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PubMed2003

The safety and efficacy of an accelerated iron sucrose dosing regimen in patients with chronic kidney disease.

BACKGROUND: Provision of adequate iron to support erythropoiesis in patients with chronic kidney disease (CKD) is time consuming and may present adherence problems for patients in the outpatient setting. We studied an accelerated regimen of high-dose intravenous iron sucrose therapy in a cohort of iron-deficient, anemic CKD patients. METHODS: Intravenous iron sucrose 500 mg was infused over three hours on two consecutive days in 107 CKD patients (glomerular filtration rate, 32.3 +/- 19.6 mL/min/1.73m2, baseline hemoglobin 10.2 +/- 1.7 g/dL). Iron indices (transferrin saturation, ferritin) were measured at baseline and at two and seven days after completion of the iron regimen. Blood pressures were monitored immediately prior to, and hourly throughout the iron sucrose infusions. RESULTS: Transferrin saturation and serum ferritin increased from 18.5 +/- 8.5% and 177 +/- 123.8 ng/mL at baseline to 40.2 +/- 22.3% and 811 +/- 294.1 ng/mL in 102 evaluated patients (P < 0.015). In 55 patients with additional measurements at 7 days post-dosing, the transferrin saturation and ferritin had fallen to 26.3 +/- 10.6% and 691 +/- 261.8 ng/mL (P < 0.015 compared to two days' post-dose). Blood pressure rose slightly, but not significantly, throughout the infusions, and altering the infusion rate was not necessary. Two patients had seven adverse events that were considered related to iron sucrose. CONCLUSION: An accelerated regimen of high-dose intravenous iron sucrose therapy in CKD patients is safe and effective in restoring iron stores, and may potentially save time and improve patient adherence.

Aged↗
PubMedDate not supplied

The comparative safety of intravenous iron dextran, iron saccharate, and sodium ferric gluconate.

Intravenous iron treatment is an important component of anemia therapy for patients on dialysis. Until recently iron dextran was the only parenteral form of iron available in the United States. This drug has been associated with occasional serious adverse reactions, including full-blown anaphylaxis. In 1999 the Food and Drug Administration approved a second form of iron for intravenous administration, sodium ferric gluconate in sucrose. It is expected that by the time of this publication, a third agent, iron saccharate will also be approved. In this review the comparative safety of these three agents is critically evaluated.

Anemia↗
PubMed2001

Risk of bacterial infection in patients under intravenous iron therapy: dose versus length of treatment.

Some studies have suggested that intravenous iron therapy may be associated with an increased risk of infection. We analyzed the incidence of bacterial infection in 111 hemodialysis patients. Group 1 (n = 39, transferrin saturation <20%) received 10 doses of 100 mg of intravenous iron saccharate, 3 doses per week (28 treatment days); Group 2 (n = 13, transferrin saturation <20%) received 20 doses, 3 doses per week (70 treatment days); and Group 3 (n = 59, transferrin saturation 20-50%) received 10 doses, 1 dose per week (70 treatment days). The follow-up was 150 days for all groups, and all infectious episodes were recorded. Pulmonary infection was the most frequent event observed in all of the groups. In an incidence-density analysis, Group 2, which received a total of 20 doses, presented a significantly higher incidence of infection than Group 3, which received only 10 doses over the same period (0.13 versus 0.06 infections per patient per month, p = 0.04). No difference was observed between Groups 1 and 2 suggesting that the risk of infection during iron therapy is dose dependent rather than time length dependent.

Adult↗
PubMed1999

Oral or intravenous iron as an adjuvant to autologous blood donation in elective surgery: a randomized, controlled study.

