Transcript FAIR-HF Trial: Ferric Carboxymaltose in Patients with - Iqanda-CME

The FAIR-HF Trial
Ferric carboxymaltose Assessment in Patients with Iron Deficiency and Chronic Heart
Failure
Reference
Anker SD. Ferric carboxymaltose in patients with heart failure and iron deficiency. N
Engl J Med. 2009;361:2436–2448.
Background
Patients with heart failure might be susceptible to development of iron deficiency
because of depletion of iron reserves or defective iron absorption and reduced
bioavailability of iron recycled in the reticuloendothelial system.
Aim
To determine whether treatment with intravenous iron (ferric carboxymaltose) would
improve symptoms in patients who had heart failure, reduced left ventricular ejection
fraction, and iron deficiency either with or without anemia.
Method
Study design: The FAIR-HF trial was a randomized, double-blind, multicenter study.
Study population: A total of 495 patients were enrolled in this study. Ambulatory
patients who had chronic heart failure of NYHA class II or III, a LVEF of 40–45% or less,
a hemoglobin level between 95 and 135 g/L and iron deficiency. Uncontrolled
hypertension, other significant heart diseases and inflammation were some of the
excluding factors.
Treatment regimen: Ferric carboxymaltose or saline was administered to the patients
randomly as an intravenous bolus injection of 4 ml. Dosing was done every week till
repletion of iron was achieved and after that every 4 weeks as maintenance therapy
after 8th or 12th week of initiation of therapy.
End point: The primary end point was a self-reported Patient Global Assessment (PGA)
form and NYHA functional class in the 24th week. Safety end points were serious and
non-serious adverse effects, hospitalization and death up to the 26th week of study.
Result
The evaluation of PGA forms showed much or moderate i.e., around 50%
improvement in the ferric carboxymaltose group as compared to the 28% in the
placebo group. 47% in the ferric carboxymaltose group had NYHA functional class I or
II as compared to 30% in the placebo group.
Conclusion
The administration of ferric carboxymaltose for a period of 24 weeks in patients with
chronic heart failure and iron deficiency with or without anemia showed improvement
in the symptoms, functional capacity and the quality of life. No additional side-effects
were observed during this time-span. This treatment was beneficial to both patients
with and without anemia.
The administration of ferric carboxymaltose in patients with chronic heart failure
and iron deficiency with or without anemia was beneficial.