A randomized, controlled parallel‐group trial on efficacy and safety of iron sucrose (Venofer®) vs iron gluconate (Ferrlecit®) in haemodialysis patients treated with rHuEpo

Kosch, Markus; Bahner, Udo; Bettger, Helga; Matzkies, F; Teschner, Markus; Schaefer, Roland M.

doi:10.1093/ndt/16.6.1239

Cited by 79 publications

(59 citation statements)

References 14 publications

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“…In contrast to the above findings, several studies concluded that there was no increased infection rate resulting from iron therapy in patients without renal failure or in patients undergoing dialysis (41)(42)(43). Furthermore, in a study that compared effectiveness and safety of iron sucrose and iron gluconate, no difference was observed between these iron complexes (44).…”

Section: Discussionmentioning

confidence: 94%

Impairment of Transendothelial Leukocyte Migration by Iron Complexes

Sengoelge

Kletzmayr

Ferrara

et al. 2003

Journal of the American Society of Nephrology

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Abstract. Although iron sucrose and iron gluconate are generally well tolerated in patients who are treated for renal anemia, recent clinical studies and cell culture experiments suggested significant toxicity and long-term side effects arising from the use of these iron complexes. Because of the possible role of iron in infection or cardiovascular disease, it was theorized that parenteral iron compounds influence endothelial and PMN interaction in vitro. A well-established double-chamber method was used to assess the effect of different concentrations of iron sucrose and iron gluconate (1, 25, 50, and 100 g/ml) on the transendothelial migration of PMN. Preincubation of PMN and endothelial cells as well as preincubation of PMN alone with 25, 50, or 100 g/ml iron resulted in a significant decrease in PMN migration. In contrast, after incubation of the endothelial cells alone with iron, no reduction in the transendothelial migration of PMN was observed. Preincubation of PMN and/or endothelial cells with 1 g/ml iron did not lead to any decrease in the rate of migrated PMN. The only significant change in experiments with 1 g/ml was an increase in PMN migration after preincubation of endothelial cells and PMN with iron gluconate. A four-way ANOVA showed a significant effect of the iron concentration (P Ͻ 0.000001), of type of iron complex (P Ͻ 0.005), of the preincubation of endothelial cell (P Ͻ 0.001), and of the preincubation of PMN with iron (P Ͻ 0.000001) on PMN diapedesis. It is concluded that iron sucrose and iron gluconate cause a significant inhibition of transendothelial migration of PMN.Renal anemia therapy requires an intravenous iron substitution in addition to the erythropoietin therapy in the majority of patients (1). Iron substitution not only reduces the erythropoietin dosage needed but also is necessary to maintain the target hemoglobin above 11 g/dl (2,3). There are several iron preparations for intravenous use available, all of which have potential side effects, such as allergic reactions, cell injury, or endothelial dysfunction (4 -7). Moreover, iron therapy may be associated with infectious complications and with loss of the ability of patient serum to resist the bacterial growth (8 -10). PMN play a vital role in the nonspecific immune reaction against bacterial infections executing functions such as chemotaxis, transendothelial migration, phagocytosis, and intracellular killing by proteolytic enzymes or toxic oxygen radicals. Although the effects of iron on chemotaxis of PMN, phagocytosis, and intracellular killing in PMN were studied previously, the effect of iron complexes on PMN-endothelial cell interaction is unknown. Therefore, we examined the effect of incubation of PMN and/or endothelial cells with two widely used iron complexes, iron(III)-hydroxide-sucrose complex (iron sucrose) and iron(III)-sodium-gluconate in sucrose (iron gluconate), on the PMN migration through the endothelium in an in vitro setting.

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Section: Discussionmentioning

confidence: 94%

Impairment of Transendothelial Leukocyte Migration by Iron Complexes

Sengoelge

Kletzmayr

Ferrara

et al. 2003

Journal of the American Society of Nephrology

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“…The low frequency of side effects of iron gluconate and particularly iron sucrose was mentioned in previous trials [7,8]. Nevertheless, higher doses of iron gluconate caused complications such as chills, severe vomiting, hypotension, and syncope [9].…”