BACKGROUND: This study was performed to evaluate the capacity of oral and intravenous (i.v.) iron administration during autologous blood donation (ABD) to improve the efficacy of ABD and to prevent the need for allogeneic blood transfusion in patients without iron deficiency who are undergoing major elective surgery for which a minimum of 3 autologous units have been ordered. STUDY DESIGN AND METHODS: One hundred twenty-three patients were enrolled in an open-labeled, randomized, controlled trial and assigned to three treatment groups: patients in Group 1 received 3 x 100 mg of Fe2+ per day given orally for 5 weeks before operation; patients in Group 2 received 200 mg of Fe3+ given intravenously after each donation combined with initial i.v. iron supplementation in patients with hemoglobin under 15 g per dL; and patients in Group 3 were in the control group that received no iron medication. A modest ABD program involving weekly phlebotomy and threshold hemoglobin values for donation of 11.5 g per dL in women and 12.0 g per dL in men was performed. RESULTS: Ninety patients, 15 women and 15 men in each of the three groups, completed the study. The mean net red cell production during ABD was no higher (p>0.2) in the iron-treated groups (Group 1: 473 +/- 178 mL; Group 2: 436 +/- 170 mL; Group 3 (controls): 397 +/- 174 mL). The mean number of autologous units donated per patient did not differ (p>0.7) among the groups (Group 1: 3.1 +/- 0.6; Group 2: 2.9 +/- 0.7; Group 3: 3.0 +/- 0.7). The proportion of patients who needed allogeneic blood transfusion showed no significant (p>0.4) advantage for iron treatment, (Group 1: 7%; Group 2: 20%; Group 3: 10%). CONCLUSION: In non-iron-deficient patients undergoing modest ABD without erythropoietin therapy, neither oral nor i.v. application of iron during the preoperative period enhances the success of preoperative ABD.

Administration, Oral↗
PubMed2000

Safety and efficacy of iron sucrose in patients sensitive to iron dextran: North American clinical trial.

Sensitivity to iron dextran is a potent obstacle to maintaining optimum iron status in patients with dialysis-associated anemia. As part of the North American clinical trials for iron sucrose injection, we examined the effect of intravenous (IV) iron sucrose in 23 hemodialysis patients with documented sensitivity to iron dextran, ongoing epoetin alfa therapy, and below-target-range hemoglobin (Hgb) levels (<11.0 g/dL). We assigned patients to treatment groups according to whether reactions they had experienced to iron dextran were judged to be mild (n = 16; group A) or severe (n = 7; group B). We prospectively examined adverse events and vital signs after administering 100 mg of IV iron sucrose in each of 10 consecutive dialysis treatment sessions and compared results with those recorded in each of three consecutive dialysis sessions without iron treatment. We administered iron sucrose by IV push over 5 minutes to group A patients and by IV push over 5 minutes or IV infusion over 15 to 30 minutes to group B patients. We did not administer a test dose. Results showed no serious adverse drug reactions after a total of 223 doses of iron sucrose (184 doses by IV push, 39 doses by IV infusion). Intradialytic blood pressure changes after IV iron sucrose injection did not differ from those recorded during dialysis sessions without treatment. An increase in values for Hgb, hematocrit, transferrin saturation, and ferritin, coupled with no significant change in epoetin dose and a decrease in total iron-binding capacity, confirmed the efficacy of iron sucrose injection in managing anemia. We conclude that iron sucrose injection is safe and effective in the management of anemia in patients sensitive to iron dextran and can be administered without a test dose by IV push or infusion.

Anemia, Iron-Deficiency↗
PubMed2001

Efficacy and safety of iron sucrose for iron deficiency in patients with dialysis-associated anemia: North American clinical trial.

Iron sucrose has been used to provide intravenous (IV) iron therapy to patients outside the United States for more than 50 years. In a multicenter North American clinical trial, we determined the efficacy and safety of iron sucrose therapy in patients with dialysis-associated anemia, evidence of iron deficiency, and below-target hemoglobin (Hgb) levels despite epoetin therapy. Evidence of iron deficiency included a transferrin saturation (Tsat) less than 20% and ferritin level less than 300 ng/mL, and below-target Hgb levels included values less than 11.0 g/dL. We administered iron sucrose in 10 doses, each administered undiluted as 100 mg IV push over 5 minutes, without a prior test dose. We assessed efficacy by determining the subsequent change in Hgb, Tsat, and ferritin values. We assessed safety by recording blood pressure and adverse events after iron sucrose injection and comparing results with those for the same patients during an observation control period. Results showed a significant increase in Hgb level that was first evident after three doses of iron sucrose and persisted at least 5 weeks after the 10th dose. Tsat and ferritin levels also increased significantly and remained elevated. In 77 enrolled patients, including those with previous iron dextran sensitivity, other drug allergies, or concurrent angiotensin-converting enzyme inhibitor use, we saw no serious adverse drug reactions and no change in intradialytic blood pressure associated with iron sucrose administration. We conclude that iron sucrose injection administered as 1,000 mg in 10 divided doses by IV push without a prior test dose is safe and effective for the treatment of iron deficiency in patients with dialysis-associated anemia.

