Comparison of Intravenous Iron Sucrose to Oral Iron in the Treatment of Anemic Patients with Chronic Kidney Disease Not on Dialysis

Abstract

Background: Few studies compare oral to intravenous (IV) iron for managing anemia in patients with chronic kidney disease (CKD) not on dialysis. Methods: We enrolled 96 CKD anemic patients on erythropoietin in a randomized, open-label, multicenter, controlled study. Patients received 29 days of oral FeSO₄ (325 mg t.i.d.) or intravenous (IV) iron sucrose (5 doses of 200 mg weekly). Assessments were made up to 14 days after the last dose. Primary endpoints were changes in hemoglobin and ferritin, and clinical success was evaluated from the percent of patients with combined endpoints of rises in hemoglobin/ferritin, hemoglobin/ferritin/TSAT, and hemoglobin/TSAT. Results: There was no significant difference in hemoglobin values between IV and oral therapy. IV iron patients had greater increases in mean serum ferritin (288 ng/ml, p < 0.0001) compared to oral iron patients (–5.1 ng/ml, p = NS). IV iron patients with baseline ferritin <100 ng/ml had a greater increase in hemoglobin (1.4 g/dl) compared to oral iron patients (0.9 g/dl) (p < 0.05). More IV iron patients (54.2%) attained hemoglobin values >11.0 g/dl compared to oral iron patients (31.3%, p = 0.028), and met hemoglobin/ferritin (62.5%), hemoglobin/TSAT (47.9%), hemoglobin/ferritin/TSAT (43.8%), and ferritin/TSAT criteria (54.2%) than oral iron patients (0, 22.9, 0, and 0%, respectively). There were no serious side effects. Conclusions: These CKD patients had increases in both hemoglobin and ferritin following IV iron therapy, whereas those treated with oral iron had increases in hemoglobin without increases in iron stores. Iron sucrose, given weekly as 200 mg IV push over 5 min is an effective and safe anemia treatment in this population.

Iron Metabolism, Iron Deficiency, Thrombocytosis, and the Cardiorenal Anemia Syndrome

“…iron therapy, whereas those treated with oral iron had smaller increases in Hb but without increases in iron stores. Iron sucrose was found to be an effective and safe anemia treatment in this population [30].…”

“…In contrast to such severe anemia, two other trials (both involving iron sucrose), in which patients had higher initial Hb levels of 9.7-9.8 g/dl or 9.9 g/dl, also found a statistical difference between i.v. and oral iron preparations [30,31]. In the first study, clinical success following weekly 200-mg i.v.…”

Comparative Study of Intravenous Iron Sucrose Versus Oral Iron Therapy in Iron Deficiency Anemia During Postpartum Period

“…In 2005, the FDA approved iron sucrose for the treatment of iron deficiency anemia in predialysis in chronic kidney disease (CKD) patients with or without an erythropoietin. Data from one study found IV iron sucrose to be superior to oral iron therapy in the treatment of anemia of CKD (Charytan et al 2005) 16 . In the first trial, 96 adults in CKD patients with anemia (Hb < 10.5 g/dl, TSAT < 25%, and ferritin < 300 ng/ml) were randomized to ferrous sulfate 325 mg three times daily or iron sucrose 200 mg by IV injection once weekly for five weeks.…”

Iron sucrose – characteristics, efficacy and regulatory aspects of an established treatment of iron deficiency and iron-deficiency anemia in a broad range of therapeutic areas

“…iron products). Among the 36 published clinical studies [45][46][47][48][49][50][55][56][57][58][59][60]64,65,70,74,[76][77][78][79][80][81][82][83][84][85][86][87][88][89][90][91] that are included in the clinical dossier of Venofer, 26 reported at least some details about adverse drug events; 3 of those reported at least possibly related serious adverse events (all nonfatal, Table 2) [51,76,77]. Three reports included only general statements on safety without further details (e.g., no serious adverse reactions were noted) [47,48,64].…”