Monday, 11 July 2011, ↓ directly to download
Vifor Pharma has reached another important milestone in its clinical development program. The results of the FERRIM study have demonstrated that Venofer® – an intravenous iron product used to treat iron deficiency – improves fatigue and is well tolerated in non-anemic patients with low serum ferritin concentrations. These are the first results providing evidence that intravenous supplementation of iron can improve fatigue in iron deficient, non-anemic premenopausal women. These important results have been recently published in the prestigious peer-reviewed medical journal ‘Blood’.
Fatigue is common in the general practice with a prevalence rate up to one third of the population.1-5 Similarly, iron deficiency is a frequently occurring disorder that can cause fatigue, as suggested by different clinical studies.6-8 FERRIM is the first study investigating the efficacy and safety of intravenous iron in treating fatigue in non-anemic women with iron deficiency.
The primary objective of the FERRIM study was to determine the efficacy of intravenous iron compared with placebo in decreasing fatigue 6 weeks after treatment initiation in non-anemic patients with iron deficiency (serum ferritin ≤50 ng/ml). Fatigue was assessed using the Brief Fatigue Inventory (BFI; severity of fatigue) and the Short Performance Inventory (SPI; improvement in fatigue) questionnaires. Patients were followed-up for 12 weeks.
Dr. Pierre-Alexandre Krayenbühl, Division of Internal Medicine, University Hospital of Zurich, Zurich, Switzerland, and first author comments: “Our study is the first study analyzing the impact of intravenous iron on fatigue symptoms in patients with low serum ferritin. We could show that refilling depleted body iron stores with intravenous iron sucrose improved fatigue in non-anemic patients.”
Patients in the intravenous iron group reported improvement in fatigue (65% and 63% of patients after 6 and 12 weeks, respectively) significantly more often than in the placebo group (40% and 34% of patients after 6 and 12 weeks, p=0.02 and 0.006, respectively) as evaluated by the SPI. The assessment of fatigue with the BFI score showed a non-significant but positive trend for a greater decrease of fatigue following intravenous iron (decrease of 1.1 and 1.3 points after 6 and 12 weeks, respectively) than following placebo (decrease of 0.7 and 0.9 points after 6 and 12 weeks, respectively).
Looking at subgroups, fatigue significantly improved according to both scores in patients with a baseline serum ferritin ≤15 ng/ml or a serum ferritin ≤50 ng/ml with a transferrin saturation ≤20%. Among patients with serum ferritin ≤15 ng/ml, 82% reported improvement in fatigue (after both 6 and 12 weeks) in the iron-treated group compared with 47% and 35% (after 6 and 12 weeks respectively) in the placebo group, as assessed by SPI. The median BFI score decreased by 1.8 points in the iron group compared with 0.4 points in the placebo group after 6 weeks and by 2.3 points versus 0.7 points after 12 weeks. Similar results were obtained in patients with a serum ferritin ≤50 ng/ml and a transferrin saturation ≤20%.
Moreover, only iron-treated patients successfully replenished the body iron stores (serum ferritin of 98 ng/ml versus 1 ng/ml for placebo after treatment). Intravenous administration of iron sucrose was well tolerated. A study with iron carboxymaltose (Ferinject®, PREFER study) has been designed using the results of this initial study which confirmed the appropriate patient groups. This study is ongoing with a larger number of patients, and aims to confirm these positive results.
The FERRIM online publication is available on the internet site of Blood under the following link: http://bloodjournal.hematologylibrary.org/
About FERRIM Study
The FERRIM trial was a randomized, multi-centre, double-blind, placebo-controlled, phase III study of non-anemic patients with fatigue and iron deficiency. It is the first study that was designed to investigate whether correction of iron deficiency using intravenous iron (Venofer®, iron sucrose) confers a benefit in patients with fatigue and iron deficiency. Ninety premenopausal women presenting fatigue, serum ferritin ≤50 ng/ml and Hb ≥120 g/l were randomized (1:1) to receive either 800 mg (4 x 200 mg) intravenous iron (III)-hydroxide sucrose or intravenous placebo (0.9% NaCl). Treatment was delivered on 4 days during the first two weeks of the study. Fatigue and serum iron status were assessed at baseline, after 6 and 12 weeks using the BFI score (severity of fatigue; median fatigue at baseline was 4.5 as assessed on a scale from 0 to 10; 0=no fatigue, 10 maximal imaginable fatigue) and SPI (to categorise fatigue: slightly better, much better or completely resolved) questionnaires.
Venofer® is an intravenous iron replacement product from Vifor Pharma. Today Venofer® has market authorization in over 80 countries for the treatment of iron deficiency where oral iron is ineffective or cannot be used. Venofer®, the originator iron sucrose, is not associated with dextran induced hypersensitivity reactions and has a low potential for iron toxicity as demonstrated in studies on pharmacovigilance data. In many countries, intravenous iron replacement products are primarily used to treat dialysis patients.
1. Bates DW, Schmitt W, Buchwald D et al. Prevalence of fatigue and chronic fatigue syndrome in a primary care practice. Arch Intern Med. 1993; 153(24): 2759-65.
2. Cathebras PJ, Robbins JM, Kirmayer LJ, Hayton BC. Fatigue in primary care: prevalence, psychiatric comorbidity, illness behavior, and outcome. J Gen Intern Med. 1992; 7(3): 276-86.
3. Fuhrer R, Wessely S. The epidemiology of fatigue and depression: a French primary-care study. Psychol Med. 1995; 25(5): 895-905.
4. Kroenke K, Arrington ME, Mangelsdorff AD. The prevalence of symptoms in medical outpatients and the adequacy of therapy. Arch Intern Med. 1990; 150(8): 1685-9.
5. Pawlikowska T, Chalder T, Hirsch SR et al. Population based study of fatigue and psychological distress. BMJ. 1994; 308(6931): 763-6.
6. Beutler E, Larsh S, Gurney C. Iron therapy in chronically fatigued, nonanemic women: a double-blind study. Ann Intern Med. 1960; 52: 378-94.
7. Patterson AJ, Brown WJ, Roberts DC. Dietary and supplement treatment of iron deficiency results in improvements in general health and fatigue in Australian women of childbearing age. J Am Coll Nutr. 2001; 20(4): 337-42.
8. Verdon F, Burnand B, Stubi CL et al. Iron supplementation for unexplained fatigue in non-anaemic women: double blind randomised placebo controlled trial. BMJ. 2003; 326(7399): 1124-6.
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.
Friday, 7 October 2011
Wednesday, 17 August 2011
Wednesday, 13 July 2011