Amgen announced top-line results of the Phase 3 Aranesp(R) (darbepoetin alfa) RED-HF(R) (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial. The trial was initiated in 2006, and a total of 2,278 patients with symptomatic systolic heart failure and anemia (hemoglobin levels ranging from 9.0-12.0 g/dL) were randomized to receive either treatment with Aranesp to achieve a target hemoglobin of at least 13.0 g/dL (not to exceed 14.5 g/dL), or placebo. The study did not meet its primary endpoint of reducing the composite endpoint of time to death from any cause or first hospital admission for worsening heart failure.

The RED-HF Trial was designed and powered to evaluate whether the treatment of anemia could improve morbidity and mortality in systolic heart failure patients. There were no new safety findings identified in the study. The most frequently reported adverse events in the study were cardiac failure, dyspnea, diarrhea, congestive heart failure and dizziness.

These summary results will be followed by full efficacy and safety analyses, which will be shared and discussed with global regulatory agencies and submitted for presentation at an upcoming medical meeting. Aranesp is indicated for the treatment of anemia due to chronic kidney disease in patients on dialysis and not on dialysis, and for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. Aranesp has not been shown to improve quality of life, fatigue or patient well-being.

The RED-HF Trial is a large, event-driven, global, randomized, double-blind, placebo-controlled, Phase 3 study designed and powered to evaluate the effect of treatment with Aranesp on mortality and heart failure hospitalization. The primary endpoint of the study was the composite of time to death from any cause or first hospital admission for worsening heart failure in patients with symptomatic left ventricular systolic dysfunction