Findings published in International Urology and Nephrology suggest that the use of high-dose parenteral iron is not associated with a higher risk for infection, all-cause mortality, increased hospitalization or increased cardiovascular events.
According to the study, effective production of red cells and optimization of hemoglobin among patients with end-stage renal disease require continuing monthly iron infusion, but the safety of iron has been extensively debated. Moreover, it is still unclear whether parenteral iron is associated with an increased risk for infection and mortality.
Currently, IV iron transfusions are not given to patients on dialysis if an infection is suspected or confirmed. However, this can result in iron deficiency and low hemoglobulin, which is associated with increased blood transfusions and a higher mortality rate, according to researchers.
“From currently available data, there is no need for routinely withholding parental iron in patients on dialysis with sepsis who are severely iron deficient unless they have septicemia with shock requiring ICU level of care,” Sohail Abdul Salim, MD, FACP, FASN, FSSCI, from the division of nephrology at the University of Mississippi Medical Center, told Infectious Disease News.
Salim, Raghavendra Tirupathi, MD, FACP, medical director of Keystone Infectious Diseases/HIV, chair of infection prevention at Summit Health and clinical assistant professor of medicine at Penn State University, and colleagues conducted a meta-analysis investigating the incidence of infectious complications, hospitalizations and mortality associated with parenteral iron use.
The final analysis included seven randomized controlled trials (RCTs) and 16 observational studies. According to Tirupathi, the study’s strengths are the “very large sample size and longer follow-up periods.”
However, Salim did note that other populations require further study.
“More trials with larger sample size involving minorities like African Americans are needed at this time to draw more accurate conclusions in those cohorts,” he said.
Although not statistically significant, six of the RCTs reported that high-dose IV iron resulted in 17% less all-cause mortality compared with controls (OR = 0.83; 95% CI, 0.07-1.01). The overall HR calculated from nine observational studies demonstrated an increased risk for all-cause mortality in the high-dose group, but this, too, was not statistically significant (HR = 1.1; 95% CI, 1-1.22).
In a fixed-effect model using infection rate data from four RCTs, the researchers observed no difference in the infection rate between those receiving high-dose iron and the control group. The summary HR for eight observational studies demonstrated an “increased yet insignificant risk” for infection among patients receiving high-dose iron (HR = 1.13; 95% CI, 0.99-1.28).
Finally, the researchers reviewed one RCT that reported a 22.3% rate of adverse cardiovascular events among patients receiving high-dose iron compared with 25.6% among patients receiving low-dose iron (P = .12). Similarly, data from six observational studies reported no significant differences between patients receiving high-dose iron and controls (HR = 1.18; 95% CI, 0.89-1.57).
“This study answers the difficult but important question about whether IV iron should be used among patients with ESRD and weighs the benefits vs. risks with an extensive review of literature of seven RCTs and 16 observational studies. There was no statistically significant increase risk of infections or mortality by the fixed effect model,” Tirupathi said. “This in turn could change the current practice of unnecessarily holding parenteral iron due to concern for worsening infection.” – by Marley Ghizzone
Disclosures: The authors report no relevant financial disclosures.