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Final efficacy and safety results of the DRIVE study were presented by Daniel Coyne9 and
John Moran et al10 during Renal Week 2006 in
San Diego, California. Additional related studies were also presented during the
poster session.
Hobbs et al11 found serum
ferritin to be a volatile and unreliable measure of iron status in the DRIVE study,
suggesting that serum ferritin values may have limited usefulness in guiding iron
therapy in anemic hemodialysis patients with higher elevations in serum ferritin.
T. Kapoian12 and colleagues,
in an extension study of DRIVE, found that a course of Ferrlecit® therapy safely
reduces epoetin dose requirements in anemic hemodialysis patients with elevated
serum ferritin levels.
Ajay Singh13 suggests, based
on outcomes from the DRIVE study, that the use of reticulocyte hemoglobin content
(CHr) in hemodialysis patients needs to be re-evaluated. Currently, the KDOQI guidelines
recommend that CHr be maintained at >29 pg/cell. Interestingly, in the DRIVE
study, patients with CHr >31 pg/cell were more likely to respond to IV iron therapy
than patients with CHr ≤31 pg/cell, suggesting that CHr may not be a reliable
marker of iron status in hemodialysis patients with elevated serum ferritin levels.
 REFERENCES
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Important Safety Information3
Ferrlecit® is indicated for the treatment of iron deficiency anemia in chronic
hemodialysis patients age 6 years and over receiving supplemental epoetin therapy
• Ferrlecit® is contraindicated in non iron-deficient anemias, in patients
hypersensitive to Ferrlecit® or its inactive components, or with evidence of
iron overload • Hypersensitivity reactions have been reported with injectable
iron products • Hypotension has been reported with rapid administration of
IV iron • In a single-dose, placebo-controlled safety study (n=1097), the most
frequent adverse events occurring after Ferrlecit® administration were hypotension,
nausea, and vomiting and/or diarrhea • In multiple-dose studies (n=126), the
most frequent adverse events, whether or not related to Ferrlecit® administration
were nausea, vomiting and/or diarrhea, injection site pain, hypotension, cramps,
hypertension, dizziness, dyspnea, and chest pain
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