Abstract | BACKGROUND: 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 microg per liter or between 100 and 299 microg 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:
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Authors | Stefan D Anker, Josep Comin Colet, Gerasimos Filippatos, Ronnie Willenheimer, Kenneth Dickstein, Helmut Drexler, Thomas F Lüscher, Boris Bart, Waldemar Banasiak, Joanna Niegowska, Bridget-Anne Kirwan, Claudio Mori, Barbara von Eisenhart Rothe, Stuart J Pocock, Philip A Poole-Wilson, Piotr Ponikowski, FAIR-HF Trial Investigators |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 361
Issue 25
Pg. 2436-48
(Dec 17 2009)
ISSN: 1533-4406 [Electronic] United States |
PMID | 19920054
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright 2009 Massachusetts Medical Society |
Chemical References |
- Ferric Compounds
- Hematinics
- ferric carboxymaltose
- Maltose
- Ferritins
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Topics |
- Aged
- Anemia, Iron-Deficiency
(complications, drug therapy)
- Chronic Disease
- Female
- Ferric Compounds
(adverse effects, therapeutic use)
- Ferritins
(blood)
- Follow-Up Studies
- Heart Failure
(blood, complications, drug therapy, physiopathology)
- Hematinics
(adverse effects, therapeutic use)
- Humans
- Iron Deficiencies
- Male
- Maltose
(adverse effects, analogs & derivatives, therapeutic use)
- Quality of Life
- Stroke Volume
(drug effects)
- Ventricular Dysfunction, Left
(etiology)
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