scholarly journals A Phase III, randomized, open‐label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy

2014 ◽  
Vol 89 (6) ◽  
pp. 646-650 ◽  
Author(s):  
David Hetzel ◽  
William Strauss ◽  
Kristine Bernard ◽  
Zhu Li ◽  
Audrone Urboniene ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Iron Sucrose ◽  
Phase Iii ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Open Label ◽  
Oral Iron Therapy ◽  
History Of ◽  
Open Label Trial

Ferumoxytol Treatment Results in Robust Hemoglobin Increases in Iron Deficiency Anemia Patients with a History of Unsatisfactory Oral Iron Therapy in a Phase III, Randomized, Placebo-Controlled Trial.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2098-2098
Author(s):  
Saroj Vadhan Raj ◽  
Michael Cressman ◽  
David Ford ◽  
William Strauss ◽  
Gerri Poss ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Group Treatment ◽  
Oral Iron ◽  
Phase Iii ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Oral Iron Therapy ◽  
History Of ◽  
Iv Iron

Abstract Abstract 2098 Background: Although oral iron therapy is often the initial approach to the treatment of iron deficiency anemia (IDA), many patients fail to adequately respond or do not tolerate oral iron. Unfortunately for these patients, approved treatment options are limited in the US and Canada to only the IV iron dextrans, which have boxed safety warnings and inconvenient dosing regimens. Many of these patients, therefore, do not get IV iron, and remain inadequately treated and symptomatic. Ferumoxytol (FER), a new IV iron approved for the treatment of IDA in patients with chronic kidney disease (CKD), is being investigated to treat IDA patients without CKD who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used. This randomized, placebo-controlled, double blind trial was designed to assess the efficacy and safety of FER for the treatment of these IDA patients. Methods: Key inclusion criteria included a Baseline hemoglobin (Hgb) less than 10 g/dL and >7 g/dL, and transferrin saturation (TSAT) <20%. Subjects were randomized 3:1 to receive 2 injections of either FER (510 mg, 5±3 days apart) or placebo (IV normal saline). Efficacy assessments included comparisons of the change in Hgb, TSAT and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score in the 2 treatment groups between Baseline and Week 5. Results: A total of 808 subjects were randomized to the 2 treatment arms (FER, n=608; placebo, n=200). FER demonstrated superiority to placebo with 81.1% of subjects achieving an increase in Hgb of >2.0 g/dL from Baseline to Week 5 compared to only 5.5% in the placebo group (treatment difference: 75.6%, p<0.0001). At each post-FER treatment time point, a larger percentage of FER-treated subjects had a >2.0 g/dL increase in Hgb compared with those treated with placebo. The superiority of FER was also demonstrated for the mean change in Hgb from Baseline to Week 5 with a robust 2.7 g/dL increase compared to only 0.1 g/dL in the placebo group (treatment difference: 2.54 g/dL, p<0.0001). An increase in TSAT from Baseline to Week 5 was only observed in FER-treated subjects (mean change: FER, 11.0%; placebo −0.1%). In addition, a statistically significant improvement in fatigue from Baseline to Week 5, as measured by the FACIT-Fatigue, was shown for FER-treated subjects compared to placebo (p<0.0001). The rates of adverse events (AEs) and related AEs were higher in the FER group, although no pattern or safety trend was observed to suggest a specific safety signal. The overall rate of serious adverse events (SAEs) was comparable between the 2 treatment groups (FER, 2.6%; placebo, 3.0%), and treatment-related SAEs associated with the class of IV iron products were reported in 4 (0.7%) FER-treated subjects. As expected, protocol-defined AEs of Special Interest (signs/symptoms of hypotension or hypersensitivity associated with IV iron use) were noted at a higher rate in FER-treated subjects (FER, 3.6%; placebo, 1.0%). All cardiovascular AEs were considered unrelated by the investigators. Overall, FER was well tolerated and no new safety signals were identified. Conclusion: In this randomized, placebo-controlled Phase III trial, 2 doses of FER were shown to be highly effective in raising hemoglobin and iron parameters in non-CKD patients with IDA who had a history of unsatisfactory oral iron therapy. FER also significantly reduced fatigue, and was generally well tolerated with no new safety signals being identified. Therefore, FER could provide an important, new treatment option for IDA patients with a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. Disclosures: Vadhan Raj: AMAG Pharmaceuticals, Inc.: Research Funding. Off Label Use: Feraheme (ferumoxytol) injection. For treatment of iron deficiency anemia in non-CKD patients. Cressman:AMAG Pharmaceuticals, Inc.: Employment. Strauss:AMAG Pharmaceuticals, Inc.: Employment. Bernard:AMAG Pharmaceuticals, Inc.: Employment. Li:AMAG Pharmaceuticals, Inc.: Employment. Allen:AMAG Pharmaceuticals, Inc.: Employment.

