Efficacy Results | Hemoglobin Response
The Drive Study
 
 
IMPROVED HEMOGLOBIN RESPONSE
Patients receiving Ferrlecit® experienced significantly greater increases in Hb compared with those who did not receive IV iron (P = 0.028).
Patients who received Ferrlecit® achieved a greater Hb response than those who did not receive iron, regardless of baseline serum ferritin or TSAT.

HIGHER RESPONSE RATE
At 6 weeks, the proportion of patients with an Hb
increase of 32 g/dL was 61% higher in the Ferrlecit® group compared with the no-iron group.
In both serum ferritin strata, response rates were similar to those in the total study population.


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Key Points2

  A course of Ferrlecit® therapy(1 g given over 8 consecutive dialysis sessions) was effective management for anemic hemodialysis patients with serum ferritin 500-1200 ng/mL and TSAT ≤25% receiving adequate epoetin doses.

  Hemoglobin increases were greater following IV iron treatment compared to no iron therapy.

  Administration of Ferrlecit® in this patient population overcame functional iron deficiency and inflammation-mediated reticuloendothelial blockade.

  Withholding IV iron in these patients resulted in worsening of iron-restricted erythropoiesis.

 
 
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