Iron sucrose and sodium ferric gluconate complex, the 2 most commonly used intravenous iron formulations in hemodialysis (HD) patients, display similar long-term safety, a new study finds.
Since iron formulations differ in their structure, pharmacologic stability, and pharmacokinetic properties, these differences might have influenced patient outcomes.
Wolfgang C. Winkelmayer, MD, MPH, ScD, of Baylor College of Medicine in Houston, and colleagues, mined the US Renal Data System to identify 2015 HD facilities that used ferric gluconate more than 90% of the time and 2015 using iron sucrose, matched by region. Of 51,603 total patients, 24,911 received iron sucrose and 26,692 ferric gluconate during 1999 to 2011. The groups were similar with respect to age, gender, race, comorbid conditions, body mass index, estimated glomerular filtration rate, average hemoglobin level, and dosages of erythropoiesis-stimulating agents.
Over 49,989 person-years of follow up, 10,381 patients died, including 3908 from cardiovascular and 1209 from infectious causes. Dr Winkelmayer’s team found no substantial differences in all-cause and cause-specific mortality between iron sucrose and ferric gluconate facilities in adjusted analyses, according to a report published online ahead of print in the American Journal of Kidney Diseases. In addition, among a subset of Medicare patients, the investigators found no significant differences in fatal and nonfatal cardiovascular events.
The researchers did find an 8% reduction in the relative hazards of infectious hospitalizations in patients receiving dialysis at centers that mostly use iron sucrose rather than ferric gluconate. They suggested a future randomized trial to probe any harmful or protective effects for the iron formulations, including by dose.
Central venous catheter usage and anaphylaxis rate were not assessed in the study and might have affected results, according to the researchers.
1. Winkelmayer WC, Goldstein BA, Mitani AA, et al. Safety of Intravenous Iron in Hemodialysis: Longer-term Comparisons of Iron Sucrose Versus Sodium Ferric Gluconate Complex. Am J Kidney Dis. doi: 10.1053/j.ajkd.2016.10.031. [Epub ahead of print]