anemia

Background:Iron deficiency anemia (IDA) is the most common medical problem in pregnancy. Parenteral iron is a useful treatment, although iron dextran use decreased due to anaphylaxis. Iron sucrose is a newer agent that has overcome the shortcomings of iron dextran.Objective:The aim of this study was to compare the efficacy and tolerance of intravenous iron sucrose (IVIS) therapy with oral iron (OI) therapy in pregnant women with IDA and to study the factors influencing treatment.Materials and Methods:This prospective, randomized clinical trial included pregnant women between 14 and 36 weeks with established IDA who were treated with IVIS or OI (ferrous fumarate). All patients were monitored for laboratory response and adverse effects. Independent sample-t test, Chi square test and ANOVA were used for statistical analysis. P < 0.05 was considered significant.Results:Although hemoglobin increased in both the groups, increase in the reticulocyte count and percentage increase in hemoglobin was significantly higher in the IVIS group than in the OI group (23.62% vs. 14.11%). Serum ferritin was significantly higher in the IVIS group than in the OI group (P = 0.000). The IVIS group had no major side-effects. Compliance was good with OI, although 23% had gastrointestinal side-effects. Patient weight, gestation at diagnosis, initial hemoglobin and ferritin levels did not influence the response to treatment.Conclusion:IVIS is safe and effective in the treatment of IDA during pregnancy. Iron stores increased better with IVIS compared with OI.

Efficacy and safety of ferric carboxymaltose in correcting iron-deficiency anemia: a review of randomized controlled trials across different indications

Ferric carboxymaltose (FCM, Ferinject) was effective and well tolerated in the treatment of iron-deficiency anemia (IDA) in nine, Phase III, randomized, controlled, multicenter trials in a diverse range of indications, including patients with inflammatory bowel disease (IBD), post-partum anemia (PPA) or abnormal uterine bleeding (AUB), chronic heart failure (CHF), non-dialysis-dependent chronic kidney disease (CKD) and those undergoing hemodialysis (HD). In most trials, patients received either FCM doses of < or = 1000 mg, administered intravenously (i.v.) over < or = 15 min. or oral ferrous sulfate (FeSulf) 325 mg (65 mg iron), three times daily (t.i.d.), or 304 mg (100 mg iron), twice daily (b.i.d.). In one trial, patients on HD received 200 mg i.v. of either FCM or iron sucrose (ISC), two-to-three times weekly. In a pilot study in patients with CHF and CKD, patients received 200 mg of FCM by push injection compared with 200 mg of ISC slow injection. FCM was usually administered until the patient's calculated total iron replacement dose was achieved. Treatment with FCM improved indices of anemia (hemoglobin [Hb], ferritin and transferrin saturation [TSAT] values). In patients on HD with IDA secondary to CKD, FCM demonstrated comparable efficacy to ISC in achieving an increase in Hb. In patients with IBD or PPA, improvements in Hb levels were more rapid with FCM than with FeSulf. Patients with PPA receiving FCM compared with those receiving oral iron achieved an Hb rise > or = 2.0 g/dl earlier (7 days compared with 14 days; p < 0.001), were more likely to achieve an Hb rise > or = 3.0 g/dl at any time beginning at day 14 (86.3% compared with 60.4%; p < 0.001), and achieve an Hb > 12.0 g/dl at the end of the study (Day 42; 90.5% compared with 68.6%, p < 0.01). Serum ferritin increased in the i.v. FCM treatment group, but not in the oral iron group. Differences between groups were significant at each study interval. TSAT increased significantly at every interval in both groups; however, FCM-treated patients showed higher TSAT at each interval after the first week. FCM improved patient quality of life to an equivalent extent to oral FeSulf in patients with IBD or PPA, and to a greater extent than oral FeSulf in women with AUB. FCM also improved quality of life as well as functional symptoms and exercise capacity in patients with CHF. Safety data from more than 3000 patients showed that FCM was well tolerated. No safety concerns have been identified in breastfed infants of mothers receiving FCM. FCM is, therefore, an effective and well-tolerated option in the treatment of IDA.

