SAFETY AND EFFICACY OF IV SODIUM FERRIC GLUCONATE COMPLEX IN PATIENTS WITH CHRONIC KIDNEY DISEASE Claudia Beals, MD John Detesco Erdal Sarac, MD FACP FASN Department of Internal Medicine St. Elizabeth Health Center

Introduction Iron deficiency is common in Chronic Kidney Disease (CKD) patients Occurs for multiple reasons (GI loss, frequent blood testing,etc) To render IV iron therapy practical to CKD patients in a variety of settings, the range of iron doses and infusion rates should be both broad and safe. National Kidney Foundation Kidney Disease Outcomes Quality Initiative defines anemia as a Hgb<11.0 g/dL which affects approximately 75% of Non-Dialysis Dependent (NDD) CKD patients in the US.

IV vs. Oral Adverse reactions? Iron overload? Which one maintains iron stores?

Purpose The purpose of this study was to compare efficacy and safety of IV sodium ferric gluconate with that of oral iron in NDD patients with chronic kidney disease (CKD) in an outpatient office setting.

Methods Retrospective chart audit was undertaken on anemic patients being treated with iron (PO or IV) and ESP (Erythrocyte Stimulating Proteins) in a office setting. Patients were administered IV iron if serum ferritin level was < 100 or serum iron saturation <15%. Patients were treated with oral iron preparations if serum ferritin level was >100 or serum iron saturation >15%. Intravenous Ferrlecit 125mg was infused at a rate of 60 minutes once a week for six weeks (total 750mg). TIBC Ferritin, FE sat %, Hgb and Hct was compared to oral iron 325 mg TID at baseline in patients with CKD Laboratory values were collected at baseline, eight weeks and again at 12 weeks Iron studies for the two groups were compared

30 40 50 60 70 80 90 Age 5 10 15 20 Frequency Mean = 70.2 Std. Dev. = 12.391 N = 99

Χ2 = 1.43, p = 0.231

Baseline 8 weeks 12 weeks IV 42.3 + 4.1 72.3  6.8 76.7  5.8 Oral 50 100 150 Iron, Serum baseline Iron, Serum 8 weeks Iron, Serum 12 weeks Oral n = 88 IV n = 26 Baseline 8 weeks 12 weeks IV 42.3 + 4.1 72.3  6.8 76.7  5.8 Oral 65.9 + 2.9 71.3  3.5 70.2  3.2

TIBC Baseline 8 weeks 12 weeks 100 200 300 400 500 TIBC baseline TIBC 8 weeks TIBC 12 weeks Oral n = 88 IV n = 26 TIBC Baseline 8 weeks 12 weeks IV 284.3 + 19.1 284.5  15.1 287.9  19.9 Oral 268.0 + 7.5 263.1  6.1 266.0  6.8

Fe sat% Baseline 8 weeks 12 weeks 0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% Iron Saturation baseline Iron Saturation 8 weeks Iron Saturation 12 weeks Oral n = 88 IV n = 26 Fe sat% Baseline 8 weeks 12 weeks IV 14.2 +1.3 26.3  3.1 27.7  2.2 Oral 25.4 + 1.2 27. 7  1.5 27.0  1.4

Ferritin Baseline 8 weeks 12 weeks 300 600 900 1200 1500 Ferritin, Serum baseline Ferritin, Serum 8 weeks Ferritin, Serum 12 weeks Oral n = 88 IV n = 26 Ferritin Baseline 8 weeks 12 weeks IV 123.8 + 35.1 278.8  51.1 282.4  55.9 Oral 176.9 + 23.5 157.3  22.4 334.0 126.0

Hgb Baseline 8 weeks 12 weeks 8.0 9.0 10.0 11.0 12.0 13.0 14.0 HGB baseline HGB 8 weeks HGB 12 weeks Oral n = 88 IV n = 26 Hgb Baseline 8 weeks 12 weeks IV 10.4 +0.2 11.4  0.2 11.5  0.3 Oral 10.8 + 0.1 11.6  0.1 11.5  0.1

Hct Baseline 8 weeks 12 weeks 25.0 30.0 35.0 40.0 HCT baseline HCT 8 weeks HCT 12 weeks Oral n = 88 IV n = 26 Hct   Baseline 8 weeks 12 weeks IV 32.4 + 0.7 35.8  0.8 35.7  0.9 Oral 32.9 + 0.3 35.5  0.3 35.3  0.3

Conclusion IV Sodium Ferric Gluconate was more efficacious in CKD patients than oral Fe. High dose 750 mg of IV Sodium Ferric Gluconate can be safely administered as 125mg over 60 minutes without any severe Adverse Drug Reactions. ESP requirement was similar in both IV and PO iron therapy groups. Fe indices increased, with a dramatic increase in Hgb and Hct over the 12 week interval in IV therapy group. Oral Fe did not demonstrate significant changes in Hgb and Hct levels

Discussion Safety issues IV Sodium Ferric Gluconate does not require a test dose no fatal adverse effects has ever been reported oversaturation?

Discussion Efficacy IV vs. Oral IV iron better bioavailabilty better patient adherence Oral poor bioavailabilty ineffective erythropoesis poor patient adherence

Questions?

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