Improved anemia without the need for ESA

Mircescu G, Gârneata L, Capusa C, Ursea N. Intravenous iron supplementation for the treatment of anaemia in pre-dialyzed chronic renal failure patients. Nephrol Dial Transplant. 2006;21:120-124

Background:
A longitudinal open-label, single arm, prospective study to evaluate the effects of 1-year IV iron supplementation in pre-dialysis chronic renal failure (CRF) patients without absolute iron deficiency and not receiving concomitant erythropoiesis stimulating agent (ESA) treatment.

Sixty non-diabetic CRF patients, with stable blood pressure and stable renal function 1 month prior to the study (mean glomerular filtration rate, GFR, calculated using the Cockroft-Gault formula), with Hb < 11 g/dL and stable hematologic and iron status 1 month prior to inclusion, and without any concomitant erythropoietin treatment or previous iron therapy were enrolled.

Therapeutic intervention consisted of monthly IV administration of 200 mg of Venofer® (iron sucrose, USP) administered in 500 mL saline solution over 2 hours/per 100 mg during a period of 12 months for a total dose of 2400 mg.

Measures:

  • Parameters of erythropoietic response (Hb, hematocrit) were primary measures
  • Iron status, renal function, and blood pressure were designated as secondary parameters

Results:

  • Venofer® supplementation was associated with a significant increase in Hb (from 9.7±1.1 at the baseline to 11.3±2.5 g/dL after 12 months, a mean increase of 1.6 g/dL) (P< 0.05)
  • After 12 months of Venofer® administration and without any ESA, 55% of patients reached the recommended target Hb (11 g/dL)
  • There were significant increases in iron status (serum ferritin, transferrin saturation)
  • No worsening of renal function, no increase in blood pressure and no other side effects were observed



aStatistically significant vs baseline (P< 0.05).

Conclusions:

  • Hb, serum ferritin, and TSAT levels were significantly increased
  • Venofer® is an effective and safe treatment for anemia in pre-dialysis CRF patients, avoiding the need for erythropoietin or blood transfusions


Click here to request a copy of this article.


Back
American Regent. Enriching the lives of anemia patients. ™

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%).


Please see Full Prescribing Information.