Aged↗
PubMed2002

Induction of protein oxidation by intravenous iron in hemodialysis patients: role of inflammation.

BACKGROUND: Oxidative stress and inflammation contribute to the high prevalence and severity of atherosclerosis, infections, and beta2-microglobulin amyloidosis; and thus, to reduced survival rate and quality of life in hemodialysis (HD) patients. Inflammation induces oxidative stress by production of the oxidants: superoxide anion, hydrogen peroxide, and hypochlorite. Intravenous iron (IVIR), administered in HD patients to correct anemia, can release free iron, that may react with hydrogen peroxide to produce the strong oxidant hydroxyl radical. Inflammation-induced lipid and protein oxidation and IVIR-induced lipid oxidation were shown in HD patients. However, IVIR-induced protein oxidation and a relationship between inflammation and IVIR-induced oxidative stress have not been reported to date. METHODS: We examined the effect of IVIR administration on markers of protein oxidation in HD patients (advanced oxidation protein products [AOPPs], thiol, and dityrosine) in relation to such inflammatory markers as C-reactive protein (CRP) and tumor necrosis factor-alpha (TNF-alpha). Iron saccharate, 100 mg, was administered to 19 HD patients for 1 hour after 3.5 hours of high-flux dialysis. Blood samples were drawn pre-HD, pre-IVIR, and post-IVIR for iron, transferrin, TNF-alpha, AOPP, thiol, total antioxidant capacity (TEAC), and dityrosine levels and pre-HD for ferritin and CRP levels. RESULTS: IVIR administration induced a 37% increase in AOPP level (P < 0.001), which correlated positively with pre-HD CRP level (r = 0.72; P < 0.05) and was greater in patients with a greater pre-HD TNF-alpha level (P < 0.05). IVIR administration did not affect TEAC, thiol, dityrosine, or TNF-alpha levels. CONCLUSION: IVIR administration induced an increase in protein oxidation (AOPP levels) that was related to the degree of inflammation.

Aged↗
PubMed2002

Iron sucrose: the oldest iron therapy becomes new.

Several parenteral iron preparations are now available. This article focuses on iron sucrose, a hematinic, used more widely than any other for more than five decades, chiefly in Europe and now available in North America. Iron sucrose has an average molecular weight of 34 to 60 kd, and after intravenous (IV) administration, it distributes into a volume equal to that of plasma, with a terminal half-life of 5 to 6 hours. Transferrin and ferritin levels can be measured reliably 48 hours after IV administration of this agent. Iron sucrose carries no "black-box" warning, and a test dose is not required before it is administered. Doses of 100 mg can be administered over several minutes, and larger doses up to 300 mg can be administered within 60 minutes. The efficacy of iron sucrose has been shown in patients with chronic kidney disease (CKD) both before and after the initiation of dialysis therapy. Iron sucrose, like iron gluconate, has been associated with a markedly lower incidence of life-threatening anaphylactoid reactions and may be administered safely to those with previously documented intolerance to iron dextran or iron gluconate. Nonanaphylactoid reactions, including non-life-threatening hypotension, nausea, and exanthema, also are extremely uncommon with iron sucrose. Management of patients with the anemia of CKD mandates that we carefully examine the effectiveness and safety of this oldest of iron preparations and the accumulating present-day data regarding it and contemporaneous agents.

Chronic Disease↗
PubMed2003

Chronic use of sodium ferric gluconate complex in hemodialysis patients: safety of higher-dose (> or =250 mg) administration.

