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Visit www.ivironbreakingnews.com
to view
Breaking News in IV Iron Management: DRIVE
Join Daniel Coyne, MD, as he shares the results of an important clinical trial,
Dialysis Patients’ Response to IV Iron with Elevated Ferritin (DRIVE). The
DRIVE study addresses the challenge of treating anemia in hemodialysis patients
with elevated serum ferritin and low TSAT despite adequate epoetin therapy, a particularly
difficult problem for nephrology clinicians.
Daniel Coyne is Professor of Medicine at Washington University School of Medicine,
St. Louis, Missouri, and lead investigator of the DRIVE study.
Disclosure
Consultant for Abbott, Roche, Watson Laboratories; Advisor for Amgen; Speaker for
Abbott, Amgen, Watson Laboratories; Research support from Abbott, Advanced Magnetics,
Amgen, Roche, Watson Laboratories.
REFERENCES
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Key Findings2
Mean TSAT at baseline
was below the target level recommended by the KDOQI guidelines.
Mean CHr at baseline
was above the target recommended by the KDOQI guidelines (>29 pg/cell).
~79% of patients had
abnormally high CRP levels at baseline(normal CRP is <5 mg/L), indicating presence
of inflammation.5
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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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