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    Ferric carboxymaltose in patients with heart failure and iron deficiency

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    Authors
    Anker, Stefan D.
    Comin Colet, Josep
    Filippatos, Gerasimos S.
    Willenheimer, Ronnie
    Dickstein, Kenneth
    Drexler, Helmut
    Lüscher, Thomas F.
    Bart, Boris
    Banasiak, Waldemar
    Niegowska, Joanna
    Kirwan, Bridget-Anne
    Mori, Claudio
    von Eisenhart Rothe, Barbara
    Pocock, Stuart J.
    Poole-Wilson, Philip A.
    Ponikowski, Piotr
    Show allShow less
    Issue Date
    2009-12-17
    Subjects
    ferric carboxymaltose
    heart failure
    iron deficiency
    
    Metadata
    Show full item record
    Abstract
    Background Iron deficiency may impair aerobic performance. This study aimed to determine whether treatment with intravenous iron (ferric carboxymaltose) would improve symptoms in patients who had heart failure, reduced left ventricular ejection fraction, and iron deficiency, either with or without anemia. Methods We enrolled 459 patients with chronic heart failure of New York Heart Association (NYHA) functional class II or III, a left ventricular ejection fraction of 40% or less (for patients with NYHA class II) or 45% or less (for NYHA class III), iron deficiency (ferritin level <100 μg per liter or between 100 and 299 μg per liter, if the transferrin saturation was <20%), and a hemoglobin level of 95 to 135 g per liter. Patients were randomly assigned, in a 2:1 ratio, to receive 200 mg of intravenous iron (ferric carboxymaltose) or saline (placebo). The primary end points were the self-reported Patient Global Assessment and NYHA functional class, both at week 24. Secondary end points included the distance walked in 6 minutes and the health-related quality of life. Results Among the patients receiving ferric carboxymaltose, 50% reported being much or moderately improved, as compared with 28% of patients receiving placebo, according to the Patient Global Assessment (odds ratio for improvement, 2.51; 95% confidence interval [CI], 1.75 to 3.61). Among the patients assigned to ferric carboxymaltose, 47% had an NYHA functional class I or II at week 24, as compared with 30% of patients assigned to placebo (odds ratio for improvement by one class, 2.40; 95% CI, 1.55 to 3.71). Results were similar in patients with anemia and those without anemia. Significant improvements were seen with ferric carboxymaltose in the distance on the 6-minute walk test and quality-of-life assessments. The rates of death, adverse events, and serious adverse events were similar in the two study groups. Conclusions Treatment with intravenous ferric carboxymaltose in patients with chronic heart failure and iron deficiency, with or without anemia, improves symptoms, functional capacity, and quality of life; the side-effect profile is acceptable. (ClinicalTrials.gov number, NCT00520780.)
    Citation
    Anker, S.D. et al (2009) 'Ferric Carboxymaltose in Patients with Heart Failure and Iron Deficiency' New England Journal of Medicine 361 (25):2436
    Publisher
    New England Journal of Medicine
    Journal
    New England Journal of Medicine
    URI
    http://hdl.handle.net/10547/593448
    DOI
    10.1056/NEJMoa0908355
    PubMed ID
    19920054
    Additional Links
    http://www.nejm.org/doi/abs/10.1056/NEJMoa0908355
    Type
    Article
    Language
    en
    ISSN
    0028-4793
    1533-4406
    ae974a485f413a2113503eed53cd6c53
    10.1056/NEJMoa0908355
    Scopus Count
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    IHR Institute for Health Research

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