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Intravenous iron supplementation practices and short-term risk of cardiovascular events in hemodialysis patients.

Kshirsagar AV, Freburger JK, Ellis AR, Wang L, Winkelmayer WC, Brookhart MA - PLoS ONE (2013)

Bottom Line: After adjustment, we found no significant associations of bolus dose versus maintenance, hazards ratio for composite outcome, 1.03 (95% C.I. 0.99, 1.07), or high dose versus low dose intravenous iron, hazards ratio for composite outcome, 0.99 (95% C.I. 0.96, 1.03).Strategies favoring large doses of intravenous iron were not associated with increased short-term cardiovascular morbidity and mortality.Investigation of the long-term safety of the various intravenous iron supplementation strategies may still be warranted.

View Article: PubMed Central - PubMed

Affiliation: University of North Carolina Kidney Center, UNC School of Medicine, Chapel Hill, North Carolina, United States of America.

ABSTRACT

Background & objectives: Intravenous iron supplementation is widespread in the hemodialysis population, but there is uncertainty about the safest dosing strategy. We compared the safety of different intravenous iron dosing practices on the risk of adverse cardiovascular outcomes in a large population of hemodialysis patients.

Design settings participants & measurements: A retrospective cohort was created from the clinical database of a large dialysis provider (years 2004-2008) merged with administrative data from the United States Renal Data System. Dosing comparisons were (1) bolus (consecutive doses ≥ 100 mg exceeding 600 mg during one month) versus maintenance (all other iron doses during the month); and (2) high (> 200 mg over 1 month) versus low dose (≤ 200 mg over 1 month). We established a 6-month baseline period (to identify potential confounders and effect modifiers), a one-month iron exposure period, and a three-month follow-up period. Outcomes were myocardial infarction, stroke, and death from cardiovascular disease.

Results: 117,050 patients contributed 776,203 unique iron exposure/follow-up periods. After adjustment, we found no significant associations of bolus dose versus maintenance, hazards ratio for composite outcome, 1.03 (95% C.I. 0.99, 1.07), or high dose versus low dose intravenous iron, hazards ratio for composite outcome, 0.99 (95% C.I. 0.96, 1.03). There were no consistent associations of either high or bolus dose versus low or maintenance respectively among pre-specified subgroups.

Conclusions: Strategies favoring large doses of intravenous iron were not associated with increased short-term cardiovascular morbidity and mortality. Investigation of the long-term safety of the various intravenous iron supplementation strategies may still be warranted.

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Related in: MedlinePlus

Cohort Identification.
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pone-0078930-g002: Cohort Identification.

Mentions: Figure 2 depicts the creation of our sample. Following the merge of the clinical and USRDS data, we first identified center-based, hemodialysis patients who had at least one TSAT measurement after undergoing dialysis for at least 9 months. The 9-month period accounted for the 6-month baseline period and an additional 3 months from the start of dialysis to allow for stability in the claims processing by the Centers for Medicare and Medicaid Services (CMS) [14]. Individuals with polycystic kidney disease were then excluded because of the low use of ESA’s or IV iron. Eligible patients could contribute more than one TSAT measurement. TSAT measurements were eligible if they occurred between January 30, 2004 (to allow assessment of lab values and medications in the last month of baseline) and November 30, 2008 (to allow for the 1-month exposure period and at least one day of follow-up).


Intravenous iron supplementation practices and short-term risk of cardiovascular events in hemodialysis patients.

Kshirsagar AV, Freburger JK, Ellis AR, Wang L, Winkelmayer WC, Brookhart MA - PLoS ONE (2013)

Cohort Identification.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3815308&req=5

pone-0078930-g002: Cohort Identification.
Mentions: Figure 2 depicts the creation of our sample. Following the merge of the clinical and USRDS data, we first identified center-based, hemodialysis patients who had at least one TSAT measurement after undergoing dialysis for at least 9 months. The 9-month period accounted for the 6-month baseline period and an additional 3 months from the start of dialysis to allow for stability in the claims processing by the Centers for Medicare and Medicaid Services (CMS) [14]. Individuals with polycystic kidney disease were then excluded because of the low use of ESA’s or IV iron. Eligible patients could contribute more than one TSAT measurement. TSAT measurements were eligible if they occurred between January 30, 2004 (to allow assessment of lab values and medications in the last month of baseline) and November 30, 2008 (to allow for the 1-month exposure period and at least one day of follow-up).

Bottom Line: After adjustment, we found no significant associations of bolus dose versus maintenance, hazards ratio for composite outcome, 1.03 (95% C.I. 0.99, 1.07), or high dose versus low dose intravenous iron, hazards ratio for composite outcome, 0.99 (95% C.I. 0.96, 1.03).Strategies favoring large doses of intravenous iron were not associated with increased short-term cardiovascular morbidity and mortality.Investigation of the long-term safety of the various intravenous iron supplementation strategies may still be warranted.

View Article: PubMed Central - PubMed

Affiliation: University of North Carolina Kidney Center, UNC School of Medicine, Chapel Hill, North Carolina, United States of America.

ABSTRACT

Background & objectives: Intravenous iron supplementation is widespread in the hemodialysis population, but there is uncertainty about the safest dosing strategy. We compared the safety of different intravenous iron dosing practices on the risk of adverse cardiovascular outcomes in a large population of hemodialysis patients.

Design settings participants & measurements: A retrospective cohort was created from the clinical database of a large dialysis provider (years 2004-2008) merged with administrative data from the United States Renal Data System. Dosing comparisons were (1) bolus (consecutive doses ≥ 100 mg exceeding 600 mg during one month) versus maintenance (all other iron doses during the month); and (2) high (> 200 mg over 1 month) versus low dose (≤ 200 mg over 1 month). We established a 6-month baseline period (to identify potential confounders and effect modifiers), a one-month iron exposure period, and a three-month follow-up period. Outcomes were myocardial infarction, stroke, and death from cardiovascular disease.

Results: 117,050 patients contributed 776,203 unique iron exposure/follow-up periods. After adjustment, we found no significant associations of bolus dose versus maintenance, hazards ratio for composite outcome, 1.03 (95% C.I. 0.99, 1.07), or high dose versus low dose intravenous iron, hazards ratio for composite outcome, 0.99 (95% C.I. 0.96, 1.03). There were no consistent associations of either high or bolus dose versus low or maintenance respectively among pre-specified subgroups.

Conclusions: Strategies favoring large doses of intravenous iron were not associated with increased short-term cardiovascular morbidity and mortality. Investigation of the long-term safety of the various intravenous iron supplementation strategies may still be warranted.

Show MeSH
Related in: MedlinePlus