Darbepoetin Alfa May Treat Anemia in Heart Failure

Results of a phase 3 trial announced here at the 55th annual scientific
session of the American College of Cardiology could expand the indication
for darbepoetin alfa (Aranesp, Amgen, Inc, Thousand Oaks, California) to
include, rather than conditionally exclude, patients with heart failure.

Anemia is a common complication of heart failure and is associated with
increased morbidity and mortality. However, the labeling for darbepoetin
alfa includes a warning against giving it to patients with heart and blood
vessel disease because the drug may cause worsening of the disease.

In the Reduction of Events with Darbepoetin alfa in Heart Failure (RED-HF),
Dirk J. van Veldhuisen, MD, PhD, from the Department of Cardiology/Thoracic
Surgery at the University Medical Center in Groningen, the Netherlands, and
associates randomized 165 patients with symptomatic heart failure and anemia
to a weight-based dose of darbepoetin alfa, 0.75 µg/kg, a fixed dose of
darbepoetin 0.50 µg, or placebo administered subcutaneously every 2 weeks
for 26 weeks. Target hemoglobin levels were 14.0 (±1.0) g/dL.

At baseline, all patients were in New York Heart Association class II to IV
heart failure, had at least a 3-month history of heart failure, left
ventricular ejection fraction of 40% or below, and also had hemoglobin
levels between 9.0 and 12.5 g/dL.

The RED-HF investigators saw a significant improvement in hemoglobin levels,
with increases in hemoglobin similar between the 2 treatment groups at 0.05
g/dL per week (P = .09). Six-minute walk distance also improved in treated
patients vs placebo (34.2 min vs 11.4 min; P = .074) and patients' quality
of life, assessed by 3 different scores, all showed nonsignificant
improvements in the darbepoetin group compared with placebo.

Adverse effects were similar between the 2 groups, the researchers reported.

"Despite medical advances, heart failure and its complications are a leading
cause of death and hospitalization worldwide, and there remains a
significant unmet medical need for effective treatments for these patients,"
Willard Dere, MD, chief medical officer at Amgen, said in a release
accompanying the trial's presentation.

James B. Young, MD, medical director of the Kaufman Center for Heart Failure
at the Cleveland Clinic Foundation in Ohio, told Medscape that 20% to 30% of
patients with heart failure are anemic, and anemia in heart failure is
associated with a poorer outcome. "We're unsure of the pathologic
correlation between heart failure and anemia, but [RED-HF] shows that anemia
can be successfully treated, and the anemia responds [to darbepoetin] as it
does in any other condition."

Regarding the treatment approach to anemia in heart failure, Dr. Young
added, "We want to increase the hemoglobin level over approximately a 3-week
time. We don't want to go too fast or too slow."

posted by Smile Community @ 6:48 PM