BACKGROUND: Almost all hemodialysis (HD) patients require intravenous iron therapy to correct their anemia and maintain their iron stores. Sodium ferric gluconate complex (SFGC) is approved by the Food and Drug Administration (FDA) for treatment of iron deficiency anemia in HD patients at individual doses up to 125 mg over 10 minutes (12.5 mg/min) and has been shown to have a superior safety profile compared with iron-dextran. Higher individual doses of SFGC would permit more rapid repletion of iron stores and greater flexibility in maintenance iron therapy as well as simplify treatment of peritoneal dialysis patients and chronic kidney disease patients. METHODS: The authors reviewed the safety and tolerability of higher-dose SFGC infusions (> or =250 mg) in 144 HD patients who were previously tolerant to a single 125-mg dose of SFGC. These 144 patients received a total of 590 doses of > or =250 mg of SFGC; 571 doses were 250 mg SFGC, and most of these were infused over 1 hour, an infusion rate of 4.17 mg/min. The other 19 doses were 312.5 mg (n = 1), 375 mg (n = 14), and 500 mg (n = 4). Infusion rates varied from 1.22 mg/min to 25.0 mg/min. RESULTS: Only one patient was considered intolerant to higher-dosing SFGC after having pruritus after a second 250-mg dose of SFGC. Three patients had nonserious events that did not preclude further dosing of SFGC. CONCLUSION: Administration of 250 mg SFGC over 1 hour is safe and well tolerated. Individual doses of 375 mg and 500 mg SFGC also were well tolerated, but further research and experience are needed to confirm the safety and tolerance of these doses.

Anemia, Iron-Deficiency↗
PubMed2005

Administration of intravenous iron sucrose as a 2-minute push to CKD patients: a prospective evaluation of 2,297 injections.

BACKGROUND: Intravenous iron supplementation is an integral part of the management of anemia in patients with chronic kidney disease. Traditionally, this has been administered as an infusion over 1 or more hours, which requires the use of intravenous fluids and administration tubing, along with extra demands on patient and nursing time. METHODS: We prospectively investigated the safety and practicality of administering iron sucrose, 200 mg, as a bolus injection over 2 minutes in patients with chronic kidney disease. A total of 2,297 injections were administered to 657 patients. Any adverse events were recorded, including acute anaphylactoid reactions to the iron injection, along with the presence or absence of metallic taste and phlebitis, and these were classified as "serious" and "nonserious." RESULTS: The most common adverse event was a mild and transient metallic taste that occurred during 412 injections (17.9%); in no case was this of significant distress to the patient. Excluding this, 2,240 injections (97.5%) proceeded uneventfully, and no case of phlebitis was recorded. Adverse events other than metallic taste were recorded in association with 57 injections (2.5%). Seven of these were caused by an acute anaphylactoid reaction to the intravenous iron. All 7 acute reactions resolved completely within 30 minutes with no sequelae, and none required hospitalization. The remaining 50 adverse events consisted of pain during the injection (n = 31), pain after the injection with or without some bruising (n = 9), nausea/gastrointestinal symptoms (n = 3), lethargy (n = 4), and lightheadedness (n = 3). CONCLUSION: Administration of 200 mg of iron sucrose as an intravenous bolus injection over 2 minutes is a practical dosing regimen in patients with chronic kidney disease, resulting in considerable savings in time and cost.

Adult↗
PubMed2005

Trends in intravenous iron use among dialysis patients in the United States (1994-2002).

