A single 1,000 mg dose of Ferinject® rapidly improves fatigue symptoms in iron deficient, non-anaemic women
Tuesday, 17 April 2012, ↓ directly to download
Results of a new clinical study show that a single 1,000 mg dose of the intravenous iron treatment Ferinject® rapidly improves fatigue in symptomatic iron deficient, non-anaemic women.1 The results of the PREFER study, the first clinical trial to evaluate the efficacy and safety of Ferinject® in iron deficient, non-anaemic women of child bearing age suffering from unexplained fatigue, were reported on 16 April 2012 at a symposium at the German Society of Internal Medicine (DGIM) Congress in Wiesbaden.
Fatigue is often the main complaint when patients visit doctors in primary care and is a persistent symptom of various illnesses.2-6 According to several studies, women appear to be up to three times more affected by fatigue than men.7,8 Iron deficiency, a condition also common in women,9 can have clinical manifestations such as fatigue10-12 even before anaemia has developed.13 Several studies have suggested that treatment of iron deficiency can relieve fatigue symptoms.10,12
The PREFER study assessed the efficacy and safety of a single intravenous 1,000 mg dose of Ferinject® (ferric carboxymaltose) compared with placebo in 290 iron deficient, non-anaemic, pre-menopausal women with fatigue symptoms as determined by the Piper Fatigue Scale (PFS) score (a self-assessment of fatigue levels on a scale from 0 to 10, with 0 correlating to no fatigue). The study conducted across four European countries (Austria, Germany, Sweden and Switzerland) showed that Ferinject® reduced fatigue symptoms by more than a third in iron deficient, non-anaemic women.
The median total PFS score fell from 6.36 at baseline to 4.16 at day 56 for those women who received Ferinject®, which is a reduction of 34.6%, and from 6.41 to 5.20 for those women who received placebo, which is a reduction of 18.9% (p<0.001).1 In addition, 65.3% of the 144 women who received Ferinject® had a relevant individual response ≥1 point decrease in their PFS score from baseline to day 56 compared with 52.7% of the 146 who received placebo (p=0.03).1
Furthermore, Ferinject® rapidly reduced fatigue symptoms, showing a significant decrease just 7 days after treatment initiation (the median PFS score fell 12.7% from 6.36 at baseline to 5.55 for those women who received Ferinject®, and 8.7% from 6.41 to 5.85 for those women who received placebo; p<0.039).1 Ferinject® also replenished iron stores effectively and consistently.1 At day 56, almost all (99.3%) of the women who received Ferinject® had their serum ferritin levels restored to normal (≥50 ng/mL), compared with 2.1% who received placebo, and 76.4% (placebo 32.9%) had a transferrin saturation (TSAT) of ≥20%.1 The PREFER study also demonstrated that Ferinject® was well tolerated in this study population.1
“This large, controlled clinical study demonstrates that a single 1,000 mg dose of iron as ferric carboxymaltose can effectively reduce fatigue symptoms in iron deficient but otherwise healthy women. The correlation between baseline ferritin levels and Piper Fatigue Scale score improvement emphasises the importance of maintaining a normal iron status independent of haemoglobin levels,” said Dr Bernard Favrat, Senior Lecturer in the Department of Ambulatory Care and Community Medicine at the University of Lausanne, Switzerland, and principal investigator of the PREFER study.
The results of PREFER will be submitted for publication in a peer-reviewed journal and have been accepted for a poster presentation at the 10th International Scientific Meeting of the Royal College of Obstetricians and Gynaecologists (RCOG), 5-8 June 2012, and the FIGO World Congress of Gynaecology & Obstetrics, 7-12 October 2012. They have also been submitted to the 17th Congress of the European Haematology Association (EHA), June 14-17, 2012.
Vifor Pharma, a company of the Galenica Group, is a world leader in the discovery, development, manufacturing and marketing of pharmaceutical products for the treatment of iron deficiency. The company also offers a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products. Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global presence and a broad network of affiliates and partners around the world.
PREFER was a large multicentre randomised placebo-controlled study of 290 iron-deficient non anaemic (haemoglobin ≥11.5 g/dL, serum ferritin <50 ng/mL and transferrin saturation <20%, or serum ferritin <15 ng/mL) healthy women across four European countries (Austria, Germany, Sweden and Switzerland). The primary objective of the study was to assess the efficacy and safety of a single intravenous dose of ferric carboxymaltose (1,000 mg iron) compared with placebo in improving fatigue symptoms 56 days after administration. The PREFER study also demonstrated that Ferinject® was well tolerated in this study population.1 There was a total of 209 adverse events in the drug therapy group compared to 114 events with placebo. Most of the events were assessed to be mild or moderate.1
Ferinject® is an innovative non-dextran intravenous iron (i.v.) replacement therapy discovered and developed by Vifor Pharma, a company of the Galenica Group. Ferric carboxymaltose is the active pharmaceutical ingredient of Ferinject®. To date, Ferinject® has gained marketing authorisation in 38 countries worldwide for the treatment of iron deficiency where oral iron is ineffective or cannot be used. In many countries, intravenous iron replacement products are primarily used to treat dialysis patients. However, iron deficiency is also a complication of many other illnesses. Vifor Pharma is evaluating new opportunities in the treatment of iron deficiency with Ferinject® in different therapeutic areas. Further clinical trials with Ferinject® in chronic kidney disease (CKD), oncology (anaemia in cancer patients), cardiology (chronic heart failure), patient blood management and women’s health are ongoing.
1. PREFER study results presented at the German Society of Internal Medicine (DGIM) Congress, Wiesbaden, 16 April 2012.
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