For patients undergoing maintenance hemodialysis, a high-dose intravenous iron regimen administered proactively is noninferior to a low-dose intravenous iron regimen administered reactively, according to a study published online Oct. 26 in the New England Journal of Medicine to coincide with a presentation at the American Society of Nephrology's Kidney Week, held Oct. 23 to 28 in San Diego
Iain C. Macdougall, M.D., from King's College Hospital in the United Kingdom, and colleagues randomly assigned adults undergoing maintenance hemodialysis to receive high-dose iron sucrose, administered intravenously in a proactive manner, or low-dose iron sucrose, administered intravenously in a reactive manner. Overall, 2,141 patients were randomly assigned: 1,093 and 1,048 to the high- and low-dose groups, respectively.
Intravenous iron regimen
The researchers found that patients received a median monthly iron dose of 264 and 145 mg in the high- and low-dose groups, respectively. The median monthly dose of an erythropoiesis-stimulating agent was 29,757 and 38,805 IU in the high- and low-dose groups, respectively.
Overall, 30.5% of patients in the high-dose group and 32.7 percent of patients in the low-dose group had a primary end-point event (nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, or death; hazard ratio, 0.88; 95% confidence interval, 0.76 to 1.03; P < 0.001 for noninferiority).
"Given the absence of harm that was observed with the high-dose intravenous iron regimen in our trial, the safety and efficacy of even higher doses of iron might be explored in further trials," the authors write. Several authors disclosed ties to pharmaceutical companies, including Vifor Pharma, which partially funded the study.