BACKGROUND: Two new intravenous (IV) iron products, ferric gluconate and iron sucrose, recently were approved for use in the United States. We report trends in IV iron use in both incident (1994 to 2001) and prevalent (1994 to 2002) Medicare US dialysis patients. METHODS: Included patients had Medicare as a primary payer. Recombinant human erythropoietin doses, IV iron use, and hemoglobin data were obtained from Medicare outpatient files. The most recent cohorts included 241,770 prevalent hemodialysis (HD) patients in 2002 and 11,744 incident HD patients in 2001. RESULTS: For incident HD patients in the first 9 months of dialysis therapy, the percentage of patients administered IV iron increased sharply between 1994 and 1997 and then increased gradually between 1997 and 2001. In 2002, a total of 84.4% of HD and 19.3% of peritoneal dialysis (PD) patients were administered IV iron. Ferric gluconate use increased slowly in 2000, increased from 5.7% to 18.6% from December 2000 to January 2001, increased to 29.8% in April 2002, and was 23.3% in December 2002. Iron sucrose use increased to 26% by December 2002. The absolute monthly percentage of HD patients administered IV iron dextran decreased from 49.6% in January 2000 to 3.6% in December 2002. CONCLUSION: In US patients with end-stage renal disease, IV iron use has increased, although slowly, from 1997 to 2002. Ferric gluconate and iron sucrose have become the predominant form of therapy. IV iron therapy was used in a much smaller percentage of PD compared with HD patients, and racial and geographic variability was observed.

Adolescent↗
PubMed2002

Tolerance and efficacy of intravenous iron saccharate for iron deficiency anemia in children and adolescents receiving long-term parenteral nutrition.

UNLABELLED: The aim of this study was to evaluate the safety and efficacy of intravenous iron saccharate administration in iron-deficient anemic children, under long-term parenteral nutrition, who are unable to tolerate oral iron supplementation or are unresponsive to oral supplementation because of gastrointestinal dysfunction or iron malabsorption. METHODS: Twenty-two infants and children aged 5 months-17 years (median: 38 months) receiving long-term parenteral nutrition and presenting with iron deficiency anemia were included. Total iron to be infused was determined by the formula: total iron (mg) = 0.6 x W (100 - Hb x 100/12) (W: weight, Hb: hemoglobin). Intravenous iron saccharate was given at the hospital. Each patient received a test dose of 25 mg of iron saccharate prior to the initiation of the infusion. Hemoglobin values, reticulocytes count, serum iron, and serum ferritin were determined before iron administration (day 1), as well as 15 and 45 days after iron administration. RESULTS: Tolerance of intravenous iron saccharate was good except in one patient who developed transient exanthema and hypotension after completion of the last iron saccharate infusion. Intravenous iron led to a significative increase in hemoglobin concentration of 2.2 g/dl within 45 days (range: 0.4-4.3 g/dl). CONCLUSION: Intravenous iron supplementation with iron saccharate is an efficient procedure, replenishing iron body stores and significantly increasing the hemoglobin concentration. The possible occurrence of allergic reactions emphasizes the need for close medical supervision.

Adolescent↗
PubMed2004

A study for the evaluation of safety and tolerability of intravenous high-dose iron sucrose in patients with iron deficiency anemia due to gastrointestinal bleeding.

INTRODUCTION: The provision of adequate iron to support erythropoiesis in iron deficient patients is a time-consuming process which may present compliance problems for patients in the outpatient setting. The aim of the present study was to evaluate the safety and tolerability of intravenous high-dose iron sucrose therapy specifically in patients with iron deficiency anemia (IDA) due to gastrointestinal blood loss. METHODS: A single dose of iron sucrose of 7 mg iron/kg body weight (not exceeding 500 mg) was infused over 3.5 hours in 31 consecutive patients with IDA due to gastrointestinal blood loss. Safety and tolerability of the therapy was assessed by the occurrence of adverse events under therapy and up to one week after completion of the study. Further examinations comprised vital parameters, ECG, and clinical chemistry including iron indices. RESULTS: A total of 14 adverse events were observed in 10 patients, of which two adverse events in two patients were considered as being definitely related to drug administration. None of the patients had to be withdrawn from therapy. Significant changes in vital parameters and ECG during therapy and follow-up were not observed and clinical chemistry remained unchanged. DISCUSSION: A single intravenous high-dose iron sucrose therapy in patients with IDA due to gastrointestinal blood loss appears to be safe and therefore is a therapeutic option which may save time and improve patient compliance.

Adult↗
PubMed2001

Efficacy and safety of intravenously administered iron sucrose with and without adjuvant recombinant human erythropoietin for the treatment of resistant iron-deficiency anemia during pregnancy.

