Περίληψη:
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.)
N Engl J Med 2009;361:2436-48.
Συγγραφείς:
Anker, Stefan D.
Comin Colet, Josep
Filippatos, Gerasimos and
Willenheimer, Ronnie
Dickstein, Kenneth
Drexler, Helmut and
Luescher, Thomas F.
Bart, Boris
Banasiak, Waldemar and
Niegowska, Joanna
Kirwan, Bridget-Anne
Mori, Claudio
Rothe,
Barbara von Eisenhart
Pocock, Stuart J.
Poole-Wilson, Philip A.
and Ponikowski, Piotr
FAIR-HF Trial Investigators
