Intravenous (IV) ferric carboxymaltose (FCM) led to significantly greater improvement in health-related quality of life over 24 weeks compared with placebo in iron-deficient stabilized patients with heart failure (HF) and left ventricular ejection fraction (LEVF) ≤50%, according to study findings in the European Heart Journal.
This analysis of the AFFIRM-AHF study included 1058 patients with HF and an LEVF ≤50% who had stabilized following an acute HF episode. Patients were randomly assigned to either intravenous FCM (n=535) or placebo (n=523).
Total FCM doses were calculated based on hemoglobin and body weight at baseline. The repletion dose of FCM was given to patients at discharge and at week 6. Patients received up to 1000 mg FCM or placebo at the first and second dosing periods. In cases of persisting iron deficiency, patients then received additional FCM doses of 500 mg at weeks 12 and 24.
Patients completed the baseline 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12) before randomization as well as at weeks 2, 4, 6, 12, 24, 36, and 52. The mean KCCQ-12 overall summary scores (OSS) at baseline were similar between the FCM and placebo groups (mean ± SE, 38.7±0.9 vs 37.1±0.8, respectively). The corresponding values for the clinical summary score (CSS) were also similar between the 2 arms (40.9±0.9 vs 40.1±0.9).
At week 4, the FCM group began to experience significantly greater improvements in OSS (adjusted mean difference [aMD], 2.9; 95% CI, 0.5-5.3; P =.018) and CSS scores (aMD, 2.8; 95% CI, 0.3-5.3; P =.029) compared with the placebo group. The FCM arms continued to experience significantly better scores at week 24 (OSS: aMD, 3.0; 95% CI, 0.3-5.6; P =.028; CSS: aMD, 2.9; 95% CI, 0.2-5.6; P =.035). The treatment effect attenuated by 1 year but continued to favor FCM.
Based on the way the data were analyzed, the investigators concluded “the changes in quality of life reported in this paper are independent of any direct influence of recent HF hospitalizations that patients could experience.”
Disclosure: This clinical trial was supported by Vifor Pharma. Some study authors declared affiliations with the biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Jankowska EA, Kirwan BA, Kosiborod M, et al. The effect of intravenous ferric carboxymaltose on health-related quality of life in iron-deficient patients with acute heart failure: the results of the AFFIRM-AHF study. Published online June 3, 2021. Eur Heart J. doi:10.1093/eurheartj/ehab234