Health Status Improvement with Ferric Carboxymaltose in Heart Failure with Reduced Ejection Fraction and Iron Deficiency

Department of Medicine, University of Mississippi, Jackson, MS, USA. Division of Cardiology, Duke University Medical Center, Durham, NC, USA. Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany. DZHK (German Center for Cardiovascular Research), partner site Göttingen, Göttingen, Germany. Wroclaw Medical University, Wroclaw, Poland. Vifor Pharma Ltd., Glattbrugg, Switzerland. Department of Cardiology, University and Civil Hospital, Brescia, Italy. Central Michigan University, Mount Pleasant, Michigan. University of Warwick, Coventry, UK. Centre for Clinical and Basic Research, Department of Medical Sciences, IRCCS San Raffaele Pisana, Rome, Italy. Department of Cardiology, Bellvitge University Hospital, Barcelona, Spain. IDIBELL (Institute of Biomedical Investigation of Bellvitge), University of Barcelona, Hospitalet de Llobregat, Barcelona, Spain. Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. National and Kapodistrian University of Athens, Athens University Hospital Attikon, Athens, Greece. Department of Cardiology (CVK); and Berlin Institute of Health Center for Regenerative Therapies (BCRT). DZHK (German Center for Cardiovascular Research) Berlin partner site, Charité Universitätsmedizin Berlin, Germany.

European journal of heart failure. 2022
AIM: Intravenous ferric carboxymaltose (FCM) has been shown to improve overall quality of life in iron-deficient heart failure with reduced ejection fraction (HFrEF) patients at a trial population level. This FAIR-HF and CONFIRM-HF pooled analysis explored the likelihood of individual improvement or deterioration in Kansas City Cardiomyopathy Questionnaire (KCCQ) domains with FCM vs placebo and evaluated the stability of this response over time. METHODS Changes vs baseline in KCCQ overall summary score (OSS), clinical summary score (CSS) and total symptom score (TSS) were assessed at weeks 12 and 24 in FCM and placebo groups . Mean between-group differences were estimated and individual responder analyses and analyses of response stability were performed. RESULTS Overall, 760 (FCM: 454) patients were studied. At week 12, the mean improvement in KCCQ OSS was 10.6 points with FCM vs 4.8 points with placebo (least-square mean difference [95% confidence interval (CI)]: 4.36 [2.14;6.59] points). A higher proportion of patients on FCM vs placebo experienced a KCCQ OSS improvement of ≥5 (58.3% vs 43.5%; odds ratio [95% CI]: 1.81 [1.30;2.51]), ≥10 (42.4% vs 29.3%; 1.73 [1.23;2.43]) or ≥15 (32.1% vs 22.6%; 1.46 [1.02;2.11]) points. Differences were similar at week 24 and for CSS and TSS domains. Of FCM patients with a ≥5-, ≥10- or ≥15-point improvement in KCCQ OSS at week 12, >75% sustained this improvement at week 24. CONCLUSION Treatment of iron-deficient HFrEF patients with intravenous FCM conveyed clinically relevant improvements in health status at an individual-patient level; benefits were sustained over time in most patients. This article is protected by copyright. All rights reserved.
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Language : eng
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