EFFECT-HF was a multicentre, randomised, controlled, open-label study conducted in symptomatic patients with stable heart failure and iron deficiency.1 A total of 174 patients from nine countries were randomised to receive either Ferinject® or standard of care for 24 weeks.
The study achieved its primary endpoint, demonstrating a statistically significant benefit with Ferinject® versus standard of care for the change in peak VO2 after 24 weeks of treatment. Analysis of secondary efficacy outcomes also found that Ferinject® 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 failure,2 and has been associated with impaired exercise capacity,3 poor quality of life4 and increased mortality.2 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 life.8 These recommendations were based on the findings of the FAIR-HF6 and CONFIRM-HF7 studies.