Glattbrugg, Switzerland, Sept. 2, 2014 (GLOBE NEWSWIRE) -- The CONFIRM-HF study was designed to compare the efficacy and safety of iron therapy with Injectafer® (US brand name of Ferinject®, ferric carboxymaltose) against placebo in patients with chronic heart failure (CHF) and iron deficiency over one year. The study met its primary endpoint, significant improvement in 6 minute walk test (6MWT) from baseline to week 24 - and also confirmed and complemented, the efficacy and safety profile of Ferric Carboxymaltose observed in the FAIR-HF study*.
CONFIRM-HF is the longest study conducted in patients with CHF and iron deficiency (ID) to assess the long-term clinical benefits of Injectafer® (Ferinject®) beyond iron repletion and anaemia correction. More than 300 patients from 9 countries were included in this 52 weeks clinical trial. While the primary endpoint - significant improvement in 6MWT at 24 weeks - was achieved, the results also showed that the improvement was maintained over the duration of the study. Other secondary measures of efficacy, patient's functional status (NYHA class) and quality of life, also showed favourable results. Rates of hospitalization for worsening heart failure were also significantly lower in the Injectafer® group. Patients in the Injectafer® group received a median total dose of 1,500mg iron during the one year study period (with a dosing range of 500 to 3,500mg iron) to correct ID and maintain the iron parameters within the normal range. CONFIRM-HF provides supportive, long-term evidence for effective and safe dosing of Injectafer® up to 1,000mg of iron as single intravenous (i.v.) bolus injection.
Iron deficiency is a recognized comorbidity in CHF1 and, in Europe, it is present in up to 50% of patients with CHF. Many studies have described ID, with or without anaemia, as a risk-factor for mortality2, poor exercise capacity3 and low quality of life4. These poor outcomes are associated with symptom burden and the ability of patients to conduct their activities of daily living. Therefore, ID represents a modifiable risk factor where therapeutic intervention could provide benefit to patients. Several studies, including the FAIR-HF study, have provided evidence for the advantages of i.v. iron therapy in CHF5-9, but the long term effects were not examined before CONFIRM-HF. The results from CONFIRM-HF advances our understanding on how to appropriately treat ID in patients with CHF.
Detailed results of the study are being disclosed at the European Society of Cardiology (ESC) taking place in Barcelona, Spain, from August 30th to September 3rd, 2014. In addition, the publication has been published online by the European Heart Journal. http://eurheartj.oxfordjournals.org/lookup/doi/10.1093/eurheartj/ehu385
*FAIR-HF is a large, multi-centre, randomised, double-blind, placebo-controlled, phase III study of patients with CHF and iron deficiency. It was designed to test the potential benefits of correcting iron deficiency with Ferinject® in symptomatic CHF patients regardless of whether they had anaemia or not. FAIR-HF met both of its primary endpoints: improvements in quality of life (measured using the self-reported Patient Global Assessment [PGA]) and CHF symptoms (defined by the New York Heart Association (NYHA) class) at week 24 compared with placebo. Both endpoints were statistically highly significant in favour of Ferinject®. The results were published in the New England Journal of Medicine in November 2009.
For further information, please contact:
Beatrix Benz, Head of Global Communications
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.
Injectafer ® ( US brand name of Ferinject®) 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 Injectafer®. To date, Ferinject® has gained marketing authorisation in 62 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.
CONFIRM-HF (Ferric CarboxymaltOse evaluatioN on perFormance in patients with IRon deficiency in coMbination with chronic Heart Failure) is a large prospective, randomized, double-blind, placebo-controlled study designed to investigate the efficacy and safety of intravenous (i.v.) Injectafer ® /Ferinject ® (ferric carboxymaltose) in patients with chronic heart failure (CHF) and iron deficiency (ID). The study was conducted in 41 sites across 9 countries.
304 stable ambulatory symptomatic patients with chronic heart failure and iron deficiency were randomized 1:1 to treatment with i.v. Injectafer ®/Ferinject® (n=152 ) or placebo (saline, n=152) for 52 weeks. The primary endpoint was a change in the 6-minute-walk-test (6MWT) distance from baseline to Week 24. Main secondary endpoints included changes in New York Heart Association (NYHA) class, Patient Global Assessment (PGA), health-related quality of life (QoL)and Fatigue Score. Rates of hospitalization and death were also pre-specified secondary endpoints.
Press Release (PDF) http://hugin.info/148637/R/1853027/647834.pdf