CONFIRM-HF study demonstrates that Injectafer(r) (Ferinject(r)) improves exercise capacity in patients with chronic heart failure

| Source: Vifor Pharma Ltd. Vifor Pharma Ltd.

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:

Media Relations:
Beatrix Benz, Head of Global Communications
E-mail: communications@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 .

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.

References

  1. McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Böhm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Køber L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Rønnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012. Eur Heart J 2012; 33, 1787-1847.
  2. Klip IT , Comin-Colet J , Voors AA , Ponikowski P , Enjuanes C , Banasiak W , Lok DJ , Rosentryt P , Torrens A , Polonski L , van Veldhuisen DJ , van der Meer P , Jankowska EA . Iron deficiency in chronic heart failure: an international pooled analysis. Am Heart J 2013; 165:575-582.
  3. Jankowska EA , Rozentryt P , Witkowska A , Nowak J , Hartmann O , Ponikowska B , Borodulin-Nadzieja L , von Haehling S , Doehner W , Banasiak W , Polonski L , Filippatos G , Anker SD , Ponikowski P . Iron deficiency predicts impaired exercise capacity in patients with systolic chronic heart failure. J Cardiac Fail 2011; 17:899-906.
  4. Enjuanes C , Klip IT , Bruguera J , Cladellas M , Ponikowski P , Banasiak W , van Veldhuisen DJ , van der Meer P , Jankowska EA , Comín-Colet J . 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.
  5. Toblli JE, Lombrana A, Duarte P, Di Gennaro F. Intravenous iron reduces NT-pro-brain natriuretic peptide in anemic patients with chronic heart failure and renal insufficiency. J Am Coll Cardiol 2007;50:1657-1665.
  6. Bolger AP, Bartlett FR, Penston HS, O'Leary J, Pollock N, Kaprielian R, Chapman CM. Intravenous iron alone for the treatment of anemia in patients with chronic heart failure. J Am Coll Cardiol 2006;48:1225-1227.
  7. Okonko DO, Grzeslo A, Witkowski T, Mandal AK, Slater RM, Roughton M, Foldes G, Thum T, Majda J, Banasiak W, Missouris CG, Poole-Wilson PA, Anker SD, Ponikowski P. Effect of intravenous iron sucrose on exercise tolerance in anemic and nonanemic patients with symptomatic chronic heart failure and iron deficiency FERRIC-HF: a randomized, controlled, observer blinded trial. J Am Coll Cardiol 2008;51:103-112.
  8. Usmanov RI, Zueva EB, Silverberg DS, Shaked M. Intravenous iron without erythropoietin for the treatment of iron deficiency anemia in patients with moderate to severe congestive heart failure and chronic kidney insufficiency. J Nephrol 2008;21:236-242.
  9. Anker SD, Comin Colet J , Filippatos G , Willenheimer R , Dickstein K , Drexler H , Lüscher TF , Bart B , Banasiak W , Niegowska J , Kirwan BA , Mori C , von Eisenhart Rothe B , Pocock SJ , Poole-Wilson PA , Ponikowski P ; FAIR-HF Trial Investigators . Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med 2009; 361:2436-2448.

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