American Heart Association Late Breaking Clinical Trial Report: Treatment for Iron Deficiency Improves Symptoms, Functional Capacity and Quality of Life in Chronic Heart Failure Patients
Study highlights: -- Iron treatment with intravenous (I.V.) ferric carboxymaltose significantly improved symptoms, functional capacity and quality of life for Class II and III chronic heart failure (CHF) patients. -- This treatment worked equally well whether or not patients were diagnosed with anemia.
ORLANDO, Fla., Nov. 17 /PRNewswire-USNewswire/ -- Intravenous
(I.V.) iron treatment with ferric carboxymaltose to reverse iron
deficiency can significantly improve symptoms, exercise tolerance
and quality of life for chronic heart failure (CHF) patients,
researchers said in a late-breaking clinical trial presentation at
the American Heart Association's Scientific Sessions 2009.
"Our study shows that treating iron deficiency for 24 weeks with
iron in the form of I.V. ferric carboxymaltose safely improves
symptoms in patients with chronic heart failure with anemia," said
Stefan D. Anker, M.D., Ph.D., Professor of Cardiology and Cachexia
Research, Department of Cardiology, Charite Medical School in
Berlin, Germany. Anker is lead investigator of the FAIR-HF
(Ferinject(R) Assessment in patients with IRon deficiency and
chronic Heart Failure) study.
Anker added, "This is the first fully successful phase 3 trial
of a drug for chronic heart failure to improve symptoms in many
years. Besides symptoms, our treatment also improved functional
exercise capacity as measured by the 6-minute walking test and
quality of life and it was very well tolerated."
The researchers studied 459 heart failure patients with iron
deficiency in 75 study sites, mainly in Europe and Argentina.
Researchers randomized two-thirds of the patients to receive weekly
I.V. injections of iron until the iron deficiency was reversed,
with monthly treatment thereafter. The other one-third received a
The group treated with I.V. iron showed significant improvements
in both of the study's two primary endpoints: 1) self-reported
Patient Global Assessment (PGA) score after 24 weeks (P<0.0001)
and 2) a measure of CHF severity called New York Heart Association
(NYHA) class (P<0.0001). To illustrate the results, for the PGA
endpoint, 50 percent of patients assigned to ferric carboxymaltose
were either "much improved" or "moderately improved" at week 24
compared to only 28 percent of patients showing this kind of
improvement in the placebo group. For NYHA class, the study showed
that 47 percent of patients assigned to ferric carboxymaltose were
in NYHA class I or II at week 24, compared to only 30 percent of
patients on placebo therapy.
The results for PGA and NYHA class were very similar in all
predefined subgroups, regardless of whether they were defined by
hemoglobin or ferritin level, age, or gender. "It is important that
the benefits of I.V. iron were observed in patients regardless of a
diagnosis of anemia, suggesting that iron deficiency itself is an
important therapeutic target in heart failure patients, independent
of presence of anemia." said Anker.
Furthermore, researchers found significant improvements in the
secondary endpoints. After 24 weeks, patients receiving I.V. iron
injections undergoing the six-minute walk test were able to walk
39.1 meters further than at baseline, compared with just 8.6 meters
further in the placebo group.
From as early as week 4 of the study, and throughout the study,
I.V. iron improved quality of life assessments compared with
placebo (P<0.001). There was no significant difference in
mortality or rates of adverse events, including hospitalizations,
between the treatment and placebo groups.
Iron deficiency can easily be detected using a simple blood
test. "Physicians should assess patients for the presence of iron
deficiency and if it is present, I.V. iron should be considered to
improve patients' symptom status," Anker suggested.
Sponsor: Vifor Pharma Ltd., Switzerland.
Authors are: Stefan D. Anker, M.D Ph.D.; Piotr Ponikowski, M.D
Ph.D.; Philip A. Poole-Wilson, M.D. (deceased); Josep Comin Colet,
M.D.; Gerasimos Filipatos, M.D.; Ronnie Willenheimer, M.D.; Kenneth
Dickstein, M.D. Ph.D.; Helmut Drexler (deceased), M.D.; and Thomas
Lüscher, M.D.; Stuart Pocock, Ph.D; Claudio Mori, M.D.;
Barbara von Eisenhart Rothe, M.D.
Disclosures: Stefan D. Anker is a member of the Executive
Committee of FAIR-HF and a consultant to Vifor Pharma Ltd. and
Amgen Inc. He has received honoraria for speaking for the
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Source: American Heart Association
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Posted: November 2009