Efficacy of IV Iron Compared to Oral Iron for Increment of Haemoglobin Level in Anemic Chronic Kidney Disease Patients

Introduction: Anemia is the most common finding in chronic kidney disease patients. Iron supplements are commonly prescribed for these patients with or without erythropoietin therapy by means of oral and intravenous iron. Both oral and intravenous irons have their own advantage and disadvantage, and the efficacy is also different. The objective of the study is to analyze the efficacy of oral and intravenous iron in chronic kidney disease patients on erythropoietin therapy, an erythropoiesis stimulating agents for increment of haemoglobin.&#x0D; Methods: This is a prospective study comparing intravenous iron to oral iron in chronic kidney disease patients who underwent maintenance hemodialysis at different centers and visited Kathmandu Medical College Teaching Hospital from April 2010 to April 2011. Patients having a haemoglobin level of &lt; 11 g/dl, transferrin saturation (TSAT) &lt; 25%, ferritin &lt; 300ng/ml and who were on erythropoietin therapy were allocated alternately into two groups to receive oral iron (iron fumarate) or IV iron (iv sucrose). Haemoglobin was measured after 30 days of therapy.&#x0D; Results: A significant increase in haemoglobin levels was observed in both groups. But the mean haemoglobin increment was more in the IV iron group than in the oral iron group. Sixty percent 60% of patients in the IV iron group had an increase in the haemoglobin level of more than 1gm/dl while only 20% of the oral iron group had this increase.&#x0D; Conclusions: Intravenous iron therapy is more effective in raising the hemoglobin level in hemodialysis dependent chronic kidney disease patients.&#x0D; Keywords: anemia; chronic kidney disease; iron.

Ensayo clínico aleatorizado para evaluar la efectividad de dos vías de administración de hierro, oral e intravenosa, en el tratamiento de la anemia ferropénica posparto

ObjectiveTo compare the effect of treatment with oral and intravenous iron in postpartum iron deficiency anemia. Material and methodThirteen women with hemoglobin values of 7-10g/dl and ferritin values of < 15 microgram/l at 24h postdelivery were randomized in two groups: one group received intravenous iron (two doses of 200mg ferrous sucrose) on days 2 and 4 after labor and the other group received standard treatment with oral ferrous sulphate 200mg twice daily for 6 weeks. ResultsBy day 7, ferritin levels were significantly higher (p=0.002) in the group treated with intravenous iron (298.3±159,1μg/l) than in that treated with oral iron (21.3±9.4μg/l). By day 14, differences between these two groups were also detected (123.7±65.1μg/l in the intravenous iron group and 24.6±9.3μg/l in the oral iron group, p=0.004). Hemoglobin and hematocrit levels increased in both groups on days 7, 14 and 42 with no statistically significant differences. Adverse effects were detected in the oral iron group only (29%, n=2), although all were mild. ConclusionsIntravenous iron could be an alternative in the treatment of postpartum iron deficiency anemia, especially in patients who are unable to tolerate or who reject oral formulations.

The effects of oral iron supplementation on the progression of anemia and renal dysfunction in patients with chronic kidney disease

Oral iron traditionally has been administered to patients with chronic kidney disease (CKD). However, there are limited data on the effect of oral iron in CKD patients. Here, we evaluate the effects of oral iron therapy on renal anemia and progression of renal disease in CKD patients. Anemic patients with nondialytic CKD who were naive to erythropoiesis-stimulating agents (ESAs) were recruited for the prospective observational study. The participants were classified into oral iron or control group, and they were asked to keep their treatment status for 1 year. The primary outcomes were change in Hb and estimated glomerular filtration rate (eGFR). A total of 182 participants were enrolled and 138 completed a 12-month follow-up. No change in Hb level was observed during the follow-up period in the iron group, whereas a significant decrease in Hb was observed in the control group. Oral iron supplementation was effective, especially in patients with eGFR < 30 ml/min/1.73 m2. The changes in eGFR did not differ between the two groups. The incidences of drug-related adverse events were equivalent in two groups. Oral iron supplementation might attenuate the progression of anemia in nondialytic CKD patients without ESAs and not impact kidney function.

