GLATTBRUGG, Switzerland, Aug. 31, 2015 (GLOBE NEWSWIRE) -- This meta-analysis, presented at ESC Congress 2015, was performed using the four available completed double-blind trials conducted in ambulatory patients with systolic chronic heart failure (CHF) and iron deficiency (ID) which compared the efficacy and safety of intravenous (i.v.) iron therapy with Ferinject® (ferric carboxymaltose) against placebo. These four studies, including the FAIR-HF and CONFIRM-HF studies, previously demonstrated that Ferinject® improved exercise capacity, symptoms and quality of life in patients with CHF and ID. Although a lower occurrence for hospitalisation and death was noted in these studies, they were not powered to show differences in hospitalisations and mortality between Ferinject® and placebo. This meta-analysis now demonstrates that treatment with Ferinject® was associated with a significant 41% reduction in the risk of recurrent cardiovascular (CV) hospitalisation or CV death [rate ratio (95% CI): 0.59 (0.40-0.88), p=0.009].
"This analysis shows that treating iron deficiency in patients with systolic chronic heart failure with ferric carboxymaltose could have a significant impact on cardiovascular outcomes," says Stefan Anker, lead author of the meta-analysis and past-President of the Heart Failure Association of the ESC. "Iron deficiency is a common comorbidity in heart failure and it is a significant burden for patients, despite use of optimal conventional heart failure therapy. Whereas these findings with Ferinject® should be confirmed by a large clinical trial, the diagnosis and treatment of iron deficiency to improve exercise capacity, symptoms and quality of life remains an integral part of an optimised CHF care approach."
By analysing pooled individual data from the four completed double-blind trials conducted in ambulatory patients with systolic CHF and ID (FER-CARS-01, FAIR-HF1, EFFICACY-HF and CONFIRM-HF2), this meta-analysis represents a robust analysis of the potential effects of Ferinject® on hospitalisation and mortality outcomes in this patient population. For all four studies, hospitalisations and cause of death were independently adjudicated in a blinded manner by an adjudication committee using the same pre-defined criteria. All trials were designed as double-blind, multi-centre, prospective, randomised trials and enrolled ambulatory patients with symptomatic CHF (NYHA class II/III) with LVEF < 45% and with presence of ID (defined as ferritin <100 ng/mL, or ferritin 100-299 ng/mL if transferrin saturation (TSAT) <20%). Overall, 839 patients were eligible for this meta-analysis, treated in 138 centres across 19 countries. The Ferinject® and placebo groups consisted of 504 and 335 patients, respectively.
Iron deficiency is a recognised comorbidity in CHF3 and, in Europe, may be present in up to 50% of patients with CHF4. Many studies have described ID, with or without anaemia, as an independent risk-factor for mortality4, poor exercise capacity5 and low quality of life6.
Detailed results of the study are being disclosed at ESC Congress 2015 taking place in London, UK, from August 29th to September 2nd, 2015.
For further information, please contact:
Media Relations:
Beatrix Benz, Head of Global Communications
Tel.: +41 58 851 80 16
E-mail: media@viforpharma.com
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.
For more information about Vifor Pharma and its parent company Galenica, please visit www.viforpharma.com and www.galenica.com .
Ferinject® ( US brand name: Injectafer®) is an innovative non-dextran intravenous (i.v.) iron 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 68 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 diseases. 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.
References
- Anker SD, Comin-Colet J, Filippatos G, et al. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med 2009; 361:2436-2448.
- Ponikowski P, van Veldhuisen DJ, Comin-Colet J, et al. Beneficial effects of long term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiency. European Heart Journal 2015;36:657-668.
- McMurray JJ, Adamopoulos S, Anker SD, et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012. Eur Heart J 2012; 33, 1787-1847.
- Klip IT, Comin-Colet J, Voors AA, Ponikowski P, et al. Iron deficiency in chronic heart failure: an international pooled analysis. Am Heart J 2013; 165:575-582.
- Jankowska EA, Rozentryt P, Witkowska A, et al. Iron deficiency predicts impaired exercise capacity in patients with systolic chronic heart failure. J Cardiac Fail 2011; 17:899-906.
- Enjuanes C, Klip IT, Bruguera J, et al. Iron deficiency and health-related quality of life in chronic heart failure: Results from a multicenter European study. Int J Cardiol 2014; 174:268-275.
Press Release (PDF) http://hugin.info/148637/R/1948636/707900.pdf
Media Backgrounder (PDF) http://hugin.info/148637/R/1948636/707901.pdf
HUG#1948636