Background: This study was undertaken to assess the safety and tolerability of the use of intravenous (IV) iron sucrose in the therapy of iron-deficiency anemia in elderly, hemodialysis-dependent (HDD), chronic kidney disease (CKD) patients. Methods: This was a multicenter, open-label study in a large consecutive sample of 665 HDD-CKD patients (in 11 locations). Patients received IV iron sucrose therapy in treatment and maintenance dosing cycles over 10-week periods. There were 10 doses of 100 mg of iron sucrose in each drug cycle, and participants could receive multiple cycles of either or both regimens. Variables evaluated in the intent-to-treat population included adverse events (AEs), hemoglobin, and iron indices. Results: Of the 665 patients, 391 patients were under the age of 65 (younger adults) and 274 were 65 years of age or older (elder adults). Iron needs and erythropoietin dosing were similar in both the elder and younger adult patients. The incidence, severity, and nature of AEs and overall mortality were similar in both age groups. There were no drug-related deaths or drug-related serious AEs in either group. There were no hypersensitivity reactions or allergic reactions in either patient population, even among those with a prior history of intolerance to other parenteral-iron products. Comparison of the two age groups also revealed no differences in the efficacy of iron treatment as reflected by hemoglobin, transferrin saturation, and ferritin response. Conclusions: There is no apparent difference in the safety and efficacy of iron sucrose between elder and younger adults in the treatment of iron-deficiency anemia in HDD patients with CKD. © 2007, American Society of Consultant Pharmacists, Inc. All rights reserved.
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