Optimal Iron Replacement for Colorectal Cancer-Induced Anaemia

Introduction: Iron deficiency anaemia (IDA) is commonly a result of colorectal cancer. Higher preoperative haemoglobin (Hb) is associated with an improved post-operative survival. The endpoint of normalising patients Hb is to reduce the need for perioperative blood transfusion which has oncological, safety and economic benefits. Methods: This study aims to compare the overall effect and cost between oral iron and two forms of parenteral iron, in raising the Hb of 53 consecutive colorectal cancer patients with IDA. The pre- and post-treatment Hb were measuring over time for oral and two formulations of parenteral iron (CosmoFer® and Venofer®), as were the need for supplemental pre-operative blood transfusions. The Total Hb rise and Hb rise/day were calculated as was the overall cost (including blood transfusions) in each of the three iron supplementation groups. Results: Both total Hb rise and Hb rise/day were significantly higher in the Venofer® (p=0.048, p=0.002) and CosmoFer® groups (p=0.034 & p=0.001) over oral iron. The oral iron group required significantly more blood than the Venofer® (p=0.04) and CosmoFer® groups (p=0.01). Although there was a trend for oral iron to cost more than parenteral, this did not reach significance. Conclusions: This study suggests that the end point of transfusion reduction is possible by the increased Hb rise rate of Venofer® or CosmoFer®. In addition, parenteral iron supplementation is no more costly than the traditional oral route, taking into account blood transfusion requirement.

High incidence of iron depletion and restless leg syndrome (RLS) in regular blood donors: intravenous iron sucrose substitution more effective than oral iron

Iron depletion is common in regular blood donors. The objective of the study was to investigate the frequency and severity of iron depletion in regular blood donors and whether IV iron is more effective than oral to avoid iron depletion and symptoms thereof, especially restless legs syndrome (RLS). One hundred and twenty blood donors with at least five previous whole blood donations were randomized to receive either IV iron sucrose (Venofer(®), RenaPharma/Vifor, Uppsala, Sweden), 200 mg, or to 20×100 mg of oral iron sulphate (Duroferon(®), GlaxoSmithKline, Stockholm, Sweden), after each blood donation during 1 year. Iron status and RLS incidence and severity were investigated. Iron status was generally poor among regular blood donors, especially in women, with a high incidence of iron depletion (>20%) and RLS (18%). The IV iron group increased storage iron to a greater extent than the oral iron group after 12 months (P=0·0043). Female donors were more responsive to IV iron sucrose compared to oral iron sulphate, particularly female donors below 50 years of age. RLS severity scores were significantly lower in the IV iron group. The two treatments were safe. Iron status is poor in regular blood donors, restless legs syndrome is common, and the routine iron supplementation is insufficient. IV iron sucrose substitutes iron loss in blood donors more efficiently compared with oral iron sulphate, especially in women. Iron substitution to blood donors should be individualized and based on P-ferritin monitoring.

Intravenous versus oral iron supplementation for correction of post-transplant anaemia in renal transplant patients

