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: Venofer® (iron sucrose injection, USP) is contraindicated in patients with evidence of iron overload, in patients with known hypersensitivity to VenoferŪ or any of its inactive components, and in patients with anemia not caused by iron deficiency. Serious hypersensitivity reactions have been reported in patients receiving VenoferŪ. In clinical studies, several patients experienced hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes, or pruritus. The post-marketing spontaneous reporting system includes reports of patients who experienced serious or life-threatening reactions (anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea, or convulsion) associated with VenoferŪ administration.

Hypotension has been reported frequently in non-dialysis dependent-CKD patients receiving IV iron. Hypotension following administration of VenoferŪ may be related to rate of administration and total dose delivered.

In a multi-dose efficacy study in non-dialysis dependent-CKD patients (N=91), the most frequent adverse events (≥5%) whether or not related to VenoferŪ administration, were taste disturbance (7.7%), peripheral edema (7.7%), diarrhea (5.5%), constipation (5.5%), nausea (5.5%), dizziness (5.5%), and hypertension (5.5%). In an additional study of VenoferŪ with varying erythropoietin doses in 96 treated NDD-CKD patients, adverse events, whether or not related to VenoferŪ reported by ≥5% of VenoferŪ exposed patients are as follows: diarrhea (16.5%), edema (16.5%), nausea (13.2%), vomiting (12.1%), arthralgia (7.7%), back pain (7.7%), headache (7.7%), hypertension (7.7%), taste disturbance (7.7%), dizziness (6.6%), extremity pain (5.5%), and injection site burning (5.5%).

In multi-dose efficacy studies in HDD-CKD patients (N=231), the most frequent adverse events (> 5%) whether or not related to VenoferŪ 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 post-marketing safety studies in HDD-CKD patients (N=1051), the most frequent adverse events reported (>1%), whether or not related to VenoferŪ administration, were congestive heart failure, sepsis, and taste disturbance. In the study of PDD-CKD patients (N=75), the most frequent adverse events, whether or not related to VenoferŪ, reported by ≥5% of these patients were diarrhea (8.0%), peritoneal infection (8.0%) vomiting (8.0%), hypertension (8.0%), pharyngitis (6.7%), peripheral edema (5.3%), and nausea (5.3%).


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