University of Hertfordshire

Intravenous Iron in Patients Undergoing Maintenance Hemodialysis

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Intravenous Iron in Patients Undergoing Maintenance Hemodialysis. / Macdougall, Iain C; White, Claire; Anker, Stefan; Bhandari, Sunil; Farrington, Kenneth; Kalra, Philip; McMurray, John; Murray, Heather; Tomson, Charles; Wheeler, David ; Winearls, Christopher ; Ford, Ian.

In: New England Journal of Medicine, 26.10.2018.

Research output: Contribution to journalArticle

Harvard

Macdougall, IC, White, C, Anker, S, Bhandari, S, Farrington, K, Kalra, P, McMurray, J, Murray, H, Tomson, C, Wheeler, D, Winearls, C & Ford, I 2018, 'Intravenous Iron in Patients Undergoing Maintenance Hemodialysis', New England Journal of Medicine. https://doi.org/10.1056/NEJMoa1810742

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Author

Macdougall, Iain C ; White, Claire ; Anker, Stefan ; Bhandari, Sunil ; Farrington, Kenneth ; Kalra, Philip ; McMurray, John ; Murray, Heather ; Tomson, Charles ; Wheeler, David ; Winearls, Christopher ; Ford, Ian. / Intravenous Iron in Patients Undergoing Maintenance Hemodialysis. In: New England Journal of Medicine. 2018.

Bibtex

@article{f6df1a6bc72e4bf79e67958de74668d8,
title = "Intravenous Iron in Patients Undergoing Maintenance Hemodialysis",
abstract = "BACKGROUND: Intravenous iron is a standard treatment for patients undergoing hemodialysis, but comparative data regarding clinically effective regimens are limited. METHODS: In a multicenter, open-label trial with blinded end-point evaluation, we randomly assigned adults undergoing maintenance hemodialysis to receive either high-dose iron sucrose, administered intravenously in a proactive fashion (400 mg monthly, unless the ferritin concentration was >700 μg per liter or the transferrin saturation was ≥40{\%}), or low-dose iron sucrose, administered intravenously in a reactive fashion (0 to 400 mg monthly, with a ferritin concentration of <200 μg per liter or a transferrin saturation of <20{\%} being a trigger for iron administration). The primary end point was the composite of nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, or death, assessed in a time-to-first-event analysis. These end points were also analyzed as recurrent events. Other secondary end points included death, infection rate, and dose of an erythropoiesis-stimulating agent. Noninferiority of the high-dose group to the low-dose group would be established if the upper boundary of the 95{\%} confidence interval for the hazard ratio for the primary end point did not cross 1.25. RESULTS: A total of 2141 patients underwent randomization (1093 patients to the high-dose group and 1048 to the low-dose group). The median follow-up was 2.1 years. Patients in the high-dose group received a median monthly iron dose of 264 mg (interquartile range [25th to 75th percentile], 200 to 336), as compared with 145 mg (interquartile range, 100 to 190) in the low-dose group. The median monthly dose of an erythropoiesis-stimulating agent was 29,757 IU in the high-dose group and 38,805 IU in the low-dose group (median difference, -7539 IU; 95{\%} confidence interval [CI], -9485 to -5582). A total of 333 patients (30.5{\%}) in the high-dose group had a primary end-point event, as compared with 343 (32.7{\%}) in the low-dose group (hazard ratio, 0.88; 95{\%} CI, 0.76 to 1.03; P<0.001 for noninferiority). In an analysis that used a recurrent-events approach, there were 456 events in the high-dose group and 538 in the low-dose group (rate ratio, 0.78; 95{\%} CI, 0.66 to 0.92). The infection rate was the same in the two groups. CONCLUSIONS: Among patients undergoing hemodialysis, a high-dose intravenous iron regimen administered proactively was noninferior to a low-dose regimen administered reactively and resulted in lower doses of erythropoiesis-stimulating agent being administered",
author = "Macdougall, {Iain C} and Claire White and Stefan Anker and Sunil Bhandari and Kenneth Farrington and Philip Kalra and John McMurray and Heather Murray and Charles Tomson and David Wheeler and Christopher Winearls and Ian Ford",
note = "{\circledC} 2018 Massachusetts Medical Society. All rights reserved.",
year = "2018",
month = "10",
day = "26",
doi = "10.1056/NEJMoa1810742",
language = "English",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",

}

RIS

TY - JOUR

T1 - Intravenous Iron in Patients Undergoing Maintenance Hemodialysis

AU - Macdougall, Iain C

AU - White, Claire

AU - Anker, Stefan

AU - Bhandari, Sunil

AU - Farrington, Kenneth

AU - Kalra, Philip

AU - McMurray, John

AU - Murray, Heather

AU - Tomson, Charles

AU - Wheeler, David

AU - Winearls, Christopher

AU - Ford, Ian

N1 - © 2018 Massachusetts Medical Society. All rights reserved.

