The largest ever study of IV iron supplementation in patients with heart failure failed to meet a new rigorous definition of significance, and the results were generally regarded as disappointing.
This new indication for ferric carboxymaltose injection marks the first FDA approval of an intravenous iron replacement therapy for adult patients with heart failure, the company said.
The trial missed its primary endpoint, but makes unique contributions; many see it as further evidence that the treatment helps iron-deficient patients with heart failure.
The data from IRONMAN don t persuade this cardiologist that the additional burden outpatient iron infusions would place on patients with heart failure and low iron are worth it.
"The rates of anaphylaxis were very low with all IV iron products but were three- to eightfold greater for iron dextran and ferumoxytol than for iron sucrose."