Ferric Carboxymaltose Improves Iron-Deficiency Anemia in Renal Impairment

September 09, 2013

By Will Boggs, MD

NEW YORK (Reuters Health) Sep 09 - Ferric carboxymaltose (FCM) is as effective as iron sucrose for treating iron-deficiency anemia in patients with impaired renal function, according to results from the REPAIR-IDA trial.

"Based on our data, FCM should be considered a standard treatment option for patients with iron-deficiency anemia and impaired renal function," Dr. Jane E. Onken from Duke Clinical Research Institute, Durham, North Carolina told Reuters Health by email. "It allows higher doses of iron to be administered in fewer injections, an important factor when choosing a therapy."

FCM is an intravenous preparation that can be given in large single doses (750 mg) over short periods of time for a maximum treatment dose of 1500 mg. Earlier trials demonstrated its efficacy and tolerability in a variety of settings.

Here, Dr. Onken and colleagues compared the cardiovascular safety and efficacy of FCM and iron sucrose, both given IV, in 2,584 patients with iron-deficiency anemia and non-dialysis-dependent chronic kidney disease.

Most FCM patients (96.8%) received two infusions, and most iron sucrose patients (91.6%) received five infusions.

But the mean total dose of iron received was 1,464 mg in the FCM group and 963 mg in the iron sucrose group, the researchers reported online August 20th in Nephrology Dialysis Transplantation.

Hemoglobin concentrations increased by an average of 1.13 g/dL in the FCM group and by an average of 0.92 g/dL in the iron sucrose group, a difference that met the noninferiority criteria established for the study. The difference also met the unplanned endpoint for statistical superiority for the FCM regimen.

Mean hemoglobin increases were numerically greater for FCM than for iron sucrose across all subgroups and were noninferior for FCM compared with iron sucrose for all comparisons except Stage 2 chronic kidney disease.

The rate of the primary composite safety endpoint (all-cause death, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization, congestive heart failure requiring hospitalization or medical intervention, cardiac arrhythmia, and hypertensive or hypotensive events) was nonsignificantly higher in the FCM group (13.7% vs 12.1%).

The rate of drug-related treatment-emergent adverse events was also numerically but not significantly higher with FCM (23.4% vs 15.7%).

Hypertensive events were significantly more common in the FCM group, whereas hypotensive events were significantly more common in the iron sucrose group.

Patients in the FCM group experienced greater mean increases in alkaline phosphatase and gamma-glutamyl transpeptidase than did patients in the iron sucrose group.

Mortality during the study was similar in the two groups, at 1.2% with FCM and 1.4% with iron sucrose, but only one death was deemed possibly related to FCM. In that case, a patient with multiple comorbidities was found unresponsive at home one day after receiving a dose of FCM.

"Although a formal cost analysis was not performed in this study, FCM might be anticipated to provide a cost savings as it resulted in fewer office visits, etc.," Dr. Onken said.

The investigators note that "two non-US cost analyses comparing FCM and iron sucrose in patients with anemia due to inflammatory bowel disease both have demonstrated FCM to be more cost-effective than iron sucrose."

Dr. Onken would still use iron sucrose in some patients. "Hemodialysis patients who are routinely in the dialysis center for treatment of iron deficiency anemia are good candidates for iron sucrose," she said. "In these patients, vein patency and the assurance of visit compliance is not an issue."

"FCM offers many advantages (in spite of its higher acquisition price) but is not unique in doing that," Dr. Manuel Mu�oz from the University of Malaga in Spain, told Reuters Health in an email.

Dr. Mu�oz, who has published research on iron therapy for anemia, added, "Fortunately, other options are available."

For example, he said, newer IV iron preparations -- e.g., ferumoxytol and iron isomaltoside 1000, "the two closest competitors" -- allow relatively large doses of iron (500-1000 mg) to be given over 15-30 minutes in a single session.

The new study was funded by Luitpold Pharmaceuticals, Inc., which employed three of the 18 authors and had consulting relationships with three others.

SOURCE: http://bit.ly/1e9Pn7l

Nephrol Dial Transplant 2013.


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