BackgroundPost-transplant anaemia remains a common problem after kidney transplantation, with an incidence ranging from nearly 80% at day 0 to about 25% at 1 year. It has been associated with poor graft outcome, and recently has also been shown to be associated with increased mortality.Our transplant unit routinely administers oral iron supplements to renal transplant recipients but this is frequently accompanied by side effects, mainly gastrointestinal intolerance. Intravenous iron is frequently administered to dialysis patients and we sought to investigate this mode of administration in transplant recipients after noticing less anaemia in several patients who had received intravenous iron just prior to being called in for transplantation.MethodsThis study is a single-centre, prospective, open-label, randomised, controlled trial of oral versus intravenous iron supplements in renal transplant recipients and aims to recruit approximately 100 patients over a 12-month period. Patients will be randomised to receive a single dose of 500 mg iron polymaltose (intravenous iron group) or 2 ferrous sulphate slow-release tablets daily (oral iron group). The primary outcome is time to normalisation of haemoglobin post-transplant. Prospective power calculations have indicated that a minimum of 48 patients in each group would have to be followed up for 3 months in order to have a 90% probability of detecting a halving of the time to correction of haemoglobin levels to ≥110 g/l in iron-treated patients, assuming an α of 0.05. All eligible adult patients undergoing renal transplantation at the Princess Alexandra Hospital will be offered participation in the trial. Exclusion criteria will include iron overload (transferrin saturation >50% or ferritin >800 μg/l), or previous intolerance of either oral or intravenous iron supplements.DiscussionIf the trial shows a reduction in the time to correction of anaemia with intravenous iron or less side effects than oral iron, then intravenous iron may become the standard of treatment in this patient group.

Iron prophylaxis in pregnancy: Intravenous route versus oral route

Objective To assess and compare the efficacy and safety of two and three doses of intravenous iron sucrose with daily oral ferrous sulphate in the prophylaxis of iron deficiency anaemia in pregnant women. Study design 260 women with singleton pregnancy who met inclusion criteria and who gave informed consent were randomised between the 21st and 24th week into either the intravenous iron group or the oral iron group. Of 130 women in the intravenous iron group, 75 women received two doses of 200 mg iron sucrose and 55 three doses of 200 mg iron sucrose. The first dose was administered between the 21st and 24th gestational weeks, the second between the 28th and 32nd and the third between the 35th and 37th. The women of the oral group were given oral tablets of 80 mg ferrous sulphate daily, beginning on the day of study enrolment and stopping on the day of delivery. Results There was a non-significant trend to a higher frequency of responders (haemoglobin ≥ 11 g/dl) in the intravenous iron group (75 vs. 80%). There was a significant difference of repleted iron stores before delivery (ferritin > 50 μg/l) in the group with three intravenous iron doses in comparison to the oral iron group (49 vs. 14%; p < 0.001). No differences were observed in regard to maternal and perinatal outcomes. Conclusions There was no clinically significant difference in the haematological, maternal and foetal outcomes in the parenteral route of iron prophylaxis in pregnant women.

Safety and Usefulness of Intravenous Iron Sucrose in the Management of Preoperative Anemia in Patients with Menorrhagia: A Phase IV, Open-Label, Prospective, Randomized Study

Background: The aim of this study was to compare the efficacy, safety and achievement of the target hemoglobin level (Hb ≥10 g/dl) in patients with preoperative anemia due to menorrhagia who received intravenous iron sucrose compared with oral iron protein succinylate for anemia management. Methods: Seventy-six patients with Hb levels <9.0 g/dl who were scheduled to undergo surgical treatment were randomized to receive either intravenous iron sucrose (based on the calculated total iron deficit divided into 2 ampoule infusions intravenously 3 times a week, beginning 3 weeks before surgery) or oral iron (80 mg/day of oral iron protein succinylate daily). Results: The intravenous iron group had higher increases in Hb (3.0 vs. 0.8 g/dl; p < 0.0001) and ferritin levels (170.1 vs. 4.1 μg/l; p < 0.0001) than the oral iron group. Achieving the target Hb was also higher in the intravenous iron group than in the oral iron group (76.7 vs. 11.5%; p < 0.0001). There were tolerable adverse events in both groups. Conclusion: Preoperative intravenous iron sucrose administration is more effective than oral iron and is as safe as oral iron therapy in the correction of preoperative anemia due to menorrhagia.

