Ferric carboxymaltose results in improved QoL in iron-deficient patients, stabilized after acute HF
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
Introduction and methods
Iron deficiency has a negative impact on symptom burden, exercise capacity and quality of life in patients with HF [1-3]. The AFFIRM-AHF trial previously showed that intravenous (IV) ferric carboxymaltose (FCM) reduced the risk of recurrent HF hospitalizations in iron-deficient patients who had stabilized after acute HF . This analysis evaluated the effect of IV FCM vs. placebo on the quality of life in the AFFIRM-AHF population.
AFFIRM-AHF trial was a randomized, double-blind, placebo- controlled trial that enrolled hospitalized patients (aged ≥18 years) with acute HF. Eligible patients were iron-deficient (serum ferritin <100 ng/mL, or 100-299 ng/mL with transferrin saturation <20%), had received at least 40 mg of IV furosemide (or equivalent) and had an LVEF <50% within 12 months prior to randomization. Patients were randomized to receive IV FCM (n=535) or placebo (n=523). A repletion dose of up to 1000 mg FCM or placebo was administered at discharge and Week 6. If iron deficiency persisted, additional doses of 500 mg FMC or placebo were administered at weeks 12 and 24. Health-related quality of life (HRQoL) was evaluated using the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12). The KCCQ-12 was completed by participants at baseline (just prior to randomization) and at weeks 2, 4, 6, 12, 24, 36, and 52. The KCCQ-12 overall summary score (OSS) includes pooled information on symptoms, physical and social functioning and perception of quality of life. The KCCQ-12 clinical summary score (CSS) includes pooled information on symptoms, and physical and social functioning. A lower score represents relatively more severe symptoms, limitations and/or lower quality of live.
- At baseline, KCCQ-12 OSS and CSS were similar and impaired in both treatment groups. The KCCQ-12 OSS were 38.1± 0.9 points and 37.1± 0.8 points in the FCM and placebo groups, respectively. The KCCQ-12 CSS were 40.9± 0.9 points and 40.1± 0.9 points, respectively.
- At week 2, changes in OCC and CSS scores were similar in the FCM group and placebo group.
- At weeks 4 and 24, patients in the FCM group had significantly greater improvements in OCC and CSS compared to those in the placebo group (Adjusted mean difference at week 4: 2.9, 95%CI 0.5-5.3, P=0.018 for OSS and 2.8, 95%CI 0.3-5.3, P=0.029 for CSS; Adjusted mean difference at week 24: 3.0, 95%CI 0.3-5.6, P=0.028 for OSS and 2.9, 95%CI 0.2-5.6, P=0.035 for CSS).
- At Week 52, the treatment effect had lessened and there was no significant difference in OCC and CSS scores between treatment groups.
This pre-specified analysis of the AFFIRM-AHF trial showed that treatment with IV FCM after hospitalization for acute HF in iron-deficient patients led to significantly greater improvements in health-related quality of life (measured with KCCQ-12 OSS and CSS) from Week 4 to Week 24 after discharge, compared to placebo. The treatment benefit attenuated at Week 52.