Patients undergoing hemodialysis typically receive intravenous iron, despite a lack of established clinical efficacy. In this randomized controlled trial, investigators randomized 2141 patients undergoing hemodialysis to either high-dose iron sucrose, administrated proactively, or low-dose iron-sucrose, administered reactively to compare the safety and efficacy of these regimens in patients undergoing hemodialysis. The primary outcome examined was a composite of nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, or death. Researchers found that the high-dose group required a lower median monthly dose of erythropoiesis-stimulating agent (median difference -7539 IU, 95% CI -9485 IU to -5582 IU), and that more rapid increases in hemoglobin level were observed over time for the high-dose group. The composite end point occurred in 30.5% of the high-dose group compared to 32.7% of the low-dose group (HR 0.88, 95% CI 0.76 to 1.03, p<0.001 for noninferiority, p=0.11 for superiority). In terms of individual outcomes, the rate of death was 22.5% in the high-dose group compared to 25.7% in the low-dose group (HR 0.84, 95% CI 0.71 to 1.00). The rate of hospitalization for heart failure was significantly lower in the high-dose group (HR 0.66, 95% CI 0.47 to 0.93). Rates of serious adverse events and infection were similar between the two groups.
Taken together, the results from this study indicate that high-dose proactive intravenous iron regimens are non-inferior to low-dose reactive intravenous iron regimens, with some improved outcomes and reduced need for erythropoiesis-stimulating agents. This study was limited in that it was open-label and did not examine quality of-life data. The safety of the high-dose regimen also needs to be studied long term.
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