Intravenous iron sucrose is superior to oral iron sulphate for correcting anaemia and restoring iron stores in IBD patients: A randomized, controlled, evaluator-blind, multicentre study

Objective. Patients with inflammatory bowel disease (IBD) often have low iron stores or anaemia. There is controversy about whether iron should be supplemented orally or intravenously (i.v.). The purpose of this study was to investigate whether treatment with intravenous iron is superior to treatment with oral iron. The primary end-points were response and remaining anaemia at the end of treatment (EOT). Material and methods. Ninety-one patients with IBD and anaemia (B-Hb <115 g/L) were randomized to oral iron sulphate (n=46) or intravenous iron sucrose (n=45) treatment for 20 weeks. Results. Forty-three patients in the intravenous iron group completed the study compared to 35 patients in the oral iron group (p=0.0009). Only 22 patients (48%) tolerated the prescribed oral dose, and 52% reduced the dose or withdrew from treatment because of poor tolerance. At EOT, 47% patients in the oral iron group increased their B-Hb by ≥20 g/L, compared with 66% in the intravenous iron group (p=0.07). In the oral iron group, 41% still had anaemia versus 16% of the patients in the intravenous iron group (p=0.007), and 22% versus 42% reached their reference B-Hb level (p=0.04). Treatment with intravenous iron sucrose improved iron stores faster and more effectively than oral iron (p=0.002). Under treatment with intravenous iron, 74% of the patients had no anaemia and normal S-ferritin levels (>25 µg/L) at EOT compared with 48% of patients receiving oral iron (p=0.013). Conclusions. Treatment with intravenous iron sucrose is effective, safe, well tolerated and superior to oral iron in correcting haemoglobin and iron stores in patients with IBD.

Does quality of life improvement precede anemia correction in patients with chemotherapy-induced anemia treated with intravenous iron?

9082 Background: Combining intravenous (IV) iron with erythropoiesis-stimulating (ESA) therapy has been shown to increase Hgb response in treating anemia of cancer and chemotherapy. As part of a trial in anemic cancer patients on chemotherapy being treated with an ESA, we compared the effects of IV iron, oral iron, and no iron, on changes in patient-reported HRQOL. Methods: Prospective, randomized, controlled, multicenter trial. Major inclusions: pt starting chemotherapy cycle, Hb &lt;11g/dL, ferritin &gt;100 ng/mL or transferrin saturation &gt;15%. Major exclusions: recent transfusion, ESA, or IV iron use, infection. All pts received epoetin alfa (40,000 U SQ/Wk for first 4 wks, then dose- adjusted per protocol). Pts were randomized to: No iron, PO FeSO4 325 mg tid, or IV ferric gluconate 125 mg IV weekly, for 8 weeks. Change in HRQOL was measured 4 weeks after start and at end of study (week 10, or last observation carried forward) using Functional Assessment of Cancer Therapy (FACT)-Anemia. Results: There were no significant between-group differences at baseline in mean Hb (10.2g/dL), TSAT (31.3%), or serum ferritin (421ng/mL) for the 129 evaluable patients, (mean age 65.3, 69% female). See Table . Hgb responses were significantly greater by end of study in evaluable pts receiving IV FG than oral iron or no iron. Only pts receiving FG reported a significant improvement in FACT-Fatigue subscale (FACT-F). This difference began at 4 weeks, while Hgb response was still similar between groups. No significant improvement in fatigue was reported by either the no iron (ESA alone) nor oral iron group. Conclusions: Combining IV iron with ESA therapy lead to an early and sustained clinically significant (=3) improvement in fatigue score, which preceded the improvement in Hgb response. [Table: see text] [Table: see text]

Intravenous Ferric Gluconate (FG) for Increasing Response to Epoetin (EPO) in Patients with Anemia of Cancer Chemotherapy - Results of a Multicenter, Randomized Trial.

