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Mircescu G, Garneata L, Capusa C, Ursea N.
Nephrol Dial Transplant. 2006 Jan;21(1):120-4. Epub 2005 Sep 6.
BACKGROUND: Intravenous iron is a recognized therapy of anaemia in chronic haemodialyzed patients, especially in those receiving erythropoietin (Epo), while its role in the anaemia of pre-dialyzed chronic renal failure (CRF) patients is much less clear. This study attempted to evaluate the effects of intravenous iron in anaemic pre-dialyzed patients.
METHODS: Sixty anaemic (haemoglobin<11 g/dl) non-diabetic patients with moderate CRF [32 males, 28 females; mean age 52.2+/-12.5 years; mean glomerular filtration rate 36.2+/-5.2 ml/min], without iron deficiency, iron overload or inflammation, without concomitant erythropoietin treatment and without any previous iron therapy were enrolled. Intravenous iron was administered as iron sucrose, 200 mg elemental iron per month for 12 months, with 1 month pre-study survey and 1 month follow-up after the last iron dose.
RESULTS: Intravenous iron supplementation was associated with a significant increase in haemoglobin (from 9.7+/-1.1 at the baseline to 11.3+/-2.5 g/dl after 12 months, a mean increase of 1.6 g/dl), a further 36% of patients reaching the target haemoglobin of 10 g/dl. There was a significant increase in serum iron from 73.9+/-17.2 to 101.8+/-12.2 microg/dl, in serum ferritin from 98.0 (24.8-139.0) to 442.5 (86.0-496.0) microg/l and in transferrin saturation from 21.6+/-2.6 to 33.6+/-3.2%. No worsening of renal function, no increase in blood pressure and no other side effects were noted.
CONCLUSIONS: Intravenous iron therapy in pre-dialysis patients with no Epo seems often to ameliorate the anaemia, avoiding the necessity of Epo or blood transfusions in one-third of pre-dialyzed non-diabetic patients. Intravenous iron supplementation appears to be an effective and safe treatment for anaemia in pre-dialysis CRF patients.
In this longitudinal, open-label, single arm prospective study, Mircescu et al. evaluated the effect of IV iron supplementation in predialysis CRF patients without absolute iron deficiency and not receiving erythropoietin. In Romania, 89% of patients starting renal replacement therapy have Hb < 10 g/dL. Following the monthly administration of 200 mg IV iron sucrose, over one-third of patients who had Hb < 10 g/dL at baseline were able to attain Hb > 10 g/dL at 12 months, without the need for erythropoietin therapy. The authors conclude that IV iron supplementation is an effective and safe treatment for anemia in predialysis CRF patients.
ITO review
Reviewed by: Iain Macdougall
Design: Longitudinal, open-label, single arm prospective study. Period: 14 months, including one month pre-study assessment; 12 months therapeutic intervention, and one month follow-up. Setting: Nephrology center, Bucharest, Romania.
Background: Patients undergoing chronic hemodialysis (HD) often present with anemia. Intravenous (IV) iron therapy is administered to these patients as part of anemia management therapy, often in conjunction with erythropoietin (EPO). IV iron is used as an adjuvant therapy to EPO as it helps prevent EPO-hyporesponsiveness. With regard to patients with chronic renal failure (CRF) not yet on dialysis the role of IV iron therapy is less documented, although studies show that iron deficiency is a common cause of anemia in predialysis patients.
Overview
The Predialysis Survey on Anaemia Management (PRESAM) reported that 32% of predialysis patients had a hemoglobin concentration (Hb) > 11 g/dL which is the target set in the European Best Practice Guidelines (EBPG). Data from the Romanian Renal Registry echo this failure to meet target Hb: 89% of patients starting renal replacement therapy in Romania have Hb < 10 g/dL. Causes of iron deficiency in predialysis patients include reduced iron intake, reduced gastrointestinal iron absorption, GI bleeding, urinary loss of iron and reduced hemapoietic utilization of oral iron. Hepcidin also reduces intestinal iron absorption and may favor iron sequestration within cells of the reticulioendothelial system.
