Superior to oral iron

Van Wyck DB, Roppolo M, Martinez CO, Mazey RM, McMurray S, for the United States Iron Sucrose (Venofer®) Clinical Trials Group. A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD. Kidney Int. 2005;68:2846-2856

Background:
An open-label, multicenter study of 182 non-dialysis dependent chronic kidney disease (NDD-CKD) patients with or without an erythropoiesis stimulating agent (ESA) randomized to receive either oral iron (325 mg ferrous sulfate TID for 56 days) or Venofer® ([iron sucrose injection, USP] either 200 mg IV push over 2 to 5 minutes 5 times within 14 days or 500 mg infusions over 3.5 to 4 hours on day 0 and day 14).

Measures:
Patients were randomized to receive either oral iron (325 mg ferrous sulfate TID for 56 days) or Venofer® either 200 mg IV push over 2 to 5 minutes 5 times within 14 days or 500 mg infusions over 3.5 to 4 hours on day 0 and day 14.

Primary endpoint was an increase in Hb of at least 1.0 g/dL at any time between baseline and either the end of study or withdrawal.

Secondary end points included the observed increase in Hb, TSAT, ferritin, and reticulocyte hemoglobin content (CHr) after treatment.

Adherence to prescribed treatments and adverse events were recorded for both treatment groups.

Results:

  • 44.3% of patients in the Venofer® group achieved a rise in Hb ≥1.0 g/dL (primary end point) vs 28.0% of patients receiving oral iron (P=.0344)
  • Mean increase in Hb was higher in the Venofer® group by day 42 (0.7 vs 0.4 g/dL, respectively, P=.0298)
  • Mean adherence was greater in the Venofer® group (97.3%) compared to oral iron group (88.5%)
  • No serious adverse events observed in patients receiving 200 mg IV iron doses
  • Of the 30 patients who received 500 mg IV iron infusion, 2 experienced hypotension; one of which was considered serious

IV iron but not oral iron combines success both in treating anemia and replenishing iron stores



Conclusions:
Administration of 1000 mg of Venofer® (iron sucrose injection, USP) in divided doses is superior to oral iron therapy in the management of NDD-CKD patients with anemia and low iron indices. Venofer® is safe, well tolerated, and more effective than oral iron treatment.

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IMPORTANT SAFETY INFORMATION:

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer® (iron sucrose injection, USP). Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. If hypersensitivity reactions or signs of intolerance occur during administration, stop Venofer® immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Venofer® administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Venofer® when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.

Venofer® may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Venofer®. Hypotension following administration of Venofer® may be related to rate of administration and total dose delivered.

Venofer® is contraindicated in patients with known hypersensitivity to Venofer®. Do not administer to patients with evidence of iron overload.

In efficacy studies in non-dialysis dependent-CKD patients (N=139), the most frequent adverse events (≥5%) whether or not related to Venofer® administration, were nausea (8.6%), taste disturbance

(7.9%), peripheral edema (7.2%), diarrhea (7.2%), dizziness (6.5%), hypertension (6.5%), infusion site pain or burning (5.8%), dyspnea (5.8%), and vomiting (5.0%).

In multi-dose efficacy studies in HDD-CKD patients (N=231), the most frequent adverse events (> 5%) whether or not related to Venofer® administration, were hypotension (39.4%), muscle cramps (29.4%), nausea (14.7%), headache (12.6%), graft complications (9.5%), vomiting (9.1%), dizziness (6.5%) hypertension (6.5%), chest pain (6.1%), and diarrhea (5.2%). In the study of PDD-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer®, reported by ≥5% of these patients were infections and infestations (nasopharyngitis, sinusitis, upper respiratory tract, pharyngitis) (16.0%), diarrhea (8.0%), vomiting (8.0%), hypertension (8.0%), peripheral edema (5.3%), and nausea (5.3%).


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