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Ferric Carboxymaltose in Patients with Heart Failure and Iron Deficiency.

Anker, Stefan D; Comin Colet, Josep; Filippatos, Gerasimos; Willenheimer, Ronnie LU ; Dickstein, Kenneth; Drexler, Helmut; Lüscher, Thomas F; Bart, Boris; Banasiak, Waldemar and Niegowska, Joanna, et al. (2009) In New England Journal of Medicine 361. p.2436-2448
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 mug per liter or between 100 and 299 mug per liter, if the transferrin saturation was <20%), and a hemoglobin level of 95 to 135 g per liter.... (More)
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 mug per liter or between 100 and 299 mug 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.) Copyright 2009 Massachusetts Medical Society. (Less)
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New England Journal of Medicine
volume
361
pages
2436 - 2448
publisher
Massachusetts Medical Society
external identifiers
  • wos:000272798900008
  • pmid:19920054
  • scopus:72449156527
ISSN
0028-4793
DOI
10.1056/NEJMoa0908355
language
English
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yes
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0eafcd6d-d001-4beb-866a-d3dfd5c665bd (old id 1511843)
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http://www.ncbi.nlm.nih.gov/pubmed/19920054?dopt=Abstract
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2009-12-03 14:47:00
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2017-12-10 04:43:33
@article{0eafcd6d-d001-4beb-866a-d3dfd5c665bd,
  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 &lt;100 mug per liter or between 100 and 299 mug per liter, if the transferrin saturation was &lt;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.) Copyright 2009 Massachusetts Medical Society.},
  author       = {Anker, Stefan D and Comin Colet, Josep and Filippatos, Gerasimos and Willenheimer, Ronnie and Dickstein, Kenneth and Drexler, Helmut and Lüscher, Thomas F and Bart, Boris and Banasiak, Waldemar and Niegowska, Joanna and Kirwan, Bridget-Anne and Mori, Claudio and von Eisenhart Rothe, Barbara and Pocock, Stuart J and Poole-Wilson, Philip A and Ponikowski, Piotr},
  issn         = {0028-4793},
  language     = {eng},
  pages        = {2436--2448},
  publisher    = {Massachusetts Medical Society},
  series       = {New England Journal of Medicine},
  title        = {Ferric Carboxymaltose in Patients with Heart Failure and Iron Deficiency.},
  url          = {http://dx.doi.org/10.1056/NEJMoa0908355},
  volume       = {361},
  year         = {2009},
}