A significant proportion of cancer patients receiving chemorx will present with or develop anemia. The cause of this anemia is often the inflammatory cytokine-mediated anemia of chronic disease associated with cancer and/or chemorx. We conducted a prospective randomized controlled multicenter trial in anemic cancer patients on chemorx to see if no iron, oral iron, or IV iron, affects Hb response to EPO. Major inclusion criteria: pt about to start cycle of chemorx, eligible for EPO therapy, Hb <11 g/dL, with ferritin > 100 ng/mL and/or transferrin saturation (TSAT) >15%. Major exclusion criteria: recent transfusion, EPO or IV iron use, active infection, anemia from other causes. All pts received 40,000 U epoetin alfa SQ/Wk for first 4 wks, after which dose adjustments permitted for remainder of study period. All pts received cytotoxic chemorx. Pts returned weekly for 8-week treatment period with follow-up visits at wks 10 and 12. Safety population includes all pts exposed to study drug (n=187). Intent-to-treat (ITT) population is pts with at least 1 post-baseline Hgb evaluation prior to transfusion (n=180). Evaluable population consists of ITT pts with no major protocol deviations, who completed ≥7 weeks of the study, received at least 4 doses of EPO, and according to group, ≥ 7 doses of FG, or ≥67% of oral Fe (n=129). Treatment groups compared using ANCOVA model with multiple comparison adjustment. 187 Pts (69% female, mean age 64.4 yrs) were randomized to: no Fe, PO FeSO4 325 mg tid, or FG 125 mg iv weekly for 8 wks. Most common cancers were lung (29.9%) and breast (18.2%). There were no significant differences between groups in mean baseline Hb (10.2g/dL), TSAT (31.3%), serum ferritin (421 ng/mL), reticulocyte hemoglobin content (CHr, 34.2 pg). 95% of pts had baseline ferritin >100ng/mL. Efficacy results are presented for the Evaluable population. Oral iron compliance was excellent at 93.3% of tablets dispensed. 73% of the FG group achieved a Hb increase ≥2g/dL vs 46% for oral iron (p=.0099) and 41% for no iron groups (p=.0029). This difference was most pronounced in patients with baseline TSAT <20% (94% of whom had baseline serum ferritin >100ng/mL). Among these pts, FG group had 81% response rate vs oral iron 37% (p=.0091) and no iron pts 27% (p=.0027).Change from Baseline - Evaluable PopulationIV FGOral IronNo IronHb g/dL+2.4+1.6 p=.009+1.5 p=.004TSAT %−1.8−2.7−13.7Ferritin ng/mL+344−14 p<.0001−96 p<.0001CHr pg+2.1+1.4+0.3p values in comparison to FG groupOverall 93.6% of pts experienced at least 1 adverse event, evenly distributed among all 3 treatment groups. 19 pts (31.1%) in the oral iron group experienced a drug related adverse event, 4 leading to study discontinuation. 8 pts (12.7%) in the FG group experienced a drug related adverse event, 2 leading to discontinuation. In this study of anemic cancer patients on chemorx, all 3 groups responded to EPO therapy, but responses were significantly better in evaluable patients who received IV FG versus oral iron or no iron. Our data indicate FG allows the least iron restricted hematopoiesis and the best Hb responses, especially in patients with TSAT <20% and ferritin > 100, typical of anemia of chronic disease. IV FG was well tolerated.

A prospective, partially randomized study of pregnancy outcomes and hematologic responses to oral and intramuscular iron treatment in moderately anemic pregnant women

