Background: The objectives of the present trial were to compare the side effects and safety of two intravenous iron preparations (iron-dextran, iron-sucrose) in patients with end stage renal disease.
Methods: A total of 60 patients were randomized and assigned to one of two treatment groups (iron-dextran, n = 30; iron-sucrose, n = 30). A standard test dose of 25 mg of low molecular weight iron-dextran and iron-sucrose were administered over 15 minutes during the initial visit, monitoring very closely for adverse reactions. If this dose was well tolerated, 75 mg of iron diluted in 100 mL of normal saline was administered over 30 minutes. Adverse reactions were recorded.
Results: The mean age of the patients was 51.5+/-17.4 years (range, 21 to 80 years). Of the 30 patients who received low molecular weight iron-dextran, 11 developed side effects (pruritus, 1 patient; wheezing, 1 patient; chest pain, 1 patient; nausea, 4 patients; hypotension, 1 patient; swelling, 1 patient; headache, 2 patients). Of the 30 patients who received iron-sucrose, 13 developed side effects (pruritus, 1 patient; wheezing, 1 patient; diarrhea, 1 patient; nausea, 4 patients; hypotension, 2 patients; swelling, 1 patient; headache, 3 patients). Adverse events occurred with similar frequency in the two treatment groups in our study (p > 0.05). We did not observe any serious reactions in the two groups.
Conclusion: We conclude that the incidence of side effects associated with iron-dextran was not different than that of iron-sucrose in our study. Large scale randomized studies are needed to compare the full side effect profile of intravenous iron preparations more precisely.