Ferric Carboxymaltose in Heart Failure with Iron Deficiency.

Abstract

BACKGROUND:

Ferric carboxymaltose therapy reduces symptoms and improves quality of life in patients who have heart failure with a reduced ejection fraction and iron deficiency. Additional evidence about the effects of ferric carboxymaltose on clinical events is needed.

METHODS:

In this double-blind, randomized trial, we assigned ambulatory patients with heart failure, a left ventricular ejection fraction of 40% or less, and iron deficiency, in a 1:1 ratio, to receive intravenous ferric carboxymaltose or placebo, in addition to standard therapy for heart failure. Ferric carboxymaltose or placebo was given every 6 months as needed on the basis of iron indexes and hemoglobin levels. The primary outcome was a hierarchical composite of death within 12 months after randomization, hospitalizations for heart failure within 12 months after randomization, or change from baseline to 6 months in the 6-minute walk distance. The significance level was set at 0.01.

RESULTS:

We enrolled 3065 patients, of whom 1532 were randomly assigned to the ferric carboxymaltose group and 1533 to the placebo group. Death by month 12 occurred in 131 patients (8.6%) in the ferric carboxymaltose group and 158 (10.3%) in the placebo group; a total of 297 and 332 hospitalizations for heart failure, respectively, occurred by month 12; and the mean (±SD) change from baseline to 6 months in the 6-minute walk distance was 8±60 and 4±59 m, respectively (Wilcoxon-Mann-Whitney P = 0.02; unmatched win ratio, 1.10; 99% confidence interval, 0.99 to 1.23). Repeated dosing of ferric carboxymaltose appeared to be safe with an acceptable adverse-event profile in the majority of patients. The number of patients with serious adverse events occurring during the treatment period was similar in the two groups (413 patients [27.0%] in the ferric carboxymaltose group and 401 [26.2%] in the placebo group).

CONCLUSIONS:

Among ambulatory patients who had heart failure with a reduced ejection fraction and iron deficiency, there was no apparent difference between ferric carboxymaltose and placebo with respect to the hierarchical composite of death, hospitalizations for heart failure, or 6-minute walk distance. (Funded by American Regent, a Daiichi Sankyo Group company; HEART-FID ClinicalTrials.gov number, NCT03037931.).

• Authors: Robert J Mentz, 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, Adrian F Hernandez, HEART-FID Investigators
• Journal: The New England journal of medicine (N Engl J Med) Vol. 389 Issue 11 Pg. 975-986 (Sep 14 2023) ISSN: 1533-4406 [Electronic] United States
• PMID: 37632463 (Publication Type: Randomized Controlled Trial, Journal Article)
• Copyright: Copyright © 2023 Massachusetts Medical Society.

Chemical References

• ferric carboxymaltose
• Ferric Compounds

Topics

• Humans
• Heart Failure (complications, drug therapy, physiopathology)
• Iron Deficiencies (complications, drug therapy)
• Quality of Life
• Stroke Volume
• Ventricular Function, Left
• Ferric Compounds (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Administration, Intravenous
• Ambulatory Care