scholarly journals Efficacy and safety of high dose accelerated intravenous iron sucrose in patients of iron deficiency anemia

2017 ◽  
Vol 5 (8) ◽  
pp. 3359
Author(s):  
Muzafar Naik ◽  
Tariq Bhat ◽  
Ummer Jalalie ◽  
Arif Bhat ◽  
Mir Waseem ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Intravenous Iron ◽  
Oral Iron ◽  
Iron Sucrose ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
High Dose ◽  
Oral Iron Therapy ◽  
The Mean

Background: Low dose (200 mg) extended Intravenous iron sucrose remains the most common treatment option in patients who are intolerant to oral iron therapy in patients with Iron deficiency anemia (IDA). The objective of this study was to evaluate the efficacy and safety of high dose accelerated intravenous iron sucrose (IS) in the treatment of adults with iron deficiency anemiaMethods: One hundred adult patients with iron deficiency anemia, who had intolerance or showed no effect with oral iron therapy, received daily doses of 500 mg of intravenous iron sucrose until the hemoglobin level was corrected or until receiving the total dose of intravenous iron calculated for each patient.Results: The mean and median Hb (g/dL) 6.47±1.656 and 6.6 (2) at baseline, 9.61±1.629 and 9.6 (2) at 2 weeks of treatment, 11.85±1.277 and 12 (1) at 4 weeks of treatment respectively. The mean rise of Hb was 3.13±1.41 and 5.37±1.50 after 2 and 4 weeks of treatment respectively (p<0.000). A total of 303 intravenous infusions of iron sucrose were administered and iron sucrose was generally well tolerated with twenty-six patients developing mild and one patient developing moderate adverse drug reactions. There was no serious adverse event recorded.Conclusions: Accelerated high dose intravenous iron sucrose is a safe and cost effective option minimizing frequent hospital visits in the treatment of adults with iron deficiency anemia who are intolerant or lack satisfactory response to oral iron therapy.

Potential New Treatment Option for Iron Deficiency Anemia Patients with a History of Unsatisfactory Oral Iron Therapy- Results of a Phase III, Randomized, Open-Label, Active-Controlled Trial of Ferumoxytol.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2099-2099 ◽  
Author(s):  
David Hetzel ◽  
Audrone Urboniene ◽  
Kristine Bernard ◽  
William Strauss ◽  
Michael Cressman ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Controlled Trial ◽  
Treatment Options ◽  
Oral Iron ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Oral Iron Therapy ◽  
History Of ◽  
Iv Iron

