Ferric carboxymaltose in patients with heart failure and iron deficiency

2.50
Hdl Handle:
http://hdl.handle.net/10547/593448
Title:
Ferric carboxymaltose in patients with heart failure and iron deficiency
Authors:
Anker, Stefan D.; Comin Colet, Josep; Filippatos, Gerasimos; 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
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
Issue Date:
17-Dec-2009
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
Appears in Collections:
IHR Institute for Health Research

Full metadata record

DC FieldValue Language
dc.contributor.authorAnker, Stefan D.en
dc.contributor.authorComin Colet, Josepen
dc.contributor.authorFilippatos, Gerasimosen
dc.contributor.authorWillenheimer, Ronnieen
dc.contributor.authorDickstein, Kennethen
dc.contributor.authorDrexler, Helmuten
dc.contributor.authorLüscher, Thomas F.en
dc.contributor.authorBart, Borisen
dc.contributor.authorBanasiak, Waldemaren
dc.contributor.authorNiegowska, Joannaen
dc.contributor.authorKirwan, Bridget-Anneen
dc.contributor.authorMori, Claudioen
dc.contributor.authorvon Eisenhart Rothe, Barbaraen
dc.contributor.authorPocock, Stuart J.en
dc.contributor.authorPoole-Wilson, Philip A.en
dc.contributor.authorPonikowski, Piotren
dc.date.accessioned2016-01-14T12:10:17Zen
dc.date.available2016-01-14T12:10:17Zen
dc.date.issued2009-12-17en
dc.identifier.citationAnker, S.D. et al (2009) 'Ferric Carboxymaltose in Patients with Heart Failure and Iron Deficiency' New England Journal of Medicine 361 (25):2436en
dc.identifier.issn0028-4793en
dc.identifier.issn1533-4406en
dc.identifier.pmid19920054en
dc.identifier.doi10.1056/NEJMoa0908355en
dc.identifier.urihttp://hdl.handle.net/10547/593448en
dc.description.abstractBackground 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.)en
dc.language.isoenen
dc.publisherNew England Journal of Medicineen
dc.relation.urlhttp://www.nejm.org/doi/abs/10.1056/NEJMoa0908355en
dc.rightsArchived with thanks to New England Journal of Medicineen
dc.subjectferric carboxymaltoseen
dc.subjectheart failureen
dc.subjectiron deficiencyen
dc.titleFerric carboxymaltose in patients with heart failure and iron deficiencyen
dc.typeArticleen
dc.identifier.journalNew England Journal of Medicineen

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