Intravenous iron exposure and mortality in patients on hemodialysis

Dana C. Miskulin, Navdeep Tangri, Karen Bandeen-Roche, Jing Zhou, Aidan McDermott, Klemens B. Meyer, Patti L. Ephraim, Wieneke M. Michels, Bernard G. Jaar, Deidra C. Crews, Julia J. Scialla, Stephen M. Sozio, Tariq Shafi, Albert W. Wu, Courtney Cook, L. Ebony Boulware

Research output: Contribution to journalArticle

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Abstract

Background and objectives Clinical trials assessing effects of larger cumulative iron exposure with outcomes are lacking, and observational studies have been limited by assessment of short-term exposure only and/or failure to assess cause-specific mortality. The associations between short- and long-term iron exposure on all-cause and cause-specific mortality were examined. Design, setting, participants, & measurements The study included 14,078 United States patients on dialysis initiating dialysis between 2003 and 2008. Intravenous iron dose accumulations over 1-, 3-, and 6-month rolling windows were related to all-cause, cardiovascular, and infection-related mortality in Cox proportional hazards models that used marginal structural modeling to control for time-dependent confounding. Results Patients in the 1-month model cohort (n=14,078) were followed a median of 19 months, during which there were 27.6% all-cause deaths, 13.5% cardiovascular deaths, and 3% infection-related deaths. A reduced risk of all-cause mortality with receipt of.150–350 (hazard ratio, 0.78; 95% confidence interval, 0.64 to 0.95) or.350 mg (hazard ratio, 0.79; 95% confidence interval, 0.62 to 0.99) intravenous iron compared with.0–150 mg over 1 month was observed. There was no relation of 1-month intravenous iron dose with cardiovascular or infection related mortality and no relation of 3- or 6-month cumulative intravenous iron dose with all-cause or cardiovascular mortality. There was a nonstatistically significant increase in infection-related mortality with receipt of.1050mg intravenous iron in 3 months (hazard ratio, 1.69; 95%confidence interval, 0.87 to 3.28) and.2100mg in 6 months (hazard ratio, 1.59; 95% confidence interval, 0.73 to 3.46). Conclusions Among patients on incident dialysis, receipt of #1050 mg intravenous iron in 3 months or 2100 mg in 6 months was not associated with all-cause, cardiovascular, or infection-related mortality. However, nonstatistically significant findings suggested the possibility of infection-related mortality with receipt of.1050 mg in 3 months or.2100 mg in 6 months. Randomized clinical trials are needed to assess the safety of exposure to greater cumulative intravenous iron doses.

Original languageEnglish (US)
Pages (from-to)1930-1939
Number of pages10
JournalClinical Journal of the American Society of Nephrology
Volume9
Issue number11
DOIs
StatePublished - 2015

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Renal Dialysis
Iron
Mortality
Cardiovascular Infections
Confidence Intervals
Dialysis
Infection
Proportional Hazards Models
Observational Studies
Cause of Death
Randomized Controlled Trials
Outcome Assessment (Health Care)
Clinical Trials
Safety

ASJC Scopus subject areas

  • Nephrology
  • Transplantation
  • Epidemiology
  • Critical Care and Intensive Care Medicine

Cite this

Miskulin, D. C., Tangri, N., Bandeen-Roche, K., Zhou, J., McDermott, A., Meyer, K. B., ... Boulware, L. E. (2015). Intravenous iron exposure and mortality in patients on hemodialysis. Clinical Journal of the American Society of Nephrology, 9(11), 1930-1939. https://doi.org/10.2215/CJN.03370414

Intravenous iron exposure and mortality in patients on hemodialysis. / Miskulin, Dana C.; Tangri, Navdeep; Bandeen-Roche, Karen; Zhou, Jing; McDermott, Aidan; Meyer, Klemens B.; Ephraim, Patti L.; Michels, Wieneke M.; Jaar, Bernard G.; Crews, Deidra C.; Scialla, Julia J.; Sozio, Stephen M.; Shafi, Tariq; Wu, Albert W.; Cook, Courtney; Boulware, L. Ebony.

In: Clinical Journal of the American Society of Nephrology, Vol. 9, No. 11, 2015, p. 1930-1939.