OBJECTIVE: This study was undertaken to determine the efficacy and safety of intravenously administered iron sucrose with versus without adjuvant recombinant human erythropoietin in the treatment of gestational iron-deficiency anemia resistant to therapy with orally administered iron alone. STUDY DESIGN: Forty patients with gestational iron-deficiency anemia were randomly assigned to receive intravenously iron sucrose plus recombinant human erythropoietin or iron sucrose alone twice weekly. Target hemoglobin value was 11.0 g/dL. Efficacy measures were reticulocyte count, increase in hematocrit, and time to target hemoglobin level (treatment duration in weeks and need for continued therapy after 4 weeks). RESULTS: Both regimens were effective, but with adjuvant recombinant human erythropoietin the reticulocyte counts were higher from day 4 (P<.01), increases in hematocrit were greater from day 11 (P <.01), and the median duration of therapy was shorter (18 vs 25 days), with more patients reaching the target hemoglobin level by 4 weeks of treatment (n = 19 vs. n = 15). The groups did not differ with respect to maternal-fetal safety parameters. CONCLUSION: Adjuvant recombinant human erythropoietin safely enhanced the efficacy of iron sucrose in the treatment of gestational iron-deficiency anemia resistant to orally administered iron alone.

Anemia, Iron-Deficiency↗
PubMed2002

Iron therapy in iron deficiency anemia in pregnancy: intravenous route versus oral route.

OBJECTIVE: The aim of this study was to compare intravenous iron sucrose versus oral iron sulfate in anemia at 6 months of pregnancy. STUDY DESIGN: A random, prospective, open study with individual benefit was performed involving 50 patients with hemoglobin levels between 8 and 10 g/dL and a ferritin value of <50 microg/L. In the intravenous group (IV group), the iron dose was calculated from the following formula: Weight before pregnancy (kg) x (120 g/L - Actual hemoglobin [g/L]) x 0.24 + 500 mg. The oral group (PO group) received 240 mg of iron sulfate per day for 4 weeks. Treatment efficacy was assessed by measurement of hemoglobin and reticulocytes on days 8, 15, 21, and 30 and at delivery and of ferritin on day 30 and at delivery. The baby's birth weight and iron stores were noted. Results were expressed as median +/- interquartile range. Mann-Whitney and Wilcoxon tests were used for the analysis, with P <.05 considered significant. RESULTS: An increase in hemoglobin was observed, rising from 9.6 +/- 0.79 g/dL to 11.11 +/- 1.3 g/dL on day 30 in the IV group and from 9.7 +/- 0.5 g/dL to 11 +/- 1.25 g/dL on day 30 in the PO group (not significant). On day 30 (P <.0001) and at delivery (P =.01) ferritin was higher in the IV group. A mean higher birth weight of 250 g was noted in the IV group (not significant). CONCLUSION: Iron sucrose appears to be a treatment without serious side effects indicated in correction of pregnancy anemia or iron stores depletion.

Administration, Oral↗
PubMed1969

The effect of pressure on the oxidation state of iron, iv. Thiocyanate and isothiocyanate ligands.

The effect of pressure on the Mössbauer resonance spectra of Fe(III) with thiocyanate (M-SCN) and isothiocyanate (M-NCS) ligands has been studied. Fe(NCS)(3).6H(2)O, which has the isothiocyanate structure, reduces with increasing pressure, reversibly, and with a pressure dependence for the conversion very similar to that shown by a wide variety of ionic ferric compounds. K(3)Fe(SCN)(6) has the thiocyanate structure. At low pressures, it exhibits a significantly larger reduction than the Fe(NCS)(3). With increasing pressure the thiocyanate complexes isomerize, each complex apparently exhibiting about the same degree of conversion at a given pressure. At 150 kb the isomerization is essentially complete. The reduction of the Fe(III) to Fe(II) is reversible but the isomerization is not, and the sample, when powdered and reloaded in the high-pressure cell, exhibits the isomer shift, quadrupole splitting, and Fe(III) to Fe(II) conversion characteristic of an isothiocyanate. Heating the thiocyanate to 110 degrees C at 5 kb yields a mixture of thiocyanate and isothiocyanate that converts with pressure completely to the isothiocyanate.

Journal Article↗