Simultaneously, results were published in the peer-reviewed medical journal The
The study demonstrated there were significantly fewer hospital readmissions due to HF among patients treated with Ferinject compared to placebo. After 52 weeks, patients who received iron supplementation were 26% less likely to be re-admitted to the hospital for HF compared to placebo, after only one or two injections [RR 0.74; 95% CI 0.58-0.94; p=0.013].
'This is the first study demonstrating the benefits of iron supplementation initiated in stabilized patients hospitalized for AHF,' said Prof
'We are delighted to have presented full data from the AFFIRM-AHF study at the American Heart Association Scientific Sessions congress. This important data strengthens the evidence previously generated in large studies such as FAIR-HF and CONFIRM-HF,' said Dr
On
The outbreak of the COVID-19 pandemic resulted in significant disruption to the healthcare systems, with a 40% reduction in HF hospitalizations in
Additional significant results were seen with several secondary outcomes, including treatment benefits with Ferinject observed seen on the time to first HF hospitalization or CV death (p=0.030) and days lost due to HF hospitalizations and CV death (p=0.035). These effects were more pronounced in the pre-COVID-19 analyses.
AFFIRM-AHF is the first of three ongoing mortality and morbidity trials including FAIR-HF2 and HEART-FID to understand the full potential of Ferinject for those suffering from heart failure and iron deficiency. The study was a randomized, double-blind placebo-controlled trial with 1,108 patients in 15 countries, designed to evaluate the effect of Ferinject or placebo administered prior to and subsequent to discharge in patients after AHF and iron deficiency on recurrent HF hospitalizations and CV death at 52 weeks after randomization.
Iron deficiency is present in approximately 80% of patients after AHF and indicates poor prognosis. It is associated with poor quality of life and increased risk for hospitalization and mortality, regardless of the presence or absence of anemia. Hospitalization due to AHF represents a growing health care problem that is associated with a higher risk of adverse clinical outcomes and huge economic burden.
Contact:
Nathalie Ponnier
Tel: +41 79 957 96 73
Email: media@viforpharma.com
About AFFIRM-AHF
The AFFIRM-AHF study is a multi-centre, randomised, double-blind, placebo-controlled trial, comparing the effect of Intravenous Ferric Carboxymaltose (FCM) on hospitalizations and mortality in iron deficient patients admitted for Acute Heart Failure (AHF). AFFIRM-AHF is the first study that evaluates the benefit of Ferinject on hospitalizations and mortality in a very high risk population with iron deficiency and admitted in hospital for an episode of acute heart failure.
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