Ferric carboxymaltose in patients with heart failure and iron deficiency.
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 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
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).
Anker
Stefan D
SD
Department of Cardiology, Campus Virchow-Klinikum, Charité Universitätsmedizin, Berlin.
Comin Colet
Josep
J
Filippatos
Gerasimos
G
Willenheimer
Ronnie
R
Dickstein
Kenneth
K
Drexler
Helmut
H
Lüscher
Thomas F
TF
Bart
Boris
B
Banasiak
Waldemar
W
Niegowska
Joanna
J
Kirwan
Bridget-Anne
BA
Mori
Claudio
C
von Eisenhart Rothe
Barbara
B
Pocock
Stuart J
SJ
Poole-Wilson
Philip A
PA
Ponikowski
Piotr
P
D000368:Aged; D018798:Anemia, Iron-Deficiency / Q000150:complications / Q000188:drug therapy*; D002908:Chronic Disease; D005260:Female; D005290:Ferric Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D005293:Ferritins / Q000097:blood; D005500:Follow-Up Studies; D006333:Heart Failure / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D006397:Hematinics / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D000090463:Iron Deficiencies; D008297:Male; D008320:Maltose / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011788:Quality of Life; D013318:Stroke Volume / Q000187:drug effects; D018487:Ventricular Dysfunction, Left / Q000209:etiology
D005290:Ferric Compounds; D006397:Hematinics; C522335:ferric carboxymaltose; D008320:Maltose; D005293:Ferritins