Abstract Abstract 2099 Background: While oral iron is the preferred first-line treatment for patients with iron deficiency anemia (IDA), there are patients who cannot take oral iron, do not tolerate it or do not adequately respond to oral iron. In the US and Canada, the only approved treatment options for these patients are the iron dextrans, which have boxed safety warnings and inconvenient dosing regimens. Therefore, many of these anemic patients do not receive IV iron, and remain inadequately treated and symptomatic. In the EU, several IV irons, including iron sucrose (IS), are approved for second line use. Few studies have evaluated the IV irons in head-to-head studies. Ferumoxytol (FER) is a new IV iron approved for the treatment of IDA in patients with chronic kidney disease (CKD) that is formulated to allow for bolus IV injection. This randomized, controlled trial was designed to investigate the efficacy and safety of FER compared to IS for the treatment of IDA in patients with a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. Methods: The study was designed to demonstrate non-inferiority and consisted of a 14 day screening period, treatment and a 5 week follow-up period. Key inclusion criteria included a Baseline hemoglobin (Hgb) less than 10 g/dL and >7 g/dL, and transferrin saturation (TSAT) < 20%. Patients were randomized 2:1 to receive either FER, administered as 2 injections of 510 mg 5±3 days apart, or IS, administered as 5 infusions or injections of 200 mg on 5 non-consecutive days over a 14 day period. Results: A total of 605 subjects were randomized to the 2 treatment arms (FER, n= 406; IS, n=199). FER demonstrated non-inferiority to IS in the proportion of subjects with a >2.0 g/dL increase in Hgb at any time from Baseline to Week 5 (the primary efficacy endpoint), compared to those treated with IS, (FER, 84%; IS 81%) with the lower bound of the 95% CI [-3.89%] above the predefined non inferiority margin [-15%]. In addition at each post-treatment time point, a higher percentage of FER-treated subjects achieved a >2.0 g/dL increase in Hgb compared to those treated with IS. FER also achieved non-inferiority to IS in the mean change in Hgb from Baseline to Week 5 with a robust 2.7g/dL increase in Hgb compared to 2.4g/dL with IS (the lower bound of the 95% CI [0.06g/dL] was above the predefined non-inferiority margin [-0.5g/dL]); this treatment difference (0.3 g/dL) was statistically significant (p=0.0124), and FER actually achieved superiority over IS. The overall rates of adverse events (AEs) and related AEs were lower in the FER group compared to IS-treated subjects. The serious adverse event (SAE) rate was higher in FER-treated subjects (FER, 4.2%; IS, 2.5%), but no pattern or safety trend was observed to suggest a specific safety signal; treatment-related SAEs were reported in 2 (0.5%) FER-treated subjects (1 anaphylactoid reaction and 1 hypertension). Protocol-defined AEs of Special Interest (signs/symptoms of hypotension or hypersensitivity associated with IV iron use) were reported at a higher rate in IS-treated subjects compared to the FER treatment group (IS, 5.0%; FER, 2.7%). Cardiovascular AE rates were comparable in the 2 treatment groups (1.0%). Overall, the safety profile of FER was comparable to that of IS and no new safety signals were identified. Conclusion: In this randomized, controlled trial, the efficacy and safety of 2 doses of FER were shown to be comparable to IS in treating IDA patients with a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. For this IDA patient population, which has limited treatment options in the US and Canada, FER may offer an important, new treatment option with a convenient 2 dose regimen. Disclosures: Off Label Use: Feraheme (ferumoxytol) injection. For treatment of iron deficiency anemia in non-CKD patients. Bernard:AMAG Pharmaceuticals, Inc.: Employment. Strauss:AMAG Pharmaceuticals, Inc.: Employment. Cressman:AMAG Pharmaceuticals, Inc.: Employment. Li:AMAG Pharmaceuticals, Inc.: Employment. Allen:AMAG Pharmaceuticals, Inc.: Employment.

Ferumoxytol Treatment Demonstrates Significant Improvements in Fatigue and Health-Related Quality of Life in Iron Deficiency Anemia Patients with a History of Unsatisfactory Oral Iron Therapy

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 478-478
Author(s):  
Saroj Vadhan Raj ◽  
Andrew Hsieh ◽  
William Strauss ◽  
Michael Stevenson ◽  
Kristine Bernard ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Oral Iron ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Oral Iron Therapy ◽  
Sf 36 ◽  
Related Quality ◽  
History Of ◽  
Time Point