Unlike oral iron, IV iron bypasses the gastrointestinal tract and is therefore immediately available for erythropoiesis in the bone marrow and more rapidly converted into Hb. Studies show that not only does IV iron increase response to EPO, but that IV iron alone can correct anemia in patients with CRF, this allows for important cost savings.
In this study Mircescu et al. evaluated the effect of IV iron supplementation in predialysis CRF patients without absolute iron deficiency and not receiving EPO.
Methods: Sixty (32 men, 28 women; mean age 52.2) anemic (Hb <11 g/dL) non-diabetic CRF patients, with serum ferritin [SF] < 200 ng/mL and stable renal function (mean glomerular filtration rate, 36.2 MmL/min/1.73m?) were included in the study. CRF was due to primary glomerular nephropathies (60%), tubulointestinal disease (25%), nephroangiosclerosis (10%), and other renal diseases (5%). Exclusion criteria were: previous EPO therapy, absolute iron deficiency (SF < 20 ng/mL), iron overload (SF > 500 ng/mL), inflammation, gastrointestinal bleeding, significant weight loss, and folic acid or vitamin B12 deficiencies.
IV iron sucrose (Venofer®) 200 mg was administered monthly in 500mL saline over 2 hours (total 12 month dose: 2,400 mg).
Erythropoietic response, iron status and renal function parameters were assessed monthly, with SF being assessed every three months. There was a one month follow-up after the last iron dose.
Results: Fifty-eight patients completed the study. At the end of the 12 month study period the mean increase in Hb was 1.6 g/dL (from 9.7 ± 1.1 at the baseline to 11.3 ± 2.5 g/dL; p < 0.05), with 58% of patients reporting a rise in Hb > 1 g/dL vs. baseline; 80% of patients had a Hb > 10 g/dL vs. 44% at baseline (p < 0.05), and 55% had a Hb > 11 g/dL vs. 0% at baseline (P< 0.05). In other words, 36% of the patients who had Hb < 10 g/dL at baseline were able to attain target Hb of 10 g/dL with IV iron alone, with only 20% of patients failing to achieve this value.
Mean serum iron concentration increased from 73.9 µg/dL at baseline to 84.2 µg/dL at 6 months (p < 0.05) and 101.8 µg/dL at 12 months (p < 0.05). Mean transferrin saturation (TSAT) increased from 21.6 at baseline to 33.6% at 12 month (p < 0.05), with 97% of patients having TSAT > 20% at 12 months vs. 59% at baseline (p < 0.05). Mean SF increased from 98 to 442.5 ng/mL (p < 0.05), and 76% of patients had SF > 100 ng/mL at 12 months compared to only 50% at baseline (p < 0.05).
No worsening of renal function, no increase in blood pressure and no adverse events were reported.
Conclusion: IV iron sucrose alone enables the correction of anemia in over a third of anemic predialysis patients with CRF. IV iron is associated with a significant (p < 0.05) and progressive increase in Hb, with 80% of patients achieving Hb > 10 g/dL and 55% achieving Hb > 11 g/dL, 76% reaching SF > 100 ng/mL, and 97% reaching TSAT > 20% without the need for EPO therapy.
The authors conclude that IV iron supplementation is an effective and safe treatment for anemia in predialysis CRF patients.
Key Points
· 89% of patients starting renal replacement therapy in Romania have Hb < 10 g/dL.
· IV iron sucrose alone (200 mg per month) results in a significant hematological response in predialysis CRF patients, with a mean increase in Hb of 1.6 g/dL (from 9.7 ± 1.1 at the baseline to 11.3 ± 2.5 g/dL after 12 months of treatment; p < 0.05).
· IV iron sucrose alone (200 mg per month) enabled 55% of patients to attain a Hb > 11 g/dL, with 36% of patients with Hb < 10g/dL at baseline reaching Hb > 10 g/dL after 12 months thus 80% achieving Hb > 10 g/dL.
No worsening of renal function, and no adverse events were reported.
Limitations
Single-arm study with no control group.