High-dose intravenous (IV) iron does not appear to be associated with an elevated risk of infection, mortality, and other adverse events in patients on hemodialysis, a new meta-analysis suggests.

The meta-analysis, published in International Urology and Nephrology, included 8 randomized controlled trials (RCTs) and 16 observational studies. In an analysis of data from 4 RCTs and 8 observational studies that reported infection rates, Sohail Abdul Salim, MD, of the University of Mississippi Medical Center in Jackson, and colleagues found no statistically significant difference in infection rates between patients receiving high-dose IV iron and controls.

Data from 6 RTCs showed that high-dose IV iron conferred 17% lower odds of all-cause mortality compared with controls, and findings from 9 observational studies revealed a 10% increased risk of all-cause mortality. None of these differences were statistically significant, according to the investigators.

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One RCT and 6 observational studies provided data for all-cause hospitalization. The RCT found no statistically significant difference between high-dose iron and controls in the odds of hospitalization. The observational data showed an 11% increased risk of hospitalization among recipients of high-dose IV iron compared with controls, but this was not statistically significant. In addition, 1 RCT compared the rate of adverse cardiovascular events between high-dose and low-dose IV iron and found no significant difference (22.3% vs 25.6%). In 6 heterogeneous observational studies, investigators found no statistically significant difference in cardiovascular event risk between high-dose IV iron and controls.

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“To conclude, we found no evidence of excess infections, cardiovascular events, hospitalizations, or higher mortality associated with higher doses of IV iron in RCTs even though there was an increased trend of increased hospitalizations and infections in observational studies that were not statistically significant,” the authors wrote.


Salim SA, Cheungpasitporn W, Elmaraezy A, et al. Infectious complications and mortality associated with the use of IV iron therapy: a systematic review and meta-analysis [published online September 4, 2019]. Int Urol Nephrol. doi: 10.1007/s11255-019-02273-4