Abstract Abstract 478 Introduction: Iron is essential for the function of many key proteins including hemoglobin (Hgb) and myoglobin (involved in oxygen transport/exchange), cytochromes (involved in energy generation), various enzymes (involved in cell proliferation and neurotransmission), and immune function. Iron deficiency can, therefore, negatively impact patients' health-related quality of life (HRQL) and requires treatment to replete iron stores. Although oral iron is a common initial treatment, some patients do not tolerate it or fail to adequately respond; many of these patients, therefore, live with chronic anemia and the related negative effects on their overall HRQL. Ferumoxytol (FER) is a new IV iron indicated for the treatment of Iron Deficiency Anemia (IDA) in patients with chronic kidney disease (CKD). FER is being investigated to treat IDA patients without CKD who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used. To prospectively explore the impact of FER treatment on patient reported outcomes (PROs), the Phase 3 clinical trials included: the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue); the Short Form Health Survey (SF-36); and the Linear Analogue Scale Assessment (LASA) of Energy, Activities of Daily Living (ADL) and HRQL. Methods: IDA patients with Hgb <10.0 g/dL and >7 g/dL, and transferrin saturation (TSAT) <20% were eligible. Eight hundred-eight subjects were randomized 3:1 to receive either 2 injections of 510 mg of FER administered 5±3 days apart or IV normal saline (placebo). FACIT-Fatigue assessments were done pre-dose at Baseline and weekly up to Week 5; the SF-36 and LASA were administered at Baseline, Week 3 and Week 5. Comparison of the mean change in FACIT-Fatigue scores from Baseline to Week 5 was a pre-specified secondary endpoint; mean change in the SF-36 Vitality Domain and LASA scores were exploratory endpoints. Results: At Baseline, FACIT-Fatigue scores for both treatment groups were lower (FER, 24.0 ±11.8; placebo, 24.7 ±11.3) than general (non-anemic) US population norms (40.1), and comparable to anemic cancer patients receiving chemotherapy (23.9). FER-treated subjects showed a robust 2.7 g/dL increase in mean Hgb from Baseline to Week 5, compared to only a 0.1 g/dL increase with placebo (p<0.0001). Paralleling this Hgb increase, FER-treated subjects also demonstrated large improvements in FACIT-Fatigue scores at each time point with significant improvement as early as Week 1 (+7 point change). Further improvements in fatigue were seen at weeks 2, 3, and 4 after FER treatment, and by Week 5, FACIT-Fatigues scores had increased over 12 points (36.8±11.2) and approached general population norms (40.1). In contrast, FACIT-Fatigue scores in placebo-treated subjects showed a lower increase at Week 1 and no further increase at subsequent time points. At all post-treatment time points, the FACIT-Fatigue score increases in FER-treated subjects were statistically significantly higher than placebo-treated subjects. FER-treated subjects demonstrated significantly greater improvements in SF-36 Vitality scores at each time point following FER treatment relative to placebo. In addition, significantly greater improvements in LASA Energy, ADL and HRQL scores were observed at each time point compared to placebo; these improvements continued to increase for FER at Week 5, but decreased for placebo. Mean Change in FACIT-Fatigue Scores Conclusions: These data suggest that FER may provide important clinical benefits to IDA patients with a history of unsatisfactory oral iron therapy; these benefits include reductions in fatigue, increased energy, vitality, and ability to perform ADL and improved HRQL. This is important especially in light of the poor baseline energy and HRQL scores of patients who cannot take oral iron. FER could, therefore, provide an important, new treatment option for IDA patients with a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used. Disclosures: Vadhan Raj: AMAG Pharmaceuticals, Inc.: Research Funding. Off Label Use: Feraheme (ferumoxytol) injection. For treatment of iron deficiency anemia in non-CKD patients. Hsieh:AMAG Pharmaceuticals, Inc.: Employment. Strauss:AMAG Pharmaceuticals, Inc.: Employment. Stevenson:AMAG Pharmaceuticals, Inc.: Employment. Bernard:AMAG Pharmaceuticals, Inc.: Employment. Allen:AMAG Pharmaceuticals, Inc.: Employment.

scholarly journals Efficacy and safety of intravenous iron sucrose treatment in children with iron deficiency anemia

2019 ◽  
Vol 6 (10) ◽  
pp. 278-283
Author(s):  
Elif Güler Kazancı ◽  
Muhammet Furkan Korkmaz ◽  
Betül Orhaner
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Intravenous Iron ◽  
Iron Sucrose ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Efficacy And Safety ◽  
Oral Iron Therapy ◽  
Parenteral Iron ◽  
Parenteral Iron Therapy

Objective:  The purpose of this study is to investigate the efficacy and safety of intravenous iron sucrose treatment in children with iron deficiency anemia who were unresponsive to or could not tolerate oral iron therapy. Material and Methods: Among patients determined to have iron deficiency anemia, and were intolerant or noncompliant with oral iron therapy, 92 patients who have received parenteral iron therapy between the ages of 6 months and 18 years have been investigated retrospectively. Age, gender, patient complaints at application,  dietary characteristics, accompanying diseases and treatment complications, and safety, tolerability, and adverse events have been assessed from the information obtained from patient files. Treatment efficiency was evaluated with hemoglobin (Hb), mean corpuscular volume (MCV) and ferritin results from the blood samples taken before treatment, at the second week of treatment and after two months. Results: Mean age of patients was 12.5 ± 4.7 (age interval 1-17 years), and 21% was male while 79% was female. 72% of our patients were adolescents. From an etiological aspect, 56% of our patients was determined to have an iron-poor diet, 29% had functional menorrhagia, and 15% had chronic gastrointestinal system pathologies. Mean Hb, MCV and ferritin levels before and after treatment were found as: 7.72 ± 1.21 g/dl and 11.44 g/dl ± 0.68 g/dl;  63.2 ± 7.12  fL and  76.6 ± 3.81  fL; 3.87 ± 2.52 nmol/L and 57.94 ± 17.19  nmol/L, respectively (p< 0.001). 94% of patients were determined to have at least 2 g/dL (mean value 3.71 [range 1.6-6.3]) increase in their Hb levels. Anaphylaxis was observed in a patient who had a history of allergy despite applying premedication. Conclusion: Parenteral iron therapy is an efficient and safe treatment among indicated patients.

