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Iron deficiency commonly complicates anemia in patients with non-dialysis dependent-chronic kidney disease (NDD-CKD). Up to 40% of males and 85% of females with anemia and NDD-CKD show evidence of iron deficiency.1 With the recent safety controversy surrounding ESA therapy,2 the use of IV iron without ESAs may present an attractive and cost effective alternative for treating anemia. IV iron therapy can provide effective anemia management, even in the absence of an erythropoietin, in a substantial portion of these patients.

A stepwise approach to anemia management, with a trial of IV iron as primary therapy, followed by the addition of an ESA, if necessary, provides a practical option for anemia protocols, providing individualized, effective treatment and the lowest possible ESA dose. Efforts to develop and implement this type of protocol can have both significant clinical outcomes as well as economic benefits.3

In addition, The NKF-Kidney Disease Outcomes Quality Initiative (KDOQI) Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in CKD (discussed in more detail below) state that iron agents may serve as primary therapy for selected patients (particularly those with NDD-CKD) or as adjuvant therapy for those also undergoing treatment with an ESA. Administered as adjuvants to ESAs, iron agents prevent iron deficiency and serve to minimize the dose of ESA needed to achieve target-range Hb levels.4

Optimization of anemia management in NDD-CKD without ESA therapy
The efficacy of IV iron as primary therapy in anemic patients with non-dialysis dependent-CKD has been studied in 5 clinical trials.5-9 Maintaining iron stores with Venofer® (iron sucrose injection, USP) may allow avoidance or discontinuation of ESA therapy. Clinical trials have shown that in up to one-third of non-dialysis dependent-CKD patients with iron deficiency anemia, treatment with Venofer® corrected anemia without an ESA.6,7 Results from all five clinical studies indicate a hematopoietic response, defined as a rise in Hb of >1 g/dL, in patients treated with IV iron alone. Approximately 1/3 to 1/2 of treated patients were able to reach the target Hb/hematocrit (HCT) defined during the studies.

Optimization of erythropoietin therapy
Aggressive intravenous iron therapy with products such as Venofer® is increasingly recognized as a means of optimizing the response to erythropoietin. Evidence from numerous studies10-20 conducted since 1992, totaling more than 450 patients, shows that intensive intravenous iron supplementation (iron dextran, iron sucrose, or sodium ferric gluconate in sucrose complex) allows a reduction in erythropoietin dose of 19% to 70%.

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%).


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References