Daily oral iron supplementation during pregnancy fails to reduce the prevalence of anemia. However, 2 or 3 intramuscular doses of iron given at monthly intervals were recently found to be effective. We compared the safety and efficacy in treating pregnancy anemia of 3 intramuscular doses of iron given at monthly intervals with those of daily oral iron supplementation. In a prospective, partially randomized study, 148 pregnant women received daily oral doses of 100 mg elemental Fe and 500 micro g folic acid, and 106 pregnant women received 3 intramuscular doses of 250 mg elemental Fe as iron dextran at 1-mo intervals and oral doses of 5 mg folic acid twice weekly. One hundred women in each group completed the study. Changes in hemoglobin, iron indicators, pregnancy outcomes, and birth weight were compared between the 2 groups. Hemoglobin and iron indicators improved significantly with both treatments. The increase in serum ferritin concentration after parenteral iron treatment was significantly higher than that after oral iron treatment. No significant differences between the 2 groups in pregnancy outcomes and birth weight were observed. Systemic side effects were more common in the parenteral iron group, whereas gastrointestinal side effects were more common in the oral iron group. The intramuscular administration of 3 doses of 250 mg Fe at monthly intervals appears to have good compliance and efficacy and may be used in women who cannot tolerate oral administration of iron. However, intramuscular administration of iron is appropriate only in hospital settings well equipped to treat anaphylactic crises.

Correction of Uremic Iron Deficiency Anemia in Hemodialyzed Patients: A Prospective Study

This prospective study was designed to evaluate the eventual correction of anemia and iron status in 39 iron-deficient uremics starting hemodialysis. Nine patients (control group) had no iron supplementation, 10 had oral ferrous iron, and 20 were treated with intravenous iron gluconate. Follow-up periods were 12 months for the control group and 26 months for patients treated with oral or intravenous iron. No patient was treated with erythropoietin. At zero time, all patients were anemic (Hb <78 g/l) and showed signs of severe iron deficiency, diagnosed on the basis of depleted bone marrow iron stores, reduced hemoglobin iron, and transferrin saturation <21%. The hemoglobin levels, observed in patients of the control and the oral iron groups at the end of the follow-up periods, were not significantly different from those detected at zero time. In contradistinction, patients treated with intravenous iron showed after 26 months of follow-up a significant increase of blood hemoglobin values, reaching a mean value of 126 g/l. So far, this evidence supports both the concept that iron absorption is compromised in chronic uremics and that the parenteral way is the more effective route for iron replacement in this specific group of patients.

Experience of iron saccharate supplementation in haemodialysis patients treated with erythropoietin

We assessed the efficacy of intravenous (i.v.) iron saccharate (VENOFER) vs oral iron supplementation in haemodialysis patients treated with low‐dose erythropoietin (EPO). Twenty haemodialysis patients with serum ferritin &gt;200 ng/mL and transferrin saturation &gt;30% were assigned to one of the two groups. In Group 1, 10 were given i.v. iron saccharate (100 mg i.v. twice weekly) post dialysis. In Group 2, oral ferrous sulphate 200 mg was given thrice daily. In both groups, subcutaneous EPO 25 units/kg body weight (BW) was started simultaneously, twice weekly. After 3 months (study completion) the mean haemoglobin and haematocrit was significantly increased in Group 1 than in Group 2 (Hb 11.60±0.64 G/dL vs 10.5 G/dL±1.14 P&lt;0.01). The final mean EPO dose was 25% lower in Group 1 than in Group 2 (3400±1356 U/week vs 4600±1356 U/week P=0.10) and the mean serum ferritin was higher in the i.v. iron group than the oral group (671 ng/mL±388 vs 367 ng/mL±238 P=NS). The same was also observed with transferrin saturation (44.6%±19.8 in Group 1 vs. 29%±11.0 in Group 2 P=NS). No adverse effects were seen during the study. In conclusion, we observed that regular use of i.v. iron had a significantly enhanced haemoglobin response, better maintained serum ferritin and lower EPO dosage requirement than the oral iron group.