Research output: Contribution to journalArticle

Miskulin, DC, Tangri, N, Bandeen-Roche, K, Zhou, J, McDermott, A, Meyer, KB, Ephraim, PL, Michels, WM, Jaar, BG, Crews, DC, Scialla, JJ, Sozio, SM, Shafi, T, Wu, AW, Cook, C & Boulware, LE 2015, 'Intravenous iron exposure and mortality in patients on hemodialysis', Clinical Journal of the American Society of Nephrology, vol. 9, no. 11, pp. 1930-1939. https://doi.org/10.2215/CJN.03370414
Miskulin, Dana C. ; Tangri, Navdeep ; Bandeen-Roche, Karen ; Zhou, Jing ; McDermott, Aidan ; Meyer, Klemens B. ; Ephraim, Patti L. ; Michels, Wieneke M. ; Jaar, Bernard G. ; Crews, Deidra C. ; Scialla, Julia J. ; Sozio, Stephen M. ; Shafi, Tariq ; Wu, Albert W. ; Cook, Courtney ; Boulware, L. Ebony. / Intravenous iron exposure and mortality in patients on hemodialysis. In: Clinical Journal of the American Society of Nephrology. 2015 ; Vol. 9, No. 11. pp. 1930-1939.
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abstract = "Background and objectives Clinical trials assessing effects of larger cumulative iron exposure with outcomes are lacking, and observational studies have been limited by assessment of short-term exposure only and/or failure to assess cause-specific mortality. The associations between short- and long-term iron exposure on all-cause and cause-specific mortality were examined. Design, setting, participants, & measurements The study included 14,078 United States patients on dialysis initiating dialysis between 2003 and 2008. Intravenous iron dose accumulations over 1-, 3-, and 6-month rolling windows were related to all-cause, cardiovascular, and infection-related mortality in Cox proportional hazards models that used marginal structural modeling to control for time-dependent confounding. Results Patients in the 1-month model cohort (n=14,078) were followed a median of 19 months, during which there were 27.6{\%} all-cause deaths, 13.5{\%} cardiovascular deaths, and 3{\%} infection-related deaths. A reduced risk of all-cause mortality with receipt of.150–350 (hazard ratio, 0.78; 95{\%} confidence interval, 0.64 to 0.95) or.350 mg (hazard ratio, 0.79; 95{\%} confidence interval, 0.62 to 0.99) intravenous iron compared with.0–150 mg over 1 month was observed. There was no relation of 1-month intravenous iron dose with cardiovascular or infection related mortality and no relation of 3- or 6-month cumulative intravenous iron dose with all-cause or cardiovascular mortality. There was a nonstatistically significant increase in infection-related mortality with receipt of.1050mg intravenous iron in 3 months (hazard ratio, 1.69; 95{\%}confidence interval, 0.87 to 3.28) and.2100mg in 6 months (hazard ratio, 1.59; 95{\%} confidence interval, 0.73 to 3.46). Conclusions Among patients on incident dialysis, receipt of #1050 mg intravenous iron in 3 months or 2100 mg in 6 months was not associated with all-cause, cardiovascular, or infection-related mortality. However, nonstatistically significant findings suggested the possibility of infection-related mortality with receipt of.1050 mg in 3 months or.2100 mg in 6 months. Randomized clinical trials are needed to assess the safety of exposure to greater cumulative intravenous iron doses.",
author = "Miskulin, {Dana C.} and Navdeep Tangri and Karen Bandeen-Roche and Jing Zhou and Aidan McDermott and Meyer, {Klemens B.} and Ephraim, {Patti L.} and Michels, {Wieneke M.} and Jaar, {Bernard G.} and Crews, {Deidra C.} and Scialla, {Julia J.} and Sozio, {Stephen M.} and Tariq Shafi and Wu, {Albert W.} and Courtney Cook and Boulware, {L. Ebony}",
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T1 - Intravenous iron exposure and mortality in patients on hemodialysis

AU - Miskulin, Dana C.

AU - Tangri, Navdeep

AU - Bandeen-Roche, Karen

AU - Zhou, Jing

AU - McDermott, Aidan

AU - Meyer, Klemens B.

AU - Ephraim, Patti L.

AU - Michels, Wieneke M.

AU - Jaar, Bernard G.

AU - Crews, Deidra C.

AU - Scialla, Julia J.

