In this article, Venofer is compared to other iron preparations. The safety and efficacy of Venofer (iron sucrose) is compared to that of ferric gluconate in patients undergoing hemodialysis.

Van Wyck DB, Cavallo G, Spinowitz BS, Adhikarta R, Gagnon S, Charytan C, Levin N.

Cavill I

Dittrich E, Schillinger M, Sunder-Plassmann G, Horl WH, Vychytil A

Beshara S, Lundqvist H, Sundin Jet al.

Reviewed by: Roland Schaefer

Background: In most hemodialysis patients treated for anemia with rHuEPO, correction of iron deficiency requires the administration of intravenous (IV) iron. Iron dextran has a major drawback: a relatively high rate of life-threatening and fatal anaphylactoid reactions. Only limited data exist on the safety and efficacy of ferric gluconate and iron sucrose.

Methods: Fifty-nine stable hemodilaysis patients treated with rhuEPO and at maintenance phase of iron treatment were randomly assigned to iron sucrose (250 mg once per month; group I) and ferric gluconate (62.5 mg once per week; group II) over a period of 6 months. Iron administration was stopped when Hb concentration was >12.5 g/dL or serum ferritin was >1000 μg/L. Patients were closely monitored and were asked specific questions for symptoms typical of iron toxicity.

Results: Groups I and II showed no significant differences in Hb concentration, transferrin saturation, ferritin values, hypochromic red blood cells and rHuEPO dose requirements. In group I (n=27), 5 patients were discontinued because of Hb >12.5 g/dL and 3 patients because of serum ferritin >1000 μg/L. In group 2, 3 patients were discontinued because of Hb >12.5 g/dL and 1 patient because of serum ferritin >1000 μg/L. A slight, but not statistically significant decrease in rHuEPO dose requirements was observed in group I but not in group II. Platelet levels increased more in group I than in group II, and the difference in change was significant (p<0.05). Abnormally high values for leukocytes were observed in 23% of patients in iron gluconate group compared to 0% in iron sucrose group (p<0.05).

Conclusion: The authors conclude that iron sucrose at a higher dose of 250 mg once per month is equally effective and well tolerated as ferric gluconate at a lower dose 62.5 mg once weekly in stable hemodialysis patients in the maintenance phase of iron therapy.

• Annual blood loss from dialysis and blood sampling is estimated to be approximately 2,500 mL, representing an iron loss of at least 1,000 mg. Some studies evaluate this to up to 3,000 mg.
• rHuEPO treatment increases further the need for iron.
• During the phase of anemia correction in hemodialysis patients there is a need for approximately 600 mg of iron within 2-3 months to reach the target Hb concentration.
  
• During the maintenance phase, iron needs equal the loss, i.e. 1,000-3,000 mg/year.
  
• The study was performed in the maintenance phase of the iron treatment. Therefore, significant changes of the primary efficacy parameters were not expected. However, more patients receiving iron sucrose had to discontinue iron treatment because Hb exceeded 12.5 g/dL or ferritin 1000 ng/dL. This may be in favor of a more efficiency of a monthly perfusion of high doses of iron sucrose in comparison with weekly low doses of iron gluconate.
• There was a trend to lower rHuEPO doses in patients receiving iron sucrose in comparison with those receiving iron gluconate.
• Abnormal high values of leukocytes were only observed in the group receiving iron gluconate.
• There was no adverse event related to IV iron therapy.
• With similar good tolerability, in practice the administration of monthly high doses of iron sucrose is more convenient than weekly low doses of iron gluconate especially in patients on peritoneal dialysis and in predialysis patients.

• The small number of patients
• Open-labeled study.