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A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent
David B Van Wyck1, Michael Roppolo, Carlos O Martinez
1University of Arizona College of Medicine, Tucson, AZ 85704-6128, USA. dvanwyck@sprynet.com
Insights
Intravenous (IV) iron sucrose is more effective than oral ferrous sulfate for treating anemia in nondialysis-dependent chronic kidney disease (ND-CKD) patients. IV iron led to greater hemoglobin increases and a slower decline in kidney function.
Area of Science:
- Nephrology
- Hematology
- Pharmacology
Background:
- Iron deficiency anemia is common in nondialysis-dependent chronic kidney disease (ND-CKD).
- The comparative efficacy of intravenous (IV) iron and oral iron for treating anemia in ND-CKD is not well-established.
Purpose of the Study:
- To compare the efficacy of IV iron sucrose versus oral ferrous sulfate in patients with ND-CKD.
- To evaluate treatment effects on hemoglobin levels and glomerular filtration rate (GFR).
Main Methods:
- A randomized, controlled multicenter trial compared 1g iron sucrose IV over 14 days with 325mg ferrous sulfate orally thrice daily for 56 days.
- Patients had ND-CKD stages 3-5, Hb ≤11 g/dL, TSAT ≤25%, and ferritin ≤300 ng/mL.
- Epoetin/darbepoetin therapy remained unchanged during the study.
Main Results:
- A higher proportion of patients achieved the primary outcome (Hb increase >1 g/dL) with IV iron (44.3%) compared to oral iron (28.0%, P=0.0344).
- Mean Hb increase by day 42 was greater with IV iron (0.7 g/dL) versus oral iron (0.4 g/dL, P=0.0298).
- Oral iron treatment group showed a greater decline in GFR (-4.40 mL/min/1.73m2) than the IV iron group (-1.45 mL/min/1.73m2, P=0.0100).
Conclusions:
- IV iron sucrose administration (1000 mg divided doses) is superior to oral iron therapy for managing anemia in ND-CKD patients with low iron indices.
- IV iron offers better hemoglobin response and preserves kidney function more effectively than oral iron in this patient population.
Background:
Although iron deficiency frequently complicates anemia in patients with nondialysis-dependent CKD (ND-CKD), the comparative treatment value of IV iron infusion and oral iron supplementation has not been established.
Methods:
In a randomized, controlled multicenter trial, we compared the efficacy of iron sucrose, given as 1 g in divided IV doses over 14 days, with that of ferrous sulfate, given 325 mg orally thrice daily for 56 days in patients with ND-CKD stages 3 to 5, Hb < or =11 g/dL, TSAT < or =25%, and ferritin < or =300 ng/mL. Epoetin/darbepoetin therapy, if any, was not changed for eight weeks prior to or during the study.
Results:
The proportion of patients achieving the primary outcome (Hb increase > or =1 g/dL) was greater in the IV iron treatment group than in the oral iron treatment group (44.3% vs. 28.0%, P= 0.0344), as was the mean increase in Hb by day 42 (0.7 vs. 0.4 g/dL, P= 0.0298). Compared to those in the IV iron group, patients in the oral iron treatment group showed a greater decline in GFR during the study (-4.40 vs. -1.45 mL/min/1.73m2, P= 0.0100). No serious adverse drug events (ADE) were seen in patients administered IV iron sucrose as 200 mg IV over two to five minutes, but drug-related hypotension, including one event considered serious, occurred in two females weighing less than 65 kg after 500 mg doses were given over four hours.
Conclusion:
IV iron administration using 1000 mg iron sucrose in divided doses is superior to oral iron therapy in the management of ND-CKD patients with anemia and low iron indices.
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