Treating iron deficiency in heart failure provides some benefits

Use of ferric carboxymaltose in patients who have heart failure with a reduced ejection fraction and iron deficiency appears to yield only numerical improvements the hierarchical composite of death, hospitalizations for heart failure, or 6-minute walk distance as compared with placebo, according to data from the HEART-FID trial.

HEART-FID included 3,065 patients with heart failure, a left ventricular ejection fraction of ≤40 percent, and iron deficiency. These patients were randomly assigned to receive either ferric carboxymaltose (n=1,532) or placebo (n=1,533) intravenously, in addition to standard therapy for heart failure. Ferric carboxymaltose or placebo was administered every 6 months as needed, depending on iron indexes and haemoglobin levels.

The primary outcome of the hierarchical composite of death or hospitalizations for heart failure within 12 months after randomization or change from baseline to 6 months in the 6-minute walk distance was better in the ferric carboxymaltose group than in the placebo group, although the difference was not statistically significant (unmatched win ratio, 1.10, 99 percent confidence interval, 0.99–1.23; p=0.02, with the significance level set at 0.01). 

In the ferric carboxymaltose and placebo groups, respectively, death occurred in 8.6 percent and 10.3 percent of patients, and a total of 297 and 332 hospitalizations for heart failure were documented by month 12. The corresponding 6-minute walk distance at 6 months increased by a mean of 8 and 4 m.

Repeated dosing of ferric carboxymaltose was relatively safe, with an acceptable adverse-event profile in the majority of patients. Serious adverse events occurring during the treatment period was recorded in 27.0 percent of patients in the ferric carboxymaltose group and in 26.2 percent of those in the placebo group.