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Efficacy of ferric carboxymaltose in heart failure with iron deficiency: an individual patient data meta-analysis.
Ponikowski, Piotr; Mentz, Robert J; Hernandez, Adrian F; Butler, Javed; Khan, Muhammad Shahzeb; van Veldhuisen, Dirk J; Roubert, Bernard; Blackman, Nicole; Friede, Tim; Jankowska, Ewa A; Anker, Stefan D.
Afiliación
  • Ponikowski P; Institute for Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.
  • Mentz RJ; Institute for Heart Diseases, University Hospital, Wroclaw, Poland.
  • Hernandez AF; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.
  • Butler J; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
  • Khan MS; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
  • van Veldhuisen DJ; Department of Medicine, Duke University, Durham, NC, USA.
  • Roubert B; Baylor Scott and White Research Institute, Dallas, TX, USA.
  • Blackman N; Department of Medicine, University of Mississippi, Jackson, MS, USA.
  • Friede T; Division of Cardiology, Duke University Medical Center, Durham, NC, USA.
  • Jankowska EA; Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
  • Anker SD; Research, Development, and Sciences, CSL Vifor, Glattbrugg, Switzerland.
Eur Heart J ; 44(48): 5077-5091, 2023 Dec 21.
Article en En | MEDLINE | ID: mdl-37632415
BACKGROUND AND AIMS: Whereas a beneficial effect of intravenous ferric carboxymaltose (FCM) on symptoms and exercise capacity among patients with iron deficiency and heart failure (HF) has been consistently demonstrated, the effects of treatment on clinical events remain the subject of research. This meta-analysis aimed to characterize the effects of FCM therapy on hospitalizations and mortality. METHODS: Patient-level data from randomized, placebo-controlled FCM trials including adults with HF and iron deficiency with ≥52 weeks follow-up were analysed. The co-primary efficacy endpoints were (i) composite of total/recurrent cardiovascular hospitalizations and cardiovascular death and (ii) composite of total HF hospitalizations and cardiovascular death, through 52 weeks. Key secondary endpoints included individual composite endpoint components. Event rates were analysed using a negative binomial model. Treatment-emergent adverse events were also examined. RESULTS: Three FCM trials with a total of 4501 patients were included. Ferric carboxymaltose was associated with a significantly reduced risk of co-primary endpoint 1 (rate ratio 0.86; 95% confidence interval 0.75-0.98; P = .029; Cochran Q: 0.008), with a trend towards a reduction of co-primary endpoint 2 (rate ratio 0.87; 95% confidence interval 0.75-1.01; P = .076; Cochran Q: 0.024). Treatment effects appeared to result from reduced hospitalization rates, not improved survival. Treatment appeared to have a good safety profile and was well tolerated. CONCLUSIONS: In iron-deficient patients with HF with reduced left ventricular ejection fraction, intravenous FCM was associated with significantly reduced risk of hospital admissions for HF and cardiovascular causes, with no apparent effect on mortality.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Anemia Ferropénica / Deficiencias de Hierro / Insuficiencia Cardíaca Tipo de estudio: Clinical_trials / Systematic_reviews Límite: Humans Idioma: En Revista: Eur Heart J Año: 2023 Tipo del documento: Article País de afiliación: Polonia Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Anemia Ferropénica / Deficiencias de Hierro / Insuficiencia Cardíaca Tipo de estudio: Clinical_trials / Systematic_reviews Límite: Humans Idioma: En Revista: Eur Heart J Año: 2023 Tipo del documento: Article País de afiliación: Polonia Pais de publicación: Reino Unido