Section: Discussionmentioning

confidence: 93%

Intravenous iron in a primary‐care clinic

Maslovsky¹

2005

American J Hematol

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The preferable route of iron delivery for most iron-deficient patients is oral. Parenteral iron therapy is used in patients who cannot tolerate oral iron or in cases in which oral iron is not sufficiently effective. The most frequent indications for parenteral iron therapy are unbearable gastrointestinal side effects induced by oral iron itself, worsening of inflammatory bowel disease symptoms, insufficient intestinal absorption, renal failure-caused anemia that is treated with erythropoietin, and unresolved ongoing bleeding, which would cause the acceptable oral doses of iron therapy to be exceeded. The serious adverse effects of iron dextran that was used in the past could explain the reluctance of medical personnel to prescribe this effective treatment. Patients with iron deficiency anemia were treated with intravenous iron in a primary care clinic. The iron gluconate was given in a dosage of 62.5 mg diluted in 150 mL of normal saline and was infused intravenously over 30 min, while iron sucrose was given in a dosage of 100 mg diluted in the same volume of normal saline and given at the same rate. In total, 724 infusions were administered to 57 patients. Iron sucrose was used in 628 infusions, and iron gluconate was used in the remaining 96. The frequency of the infusion treatments depended on the underlying disease and ranged from three times a week to once a month. Adverse effects were seldom observed and were minor in patients receiving iron gluconate, and were not registered at all in patients treated with iron sucrose. Two cases of flushing with paresthesias occurred. Slowing the infusion rate successfully eliminated these side effects. One case of hypotension was treated successfully with 500 cc of normal saline infusion. One case of dropout occurred, due to the patient's refusal to cooperate. No anaphylactic reactions were observed. Iron gluconate and iron sucrose are effective and safe for use in primary care clinics. The risk of adverse effects is low. Am.

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“…Despite study shortcomings and lack of definitive randomized trials, the iron sucrose Venofer and the iron gluconate Ferrlecit are believed to have lower risks of serious anaphylactic-type reactions than the iron dextrans [20][21][22][23][24][25][26][27] possibly because they do not initiate an anti-dextran response [25]. A stated advantage of iron dextran, besides lower cost, is the ability to infuse a patient's total iron requirement in one administration (total dose infusion) [28][29][30] so clinicians can conveniently treat patients in a single hospital or clinic visit.…”

Section: Discussionmentioning

confidence: 99%

Use of parenteral iron products and serious anaphylactic‐type reactions

Wysowski¹,

Swartz²,

Borders-Hemphill³

et al. 2010

American J Hematol

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Controversy exists about the safety of the parenteral iron dextran products, Dexferrum and INFeD, which have been associated with rare, serious anaphylactic-type reactions. In the United States, their product labels carry boxed warnings of this adverse event; some have called for the withdrawal from marketing of the higher molecular weight Dexferrum. Between 2002 and 2007, sales of Dexferrum, INFeD, and iron gluconate Ferrlecit declined 32.5%, 21%, and 4.8%, respectively, while sales of iron sucrose Venofer increased 160%. Voluntary reports submitted to the Food and Drug Administration show anaphylactic reactions and symptoms for the four parenteral iron products. Because of underreporting, possible differential reporting, absence of iron dextran brand names, and incomplete use (denominator) data, incidence rates and relative risk estimates cannot be calculated. U.S. death certificate data show that for most years from 1979 through 2006, no more than 3 deaths per year were coded to ''adverse events in therapeutic use of iron preparations;'' brand names were not consistently recorded. Emergency department data show small numbers of visits for treatment of allergic reactions with intravenous iron preparations. The data presented herein show that allergic reactions are possible with all four parenteral iron products, and it is difficult to determine which product has the largest risk based on sales data, voluntarily submitted adverse event reports, death certificates, ED visits, and observational studies performed to date. To help differentiate risk among the parenteral iron products, the brand name of the product always should be provided on medical records, death certificates, and adverse drug reaction reports. Am. J.

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A randomized, controlled parallel‐group trial on efficacy and safety of iron sucrose (Venofer®) vs iron gluconate (Ferrlecit®) in haemodialysis patients treated with rHuEpo

Abstract: High doses of iron sucrose (Venofer((R)) at a dose of 250 mg/month) was equally effective in maintaining haemoglobin and equally well tolerated as low doses of iron gluconate (Ferrlecit((R)) at a dose of 62.5 mg once per week) in stable, rHuEpo treated haemodialysis patients.

Cited by 79 publications

References 14 publications

Impairment of Transendothelial Leukocyte Migration by Iron Complexes

Impairment of Transendothelial Leukocyte Migration by Iron Complexes

Intravenous iron in a primary‐care clinic

Use of parenteral iron products and serious anaphylactic‐type reactions

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