Randomized cross-over study of adverse reactions and cost implications of intravenous push compared with infusion of iron dextran in hemodialysis patients

Peter, Wendy L. St.; Lambrecht, Lawrence J.; Macres, Mark

doi:10.1016/s0272-6386(96)90462-x

Cited by 35 publications

(18 citation statements)

References 3 publications

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“…50 The ability to administer ferumoxytol safely at high dosages without dilution or infusion may also save nursing time and the cost of disposables incurred with multiple infusions. 51 The results of this study emphasize key anemia management principles in patients with CKD stages 1 to 5. First, intravenous iron therapy is more effective than oral iron for increasing hemoglobin levels.…”

Section: Discussionmentioning

confidence: 62%

Ferumoxytol for Treating Iron Deficiency Anemia in CKD

Spinowitz

Kausz²,

Baptista³

et al. 2008

Journal of the American Society of Nephrology

229

174

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Iron deficiency is an important cause of anemia in patients with chronic kidney disease (CKD), but intravenous iron is infrequently used among patients who are not on dialysis. Ferumoxytol is a novel intravenous iron product that can be administered as a rapid injection. This Phase III trial randomly assigned 304 patients with CKD in a 3:1 ratio to two 510-mg doses of intravenous ferumoxytol within 5 Ϯ 3 d or 200 mg of elemental oral iron daily for 21 d. The increase in hemoglobin at day 35, the primary efficacy end point, was 0.82 Ϯ 1.24 g/dl with ferumoxytol and 0.16 Ϯ 1.02 g/dl with oral iron (P Ͻ 0.0001). Among patients who were not receiving erythropoiesis-stimulating agents, hemoglobin increased 0.62 Ϯ 1.02 g/dl with ferumoxytol and 0.13 Ϯ 0.93 g/dl with oral iron. Among patients who were receiving erythropoiesis-stimulating agents, hemoglobin increased 1.16 Ϯ 1.49 g/dl with ferumoxytol and 0.19 Ϯ 1.14 g/dl with oral iron. Treatment-related adverse events occurred in 10.6% of patients who were treated with ferumoxytol and 24.0% of those who were treated with oral iron; none was serious. In summary, a regimen of two doses of 510 mg of intravenous ferumoxytol administered rapidly within 5 Ϯ 3 d was well tolerated and had the intended therapeutic effect. This regimen may offer a new, efficient option to treat iron deficiency anemia in patients with CKD.

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Section: Discussionmentioning

confidence: 62%

Ferumoxytol for Treating Iron Deficiency Anemia in CKD

Spinowitz

Kausz²,

Baptista³

et al. 2008

Journal of the American Society of Nephrology

229

174

View full text Add to dashboard Cite

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“…One study showed that administration of intravenous iron as a bolus compared to an infusion could have led to an annual cost savings of USD 223,529 (USD 19.22 per dose) in the representative dialysis program studied [44]. Additionally, the ability to administer a repletion course of intravenous iron in fewer doses has significant cost and convenience benefits in hemodialysis patients, and especially in patients not yet on dialysis or those on peritoneal dialysis.…”

Section: Discussionmentioning

confidence: 99%

“…The group that received two divided doses showed a 35% cost savings (USD 965 vs. 1,490), in addition to three trips less to the clinic, fewer hours lost from work and personal time, and less travel expense. Despite apparent safety benefits over iron dextran, iron gluconate and iron sucrose preparations are limited by rate of administration and total dose-related reactions that may limit or preclude use of such convenient and cost-saving dosing regimens [21, 44, 45]. …”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetic Study of Ferumoxytol: A New Iron Replacement Therapy in Normal Subjects and Hemodialysis Patients

et al. 2005

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Background: Currently available intravenous iron preparations are not ideal, either because of safety concerns or dose limitations. We investigated the safety and pharmacokinetics of ferumoxytol, a new iron replacement therapy, in normal subjects and hemodialysis patients. Methods: In a randomized, double-blind, ascending-dose study in normal volunteers (n = 41), 6 subjects received placebo, and 8 subjects each received ferumoxytol, at 1, 2 or 4 mg iron/kg, injected at 60 mg iron/min. The remaining subjects received 4 mg iron/kg at injection rates of 90 (n = 3), 180 (n = 3) or 1,800 mg iron/min (n = 5). In the second, open-label, ascending-dose study, 20 hemodialysis patients received 125 or 250 mg of iron over 5 min. Results: In normal subjects, the blood half-life of ferumoxytol increased with increasing dose from 9.3 to 14.5 h (p < 0.05) but not with increasing rate of injection. The drug half-life in hemodialysis patients was similar to normal subjects. Ferumoxytol was not removed with hemodialysis. Serum iron (p < 0.001), transferrin saturation (p < 0.001) and ferritin increased in both populations. No serious adverse events were attributable to ferumoxytol. Conclusion: Ferumoxytol was well tolerated in this study. Its pharmacokinetic properties and simplicity of administration suggest that it will be an attractive form of iron replacement therapy.

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“…Transient hypotension, flushing, urticaria, vomiting and diarrhea are rarely (n = 10) seen adverse reactions. Whether or not it can be dialyzed has not been assessed so far [2, 3, 16]. Chandler et al [17] found that intravenous infusion doses of 200–300 mg given over 2–3 h were safe and well tolerated.…”

Section: Discussionmentioning

confidence: 99%

Treatment of Iron Deficiency Anemia with Intravenous Iron Preparations

Akarsu

Taşkın²,

Yı́lmaz³

et al. 2006

Acta Haematol

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Objective: We aimed to determine the effects of intravenous iron therapy on blood parameters in pediatric patients who do not tolerate oral iron therapy for any reason. Patients and Methods: The patient group consisted of candidates for elective operations requiring blood transfusions in order to raise hemoglobin (Hb) concentrations rapidly and for whom oral iron administration is useless and compliance with long-term treatment is definitely impossible due to sociocultural factors. Sixty-two children were included in the study. Venous blood samples were taken at diagnosis, and after 1 week and 1, 2 and 3 months. Hb, hematocrit, erythrocyte indices (mean erythrocyte volume, mean erythrocyte Hb and mean erythrocyte Hb concentration), serum iron (SI) levels, iron binding capacity, transferrin receptor (CD71) and serum ferritin levels were measured. Iron sucrose was used as an intravenous iron preparation. Results: All children showed improvements in iron deficiency anemia. A statistically significant elevation occurred between the time of diagnosis and week 1 (p<0.05) in nearly all parameters. SI was raised until at least 1 month of therapy. There was no significant difference between transferrin receptors measured before and after the intravenous iron therapy. Ferritin did not exceed the values achieved in the 1st month. Mild side effects were encountered in only 8 (12.9%) patients. Treatment was not discontinued because of side effects in any case. The patients in the control group were given an oral form containing ferroglycine sulfate. Conclusion: Intravenous iron therapy can replace oral therapy in patients whose blood parameters must be raised rapidly and in situations where oral iron administration would not be appropriate for any reason. However, reinforcement with oral iron therapy or additional intravenous doses would be appropriate.

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Randomized cross-over study of adverse reactions and cost implications of intravenous push compared with infusion of iron dextran in hemodialysis patients

Cited by 35 publications

References 3 publications

Ferumoxytol for Treating Iron Deficiency Anemia in CKD

Ferumoxytol for Treating Iron Deficiency Anemia in CKD

Pharmacokinetic Study of Ferumoxytol: A New Iron Replacement Therapy in Normal Subjects and Hemodialysis Patients

Treatment of Iron Deficiency Anemia with Intravenous Iron Preparations

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