scholarly journals IRON ABSORPTION AND RESPONSE TO ORAL IRON THERAPY IN IRON DEFICIENCY ANEMIA ASSOCIATED TO ASYMPTOMATIC GIARDIASIS.

1993 ◽  
Vol 33 (6) ◽  
pp. 661-661
Author(s):  
Helena U Suzuki ◽  
Mauro B Morais ◽  
Jose N Corral ◽  
Ulisses Fagundes-Neto ◽  
Nelson L Machado
Keyword(s):  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Iron Absorption ◽  
Oral Iron ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Oral Iron Therapy

scholarly journals Comparative Study of the Effects of Lactoferrin versus Oral Iron Therapy in Obese Children and Adolescents with Iron Deficiency Anemia

2021 ◽  
pp. 104-114
Author(s):  
Manal Mahmoud Atia ◽  
Rasha Mohamed Gama ◽  
Mohamed Attia Saad ◽  
Mohammed Amr Hamam
Keyword(s):  
Iron Deficiency ◽  
Children And Adolescents ◽  
Iron Deficiency Anemia ◽  
Interleukin 6 ◽  
Oral Iron ◽  
Iron Therapy ◽  
Deficiency Anemia ◽  
Obese Children ◽  
Oral Iron Therapy ◽  
Serum Hepcidin

Greater prevalence of iron deficiency (ID) has been observed in overweight and obese children and adolescents. Hepcidin acts as a key regulator of iron metabolism. Hepcidin synthesis increases in response inflammatory cytokines especially Interleukin-6 (IL-6). Considering that obesity represents a low grade chronic inflammatory state, a high concentration of hepcidin has been found in obese children. Elevated hepcidin level in obese children is associated with diminished response to oral iron therapy. Lactoferrin is an iron-binding multifunctional glycoprotein and has strong capacity to modulate the inflammatory response by its capacity to reduce pro-inflammatory cytokine expression in vivo, including IL-6 and hepcidin. Aim of the Work: To compare the efficacy of lactoferrin versus oral iron therapy in treatment of obese children and adolescents with iron deficiency anemia and the effect of therapy on serum hepcidin and interleukin 6 levels. Methodology: This prospective randomized clinical trial was conducted on 40 obese children and adolescents aged between 6 –18 years suffering from iron deficiency anemia (IDA). They were equally randomized into one of 2 groups. Group A received regular oral lactoferrin in a dose of 100 mg/day. Group B received regular oral iron supplementation (Ferric hydroxide polymaltose) in a dose of 6 mg elemental iron/kg /day.Baseline investigations included complete blood count (CBC), iron profile (Serum ferritin, serum iron, total iron binding capacity (TIBC), transferrin saturation), serum Interleukin 6, and serum hepcidin. Reevaluation of CBC was done monthly while iron status parameters, serum IL-6 and serum hepcidin were reevaluated after 3 months of receiving regular therapy. Results: Significant elevations in hemoglobin, MCV, MCH, Serum ferritin, serum iron and transferrin saturation with lactoferrin therapy compared to oral iron therapy. Significantly Lower TIBC after 3 months of lactoferrin therapy while the decrease in TIBC was insignificant in the iron therapy group.Lower serum hepcidin and IL6 after 3 months of lactoferrin therapy with no significant change in serum hepcidin and IL6 after iron therapy. Conclusion: This study clearly demonstrated the superiority of lactoferrin over iron use as oral in the treatment of iron deficiency anemia in obese children not only for the better response of hematological and iron status parameters and less gastrointestinal side effects but also for its effect on decreasing inflammatory biomarkers as hepcidin and IL6.

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