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Intravenous iron preparations have shown benefit in patients with chronic heart failure (CHF) and iron deficiency. Iron isomaltoside 1000 (Monofer) is a novel intravenous iron compound with low immunological activity of the isomaltoside and low free-iron-related toxicity. The primary objective of this open-label, non-comparative, multicenter pilot study was to test the safety of iron isomaltoside 1000 in patients with CHF and anemia. In addition, its effect on markers of iron deficiency, anemia and on quality of life was assessed. Twenty patients with CHF and iron deficiency anemia attended six visits during the 8-week study period. Iron isomaltoside 1000 was infused at baseline (mean dose 868 mg, range 650-1000 mg). No treatment-related adverse reactions, no acute anaphylactic or delayed allergic reactions and no clinically significant changes in routine clinical laboratory safety tests or vital signs were observed. Markers of iron deficiency, anemia and quality of life improved from baseline with increase in mean value of 49% at 4 weeks in overall quality of life. Iron isomaltoside 1000 administered as a fast single infusion without a test dose to patients with CHF improved quality-of-life assessments and was well tolerated in this pilot safety study. [ABSTRACT FROM AUTHOR]

Chronic iron deficiency is a common cause of symptomatic anemia, but despite this it is often overlooked or not optimally managed. Frequently, this is because the diagnosis is not confirmed and the response to treatment may be inadequate because of poor compliance, malabsorbtion or recurrent blood loss. Oral iron is blamed for many treatment-limiting gastrointestinal symptoms, and if patients are admitted to hospital with symptoms they are frequently transfused. Intravenous iron can be used to deliver a predictable dose of iron over a short time with many safety, time and economic advantages compared with blood transfusion. Unlike blood transfusion, it is easy to replace physiological storage iron or even to anticipate future blood loss. Preparations of intravenous iron are available which enable even severely anemic patients to be fully treated in two hospital visits. The speed of response to intravenous iron is fast, with rises in hemoglobin levels exceeding 2 g/dL per week in severely iron-deficient subjects. In patients with recurrent blood loss and a satisfactory response, multiple ongoing treatments with intravenous iron are feasible. [ABSTRACT FROM AUTHOR]

Recently there has been an enormous tumult over the use of the erythropoiesis-stimulating agents (ESAs) epoetin alfa and beta and darbepoetin alfa. Recommendations ranging from stopping their use in certain tumor types to withholding therapy until hemoglobin levels reach 9 g/dL or less have been proposed. These recommendations result from inconclusive and imbalanced trials favoring the placebo groups but which nonetheless raise significant concerns about the potential of ESAs to upregulate erythropoietin receptors on tumor cells. Therefore, there has never been a greater need to ensure that appropriate administration of intravenous iron is given with ESAs. In several published and soon-to-be-published trials comparing adjuvant therapy with intravenous and oral iron, without exception intravenous iron improved hemoglobin and hematopoietic responses, shortened times to maximal response, decreased exposure to ESAs and provided huge cost savings. Furthermore, these benefits were independent of patients’ pretreatment iron parameters, such as serum ferritin, transferrin saturation and the presence or absence of bone marrow hemosiderin. Nonetheless, resistance to intravenous iron usage in oncology abounds. This resistance is due to misinformation and misinterpretation of the incidence and clinical nature of serious adverse events. Now that there are three safe intravenous iron preparations, a new paradigm incorporating intravenous iron to ESA therapy in oncology needs to be examined. [ABSTRACT FROM AUTHOR]

We prospectively investigated the utility of preoperative intravenous (IV) iron treatment to increase hemoglobin (Hb) levels and reduce the need for transfusion in women with iron deficiency anemia (IDA) or iron deficiency (ID) scheduled for elective abdominal hysterectomy. Seventy-five women with ID or IDA were enrolled in the study. Women having their surgical procedure at least 1 month after preoperative assessment received IV iron sucrose during 2–4 weeks (IV iron group, n = 31). Women having their surgical procedure a few days after preoperative assessment did not receive IV iron (control group, n = 44). At baseline, there were no differences between the two groups in terms of weight or age, prevalence of anemia, Hb levels or iron laboratory parameters. IV iron sucrose (760 ± 290 mg) increased preoperative Hb (ΔHb: 2.2 ± 1.2 g/dL; P < 0.001) and reduced postoperative transfusion rates when compared with the control group (32% vs. 0%, respectively; P < 0.001). In addition, fewer women from the IV iron group were anemic on postoperative day 21 (23% vs. 68%, respectively; P < 0.01). No life-threatening iron sucrose adverse effect was observed. Because of the rapid increase in Hb levels, IV iron sucrose administration seems to be an effective approach for treating preoperative anemia and reducing transfusion rates in this female population. [ABSTRACT FROM AUTHOR]

Intravenous iron administration is an effective method of treating iron deficiency anemia, but there have been concerns about adverse side effects, particularly serious events such as anaphylactic reaction. Several different forms of intravenous iron are available, but few studies have attempted to compare the frequency of adverse events. We carried out a systematic review to assess the frequency of adverse drug events (ADEs) associated with (i) low-molecular-weight intravenous iron dextran and (ii) iron sucrose. We searched several electronic databases; two reviewers screened all studies identified and extracted data. We included 60 studies, but few directly compared adverse events associated with two or more forms of iron, and most were not specifically designed to evaluate adverse events. In general, with the exception of high-molecular-weight iron dextran (HMWID), serious or life-threatening adverse events appeared rare. Several studies showed lower risks of ADEs on low-molecular-weight iron dextran (LMWID) compared with HMWID, and one large review found a reduced risk on LMWID compared with iron gluconate. Two studies showed little difference between iron sucrose and iron gluconate, and two further studies had similar rates of adverse drug events between iron sucrose and LMWID; however, the sample size for most of these studies was too small to draw firm conclusions. Adequately powered direct comparisons of different forms of intravenous iron are required to assess the safety profiles. [ABSTRACT FROM AUTHOR]