Experience of iron saccharate supplementation in haemodialysis patients treated with erythropoietin

SUMMARY: We assessed the efficacy of intravenous (i.v.) iron saccharate (VENOFER) vs oral iron supplementation in haemodialysis patients treated with low‐dose erythropoietin (EPO). Twenty haemodialysis patients with serum ferritin &gt;200 ng/mL and transferrin saturation &gt;30% were assigned to one of the two groups. In Group 1, 10 were given i.v. iron saccharate (100 mg i.v. twice weekly) post dialysis. In Group 2, oral ferrous sulphate 200 mg was given thrice daily. In both groups, subcutaneous EPO 25 units/kg body weight (BW) was started simultaneously, twice weekly. After 3 months (study completion) the mean haemoglobin and haematocrit was significantly increased in Group 1 than in Group 2 (Hb 11.60 ± 0.64 G/ dL vs 10.5 G/dL ± 1.14 P&lt;0.01). the final mean EPO dose was 25% lower in Group 1 than in Group 2 (3400 ± 1356 U/week vs 4600 ± 1356 U/week P=0.10) and the mean serum ferritin was higher in the i.v. iron group than the oral group (671 ng/mL ± 388 vs 367 ng/mL ± 238 P=NS). the same was also observed with transferrin saturation (44.6%± 19.8 in Group 1 vs. 29%± 11.0 in Group 2 P=NS). No adverse effects were seen during the study. In conclusion, we observed that regular use of i.v. iron had a significantly enhanced haemoglobin response, better maintained serum ferritin and lower EPO dosage requirement than the oral iron group.

Reduction in recombinant human erythropoietin doses by the use of chronic intravenous iron supplementation

We have compared the efficacy of oral to intravenous iron for the chronic maintenance of iron stores in hemodialysis patients. Fifty-two hemodialysis patients with initial serum ferritin greater than 100 ng/mL and transferrin saturation greater than 15% were randomly assigned to one of two groups: those receiving oral iron therapy (n = 32) and those receiving intravenous iron dextran (100 mg twice weekly) (n = 20). At study completion (4 months), the mean hematocrit was significantly higher in the intravenous group than in the oral iron group (34.4% ± 0.7% v 31.8% ± 0.4%, respectively; P < 0.05), the final mean recombinant human erythropoietin dose was 46% lower in the intravenous iron group than in the oral group (4,050 ± 634 U/treatment v 7,563 ± 378 U/ treatment; P < 0.05), and the mean serum ferritin was significantly higher in the intravenous group than in the oral iron group (753.9 ± 30.2 ng/mL v 157.3 ± 15.4 ng/mL, respectively; P < 0.05). We have found that administering iron intravenously instead of orally for chronic maintenance iron supplementation in hemodialysis patients resulted in improved erythropoiesis. We hypothesize that most hemodialysis patients have inadequate iron stores for optimal erythropoiesis when currently recommended levels of ferritin and transferrin saturation are used to guide therapy, and that the chronic use of intravenous iron could reduce recombinant human erythropoietin requirements by maximizing iron stores. The improvement in erythropoiesis was accompanied, however, by an increase in iron indices to levels that could be indicative of tissue iron overload. Future studies must be performed to determine whether lower doses of intravenous iron dextran would improve erythropoiesis without causing potential organ iron overload.

Comparison of intramuscular iron-dextran and oralferrous sulfate in the treatment of iron-deficiency anemia

Summary Seventy-two children with nutritionaliron-deficiency anemia were given iron-dextran complex intramuscularly. The average gain in hemoglobin in the first and second weeks after intramuscular therapy was 2.1 and 2.2 Gm. per cent in the 28 uncomplicated cases, 1.8 and 1.7 Gm. per cent in 19 cases complicated by infection, and 0.7 and 1.3 Gm. per cent in 9 cases complicated by lead poisoning. In 12 patients, with uncomplicated iron-deficiency anemia, receiving weekly injections, the gain for the first week was 1.4 Gm. per cent and 2.3 Gm. per cent for the second week. In the oral-iron group, this gain was about 1.0 Gm. per cent each week. Only one patient had staining of the skin at the site of injection. One patient developed urticaria after an iron-dextran injection. From these observations, it wouldappear that in situations where a rapid elevation of hemoglobin is important, injection of iron intramuscularly is desirable. Intramuscular iron also provides for a faster and surer way of replenishing depleted iron stores. Another indication for intramuscular iron is that of a careless mother who might not give the oral medication.