AU - Sozio, Stephen M.

AU - Shafi, Tariq

AU - Wu, Albert W.

AU - Cook, Courtney

AU - Boulware, L. Ebony

PY - 2015

Y1 - 2015

N2 - Background and objectives Clinical trials assessing effects of larger cumulative iron exposure with outcomes are lacking, and observational studies have been limited by assessment of short-term exposure only and/or failure to assess cause-specific mortality. The associations between short- and long-term iron exposure on all-cause and cause-specific mortality were examined. Design, setting, participants, & measurements The study included 14,078 United States patients on dialysis initiating dialysis between 2003 and 2008. Intravenous iron dose accumulations over 1-, 3-, and 6-month rolling windows were related to all-cause, cardiovascular, and infection-related mortality in Cox proportional hazards models that used marginal structural modeling to control for time-dependent confounding. Results Patients in the 1-month model cohort (n=14,078) were followed a median of 19 months, during which there were 27.6% all-cause deaths, 13.5% cardiovascular deaths, and 3% infection-related deaths. A reduced risk of all-cause mortality with receipt of.150–350 (hazard ratio, 0.78; 95% confidence interval, 0.64 to 0.95) or.350 mg (hazard ratio, 0.79; 95% confidence interval, 0.62 to 0.99) intravenous iron compared with.0–150 mg over 1 month was observed. There was no relation of 1-month intravenous iron dose with cardiovascular or infection related mortality and no relation of 3- or 6-month cumulative intravenous iron dose with all-cause or cardiovascular mortality. There was a nonstatistically significant increase in infection-related mortality with receipt of.1050mg intravenous iron in 3 months (hazard ratio, 1.69; 95%confidence interval, 0.87 to 3.28) and.2100mg in 6 months (hazard ratio, 1.59; 95% confidence interval, 0.73 to 3.46). Conclusions Among patients on incident dialysis, receipt of #1050 mg intravenous iron in 3 months or 2100 mg in 6 months was not associated with all-cause, cardiovascular, or infection-related mortality. However, nonstatistically significant findings suggested the possibility of infection-related mortality with receipt of.1050 mg in 3 months or.2100 mg in 6 months. Randomized clinical trials are needed to assess the safety of exposure to greater cumulative intravenous iron doses.

AB - Background and objectives Clinical trials assessing effects of larger cumulative iron exposure with outcomes are lacking, and observational studies have been limited by assessment of short-term exposure only and/or failure to assess cause-specific mortality. The associations between short- and long-term iron exposure on all-cause and cause-specific mortality were examined. Design, setting, participants, & measurements The study included 14,078 United States patients on dialysis initiating dialysis between 2003 and 2008. Intravenous iron dose accumulations over 1-, 3-, and 6-month rolling windows were related to all-cause, cardiovascular, and infection-related mortality in Cox proportional hazards models that used marginal structural modeling to control for time-dependent confounding. Results Patients in the 1-month model cohort (n=14,078) were followed a median of 19 months, during which there were 27.6% all-cause deaths, 13.5% cardiovascular deaths, and 3% infection-related deaths. A reduced risk of all-cause mortality with receipt of.150–350 (hazard ratio, 0.78; 95% confidence interval, 0.64 to 0.95) or.350 mg (hazard ratio, 0.79; 95% confidence interval, 0.62 to 0.99) intravenous iron compared with.0–150 mg over 1 month was observed. There was no relation of 1-month intravenous iron dose with cardiovascular or infection related mortality and no relation of 3- or 6-month cumulative intravenous iron dose with all-cause or cardiovascular mortality. There was a nonstatistically significant increase in infection-related mortality with receipt of.1050mg intravenous iron in 3 months (hazard ratio, 1.69; 95%confidence interval, 0.87 to 3.28) and.2100mg in 6 months (hazard ratio, 1.59; 95% confidence interval, 0.73 to 3.46). Conclusions Among patients on incident dialysis, receipt of #1050 mg intravenous iron in 3 months or 2100 mg in 6 months was not associated with all-cause, cardiovascular, or infection-related mortality. However, nonstatistically significant findings suggested the possibility of infection-related mortality with receipt of.1050 mg in 3 months or.2100 mg in 6 months. Randomized clinical trials are needed to assess the safety of exposure to greater cumulative intravenous iron doses.

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