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.