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Effects of IV iron treatment with ferumoxytol on health-related quality of life of patients with iron deficiency anemia
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Effects of IV iron treatment with ferumoxytol on health-related quality of life of patients with iron deficiency anemia
Background Many patients with iron deficiency anemia (IDA) do not tolerate or adequately respond to oral iron and live with chronic anemia and related negative effects on health-related quality of life (HRQoL). However, data from double-blind, placebo-controlled trials exploring the effect of treatment on HRQoL in patients with IDA are lacking.
Objective To explore the HRQoL of IDA patients who are unresponsive to or intolerant of oral iron, and compare the effects of treatment with intravenous ferumoxytol or placebo in a double-blind randomized controlled trial.
Methods Unpublished HRQoL data using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), the Medical Outcomes Survey Short Form-36 (SF-36), and the Linear Analogue Scale Assessment (LASA) were collected from a previous study (NCT01114139). Between-group differences in change from baseline to the end of the study (week 5), evaluation of clinically meaningful change, and comparisons with population norms were analyzed.
Results Baseline HRQoL scores for ferumoxytol patients (n = 608) and placebo patients (n = 200) were notably below general population norms. Despite a substantial placebo effect, significant and clinically meaningful differences were found in favor of patients receiving ferumoxytol compared with those receiving placebo in FACIT-Fatigue improvement (10.6 vs 5.7; 95% CI for difference 3.1-6.71, P < .0001), all LASA domains: Energy (P < .0001), Activities of Daily Living (P < .001) and QoL (P < .0001) improvement, and all SF-36 domains (P's <.01- <.0001).
Limitations Short-term study, low number of cancer patients included (48 of 808)
Conclusions Patients with IDA who had been unsuccessfully treated with oral iron had poor baseline HRQoL scores. Ferumoxytol treatment resulted in clinically meaningful improvements in HRQoL, significantly greater than placebo, across all domains.
Funding/sponsorship AMAG Pharmaceuticals Inc, maker of the study drug
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Issue
The Journal of Community and Supportive Oncology - 14(8)
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Page Number
342-350
Legacy Keywords
iron deficiency anemia, IDA, quality of life, oral iron
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Background Many patients with iron deficiency anemia (IDA) do not tolerate or adequately respond to oral iron and live with chronic anemia and related negative effects on health-related quality of life (HRQoL). However, data from double-blind, placebo-controlled trials exploring the effect of treatment on HRQoL in patients with IDA are lacking.
Objective To explore the HRQoL of IDA patients who are unresponsive to or intolerant of oral iron, and compare the effects of treatment with intravenous ferumoxytol or placebo in a double-blind randomized controlled trial.
Methods Unpublished HRQoL data using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), the Medical Outcomes Survey Short Form-36 (SF-36), and the Linear Analogue Scale Assessment (LASA) were collected from a previous study (NCT01114139). Between-group differences in change from baseline to the end of the study (week 5), evaluation of clinically meaningful change, and comparisons with population norms were analyzed.
Results Baseline HRQoL scores for ferumoxytol patients (n = 608) and placebo patients (n = 200) were notably below general population norms. Despite a substantial placebo effect, significant and clinically meaningful differences were found in favor of patients receiving ferumoxytol compared with those receiving placebo in FACIT-Fatigue improvement (10.6 vs 5.7; 95% CI for difference 3.1-6.71, P < .0001), all LASA domains: Energy (P < .0001), Activities of Daily Living (P < .001) and QoL (P < .0001) improvement, and all SF-36 domains (P's <.01- <.0001).
Limitations Short-term study, low number of cancer patients included (48 of 808)
Conclusions Patients with IDA who had been unsuccessfully treated with oral iron had poor baseline HRQoL scores. Ferumoxytol treatment resulted in clinically meaningful improvements in HRQoL, significantly greater than placebo, across all domains.
Funding/sponsorship AMAG Pharmaceuticals Inc, maker of the study drug
Click on the PDF icon at the top of this introduction to read the full article.
Background Many patients with iron deficiency anemia (IDA) do not tolerate or adequately respond to oral iron and live with chronic anemia and related negative effects on health-related quality of life (HRQoL). However, data from double-blind, placebo-controlled trials exploring the effect of treatment on HRQoL in patients with IDA are lacking.
Objective To explore the HRQoL of IDA patients who are unresponsive to or intolerant of oral iron, and compare the effects of treatment with intravenous ferumoxytol or placebo in a double-blind randomized controlled trial.
Methods Unpublished HRQoL data using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), the Medical Outcomes Survey Short Form-36 (SF-36), and the Linear Analogue Scale Assessment (LASA) were collected from a previous study (NCT01114139). Between-group differences in change from baseline to the end of the study (week 5), evaluation of clinically meaningful change, and comparisons with population norms were analyzed.
Results Baseline HRQoL scores for ferumoxytol patients (n = 608) and placebo patients (n = 200) were notably below general population norms. Despite a substantial placebo effect, significant and clinically meaningful differences were found in favor of patients receiving ferumoxytol compared with those receiving placebo in FACIT-Fatigue improvement (10.6 vs 5.7; 95% CI for difference 3.1-6.71, P < .0001), all LASA domains: Energy (P < .0001), Activities of Daily Living (P < .001) and QoL (P < .0001) improvement, and all SF-36 domains (P's <.01- <.0001).
Limitations Short-term study, low number of cancer patients included (48 of 808)
Conclusions Patients with IDA who had been unsuccessfully treated with oral iron had poor baseline HRQoL scores. Ferumoxytol treatment resulted in clinically meaningful improvements in HRQoL, significantly greater than placebo, across all domains.
Funding/sponsorship AMAG Pharmaceuticals Inc, maker of the study drug
Click on the PDF icon at the top of this introduction to read the full article.
Issue
The Journal of Community and Supportive Oncology - 14(8)
Issue
The Journal of Community and Supportive Oncology - 14(8)
Page Number
342-350
Page Number
342-350
Topics
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Effects of IV iron treatment with ferumoxytol on health-related quality of life of patients with iron deficiency anemia
Display Headline
Effects of IV iron treatment with ferumoxytol on health-related quality of life of patients with iron deficiency anemia
Legacy Keywords
iron deficiency anemia, IDA, quality of life, oral iron
Legacy Keywords
iron deficiency anemia, IDA, quality of life, oral iron
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JCSO 2016;14(8):342-350
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