Study did not meet primary endpoint for composite of death, heart failure hospitalization, and exercise function
By Lori Solomon HealthDay Reporter
TUESDAY, Aug. 29, 2023 (HealthDay News) — Ferric carboxymaltose does not improve a hierarchical composite outcome of death, heart failure hospitalizations, and exercise function in ambulatory patients with heart failure with reduced ejection fraction and iron deficiency, according to a study published online Aug. 26 in the New England Journal of Medicine to coincide with the European Society of Cardiology Congress 2023, held from Aug. 25 to 28 in Amsterdam.
Robert J. Mentz, M.D., from Duke University in Durham, North Carolina, and colleagues randomly assigned (1:1) 3,065 ambulatory patients with heart failure, a left ventricular ejection fraction of ≤40 percent, and iron deficiency to receive intravenous ferric carboxymaltose or placebo every six months as needed, in addition to standard therapy for heart failure. The primary outcome was a hierarchical composite of three outcomes: death within 12 months after randomization, hospitalizations for heart failure within 12 months after randomization, or change from baseline to six months in the six-minute walk distance.
The researchers found that for the primary outcome, death by month 12 occurred in 8.6 percent of patients receiving ferric carboxymaltose versus 10.3 percent receiving placebo, the ferric carboxymaltose group had 297 hospitalizations for heart failure by month 12 versus 332 in the placebo group, and the mean change from baseline to six months in the six-minute walk distance was 8 m and 4 m, respectively. The difference between the ferric carboxymaltose and placebo groups did not meet the prespecified significance level of 0.01 required for regulatory success (P = 0.02; unmatched win ratio, 1.10; 99% confidence interval, 0.99 to 1.23) for the hierarchical composite of the three outcomes. For the majority of patients, repeated dosing of ferric carboxymaltose appeared to be safe with an acceptable adverse-event profile. A similar number of patients in each group had serious adverse events during the treatment period (27.0 percent in the ferric carboxymaltose group versus 26.2 percent in the placebo group).
“Future analyses — preferably a meta-analysis of individual-patient data from all intravenous iron trials — should assess the importance of the transferrin saturation value at baseline,†write Pieter Martens, M.D., Ph.D., and Wilfried Mullens, M.D., Ph.D., both from Hasselt University in Belgium, in an accompanying editorial. “This could help redefine the definition of iron deficiency in patients with heart failure and, we hope, help clinicians determine which patients might benefit from intravenous iron supplementation.â€
Mentz reports financial ties to the pharmaceutical industry, including American Regent, a Daiichi Sankyo Group company, which funded the study.
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