Mar
2011

A hospital-based cost minimization study of the potential financial impact on the UK health care system of introduction of iron isomaltoside 1000.

Bhandari S

Ther Clin Risk Manag 2011;7:103-113.

NATA Rating :
Review by : M. Auerbach
NATA Review

This is an interesting paper that examines cost savings achieved by rapid administration of large doses of new parenteral iron preparations in Europe. It does not mention another new iron, ferumoxytol, capable of complete replacement dosing in a short single setting of 15 minutes, available only in the USA. There are errors in this paper. I believe there is a typographical error stating that the body requires 3 grams of elemental iron per day. The authors probably meant 3 mg. And, no publication in the last ten years suggests that low-molecular-weight (LMW) iron dextran (ID) be administered in 6 hours. Package inserts are not good references of clinical use. We just published the results of 1266 one-hour infusions of one gram of LMW ID without a serious adverse event. These data were presented in an educational session at the December 2010 American Society of Hematology annual meeting and recently published in manuscript form in the American Journal of Hematology.br>
It is much to soon to point out the differences between the maximal doses of ferric carboxymaltose and iron isomaltoside. The latter compound has tremendous potential but few prospective studies have been published. We are currently doing a phase I study in chemotherapy-induced anemia patients to see if iron isomaltoside can overcome some of the proscriptions on erythropoisis-stimulating agent usage that have been recently meted upon the oncology community.

This paper does not mention the hypophosphatemia that was described in the majority of patients who receive ferric carboxymaltose, a reason for its failure to be approved by the FDA in the USA. Ongoing safety trials are eagerly awaited. There is also the mention of intramuscular injection of LMW ID, an approved method. This painful, less effective, harder to administer method of giving iron, which causes permanent skin staining of the buttock and has been associated with gluteal sarcomas, has been proscribed by investigators in this field. Intramuscular administration of parenteral iron, irrespective of the companies\’ approvals, is cruel and should cease.

The conclusion of this paper should be that all three of these agents show promise to provide complete replacement dosing of iron in 15 minutes or less. All of us involved in clinical research with intravenous iron eagerly await the results of ongoing clinical trials.

– Michael Auerbach