Martha Kerr

March 21, 2006

March 21, 2006 (Atlanta) — Results of a phase 2 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, MedlinePlus, a service of the US National Institutes of Health and the National Library of Medicine, has issued a warning against giving darbepoetin alfa to patients with heart and blood vessel disease because the drug may cause worsening of the disease.

In the phase 2 trial laying the groundwork for 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 nonsignificantly 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, with the difference becoming statistically significant in the Kansas City Cardiomyopathy Questionnaire (8.5% for darbepoetin alfa and 1.5% for placebo; P = .027).

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."

Dr. Young said a major international trial of darbepoetin alfa for anemia in heart failure is in the works. "We're pretty bullish on the concept. It's a whole new way to treat heart failure — it's not just another pill."

ACC 55th Annual Scientific Session: Abstract 816-5. Presented March 13, 2006.

Reviewed by Ariana Del Negro

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