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Intravenous Iron Treatment Provides Some Benefit to Patients with Heart Failure and Iron Deficiency

Despite numerical improvements in mortality, hospitalizations, and exercise ability, data did not reach the pre-specified level of statistical significance


Stephanie Lopez
Stephanie Lopez
919-724-5934 Email

DURHAM, N.C. – More than half of all patients with heart failure experience iron deficiency, which is associated with worse symptoms, poor quality of life, and diminished exercise ability.

A new study led by Duke Health researchers with global collaborators finds an intravenous iron treatment provides a measure of benefit to these patients, but the results are nuanced.

The study is published in the New England Journal of Medicine and presented at the European Society of Cardiology Congress on Aug. 26. It evaluated the intravenous drug, ferric carboxymaltose, by looking at data on mortality, heart failure hospitalizations, and exercise capacity from more than 3,000 global study participants over a minimum follow-up period of 12 months.

While the results didn’t meet the study’s higher threshold for statistical significance, the therapy demonstrated a numerical improvement across mortality, heart failure hospitalizations, and exercise capacity. The research team also noted results from a pre-specified pooled analysis with two previous studies of ferric carboxymaltose in heart failure, all comparing the drug to placebo for a fuller look at the available data.

“In the broader review using all three studies, we saw a 14% reduction in cardiovascular deaths and total cardiovascular hospitalizations and a 12% reduction in cardiovascular death or heart failure hospitalization events overall across data from more than 4,500 participants collectively,” said Robert Mentz, M.D., corresponding author of the study, associate professor in the Department of Medicine at Duke University School of Medicine, and member of the Duke Clinical Research Institute

“As a practicing heart failure cardiologist, I have felt comfortable prescribing intravenous iron for patients with heart failure prior to this study given the known benefits on improvement in quality of life and exercise capacity,” Mentz said. “Now that we have these results, we have important additional data that show this therapy has potential benefits on clinical outcomes, which could help a broad group of patients with heart failure and iron deficiency across the globe.”

The study was funded by American Regent, Inc., which manufactures ferric carboxymaltose, and is part of the Daiichi Sankyo Group.

In addition to Mentz, study authors include Jyotsna Garg, Frank W. Rockhold, Javed Butler, Carmine G. De Pasquale, Justin A. Ezekowitz, Gregory D. Lewis, Eileen O’Meara, Piotr Ponikowski, Richard W. Troughton, Yee Weng Wong, Lilin She, Josephine Harrington, Robert Adamczyk, Nicole Blackman, and Adrian F. Hernandez.

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