EFFECT-HF demonstrates a significantly beneficial effect of Ferinject® on exercise capacity among patients with chronic heart failure and iron deficiency
- The EFFECT-HF study evaluated the impact of intravenous Ferinject® (ferric carboxymaltose) therapy versus standard of care on exercise capacity in symptomatic patients with chronic heart failure and iron deficiency.
- The study met its primary endpoint demonstrating a statistically significant difference in peak oxygen uptake (VO2) between treatment groups after 24 weeks, irrespective of anaemia status.
- These results confirm and extend upon the findings of previous clinical studies showing that treatment with Ferinject® has a beneficial effect on exercise capacity and symptoms in patients with heart failure and iron deficiency.
EFFECT-HF was a multicentre, randomised, controlled, open-label study conducted in symptomatic patients with stable heart failure and iron deficiency1. A total of 174 patients from nine countries were randomized to receive either Ferinject® or standard of care for 24 weeks was associated with significant improvements in New York Heart Association (NYHA) functional class and self-reported Patient Global Assessment (PGA) compared with standard of care.
The results of the EFFECT-HF study were presented at the American Heart Association’s Scientific Sessions 2016 in New Orleans in November. Principal investigator, Professor Dirk van Veldhuisen, University of Groningen, The Netherlands, who presented the findings stated: “Iron deficiency is present in approximately 50% of patients with chronic heart failure2, and has been associated with impaired exercise capacity3, poor quality of life4 and increased mortality2. The EFFECT-HF study clearly demonstrates that treatment with ferric carboxymaltose provided a significantly beneficial effect on peak VO2 compared with the control group. These results are in contrast to the findings in the IRONOUT5 study, also presented in the same session at AHA, which showed no effect of oral iron treatment on peak VO2.”
The EFFECT-HF study results confirm and extend upon the findings of the FAIR-HF6 and CONFIRM-HF7 studies, which also demonstrated that treatment with Ferinject® was associated with improvements in functional capacity and symptoms, in patients with chronic heart failure and iron deficiency. Building upon this body of evidence, AFFIRM-HF, a new study designed to compare the efficacy and safety of iron therapy with Ferinject® (ferric carboxymaltose) against placebo in patients with acute heart failure and iron deficiency, will begin enrolment shortly.
Overall, the data from EFFECT-HF further reinforce the position of Ferinject® as an effective treatment option for the correction of iron deficiency in chronic heart failure. The 2016 European Society of Cardiology (ESC) Guidelines for the diagnosis and treatment of acute and chronic heart failure, which were released in May this year, recommend that Ferinject® should be considered for the treatment of all symptomatic patients with systolic heart failure and iron deficiency in order to alleviate heart failure symptoms, improve exercise capacity and quality of life8. These recommendations were based on the findings of the FAIR-HF6 and CONFIRM-HF7 studies.
- Van Veldhuisen DJ, Ponikowski P, Metra M, et al. Effect of ferric carboxymaltose on exercise capacity in patients with iron deficiency and chronic heart failure (EFFECT-HF): A randomized controlled study. American Heart Association 2016 Scientific Sessions; November 16, 2016; New Orleans.
- 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.
- Lewis GD, McNulty S, Hernandez AF, et al. Oral iron repletion effects on oxygen uptake in heart failure (IRONOUT HF). American Heart Association 2016 Scientific Sessions; November 16, 2016; New Orleans.
- 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. Eur Heart J 2015;36:657–668.
- Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur J Heart Fail. 2016;18:891–975.