PY - 2018/10/26

Y1 - 2018/10/26

N2 - BACKGROUND: Intravenous iron is a standard treatment for patients undergoing hemodialysis, but comparative data regarding clinically effective regimens are limited. METHODS: In a multicenter, open-label trial with blinded end-point evaluation, we randomly assigned adults undergoing maintenance hemodialysis to receive either high-dose iron sucrose, administered intravenously in a proactive fashion (400 mg monthly, unless the ferritin concentration was >700 μg per liter or the transferrin saturation was ≥40%), or low-dose iron sucrose, administered intravenously in a reactive fashion (0 to 400 mg monthly, with a ferritin concentration of <200 μg per liter or a transferrin saturation of <20% being a trigger for iron administration). The primary end point was the composite of nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, or death, assessed in a time-to-first-event analysis. These end points were also analyzed as recurrent events. Other secondary end points included death, infection rate, and dose of an erythropoiesis-stimulating agent. Noninferiority of the high-dose group to the low-dose group would be established if the upper boundary of the 95% confidence interval for the hazard ratio for the primary end point did not cross 1.25. RESULTS: A total of 2141 patients underwent randomization (1093 patients to the high-dose group and 1048 to the low-dose group). The median follow-up was 2.1 years. Patients in the high-dose group received a median monthly iron dose of 264 mg (interquartile range [25th to 75th percentile], 200 to 336), as compared with 145 mg (interquartile range, 100 to 190) in the low-dose group. The median monthly dose of an erythropoiesis-stimulating agent was 29,757 IU in the high-dose group and 38,805 IU in the low-dose group (median difference, -7539 IU; 95% confidence interval [CI], -9485 to -5582). A total of 333 patients (30.5%) in the high-dose group had a primary end-point event, as compared with 343 (32.7%) in the low-dose group (hazard ratio, 0.88; 95% CI, 0.76 to 1.03; P<0.001 for noninferiority). In an analysis that used a recurrent-events approach, there were 456 events in the high-dose group and 538 in the low-dose group (rate ratio, 0.78; 95% CI, 0.66 to 0.92). The infection rate was the same in the two groups. CONCLUSIONS: Among patients undergoing hemodialysis, a high-dose intravenous iron regimen administered proactively was noninferior to a low-dose regimen administered reactively and resulted in lower doses of erythropoiesis-stimulating agent being administered

AB - BACKGROUND: Intravenous iron is a standard treatment for patients undergoing hemodialysis, but comparative data regarding clinically effective regimens are limited. METHODS: In a multicenter, open-label trial with blinded end-point evaluation, we randomly assigned adults undergoing maintenance hemodialysis to receive either high-dose iron sucrose, administered intravenously in a proactive fashion (400 mg monthly, unless the ferritin concentration was >700 μg per liter or the transferrin saturation was ≥40%), or low-dose iron sucrose, administered intravenously in a reactive fashion (0 to 400 mg monthly, with a ferritin concentration of <200 μg per liter or a transferrin saturation of <20% being a trigger for iron administration). The primary end point was the composite of nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, or death, assessed in a time-to-first-event analysis. These end points were also analyzed as recurrent events. Other secondary end points included death, infection rate, and dose of an erythropoiesis-stimulating agent. Noninferiority of the high-dose group to the low-dose group would be established if the upper boundary of the 95% confidence interval for the hazard ratio for the primary end point did not cross 1.25. RESULTS: A total of 2141 patients underwent randomization (1093 patients to the high-dose group and 1048 to the low-dose group). The median follow-up was 2.1 years. Patients in the high-dose group received a median monthly iron dose of 264 mg (interquartile range [25th to 75th percentile], 200 to 336), as compared with 145 mg (interquartile range, 100 to 190) in the low-dose group. The median monthly dose of an erythropoiesis-stimulating agent was 29,757 IU in the high-dose group and 38,805 IU in the low-dose group (median difference, -7539 IU; 95% confidence interval [CI], -9485 to -5582). A total of 333 patients (30.5%) in the high-dose group had a primary end-point event, as compared with 343 (32.7%) in the low-dose group (hazard ratio, 0.88; 95% CI, 0.76 to 1.03; P<0.001 for noninferiority). In an analysis that used a recurrent-events approach, there were 456 events in the high-dose group and 538 in the low-dose group (rate ratio, 0.78; 95% CI, 0.66 to 0.92). The infection rate was the same in the two groups. CONCLUSIONS: Among patients undergoing hemodialysis, a high-dose intravenous iron regimen administered proactively was noninferior to a low-dose regimen administered reactively and resulted in lower doses of erythropoiesis-stimulating agent being administered

U2 - 10.1056/NEJMoa1810742

DO - 10.1056/NEJMoa1810742

M3 - Article

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

ER -