Last updated on April 21, 2014 at 7:52 EDT

Evaluation of a Single 1.000 mg Iron Dose as Ferric Carboxymaltose (FCM) for Fatigue Treatment in Iron Deficient Women – PREFER

June 14, 2012

AMSTERDAM, June 15, 2012 /PRNewswire/ –

Dr Micheal Hedenus of the Haematology Unit of the Sundsval Hospital in Sweden will
present promising results on a study on a single iron dose for fatigue treatment in iron
deficient women at the 17th Congress of the European Hematology Association in Amsterdam.

Fatigue and iron deficiency are prevalent among women of childbearing age. This
randomised, placebo-controlled study evaluated the effect of a single intravenous 1.000 mg
iron dose as ferric carboxymaltose (FCM, Ferinject(R), Vifor Pharma, Switzerland) on
fatigue symptoms in 294 non-anaemic, iron-deficient but otherwise healthy women with
moderate-to-severe fatigue (Piper Fatigue Scale total score greater than or equal to5).
Fatigue symptoms were assessed before and 7, 28, and 56 days after treatment. The fatigue
score improved significantly more often in FCM- than placebo-treated patients (65.3% vs.
52.7%; p=0.03) and twice as many women in the FCM than in the placebo group (33% vs. 16%;
p<0.001) achieved a 50% reduction in their fatigue. Notably, a difference in the median
fatigue score was seen from Day 7 onwards. In addition to the total fatigue score, all
subscores as well as mental quality of life and self-rated alertness, contentment and
calmness improved in the FCM-treated women. Side effects were reported by 49% of placebo-
and 57% of iron-treated women. Overall, a single well-tolerated dose of ferric
carboxymaltose (1,000 mg iron) rapidly and effectively replenished iron stores and reduced
fatigue symptoms in non-anaemic women with fatigue and iron deficiency. The results
suggest that patients with fatigue and iron deficiency without anemia may benefit from
iron replacement.

About the EHA Annual Congress

After 16 congresses and constantly increasing number of delegates, the 17th Congress
of EHA is taking place in Amsterdam. Hematology is a specialty that covers everything to
do with blood: its origin in the bone marrow, diseases (in the production) of blood and
their treatments. The latest data on research and developments within the wide spectrum of
hematology are presented.

SOURCE European Hematology Association

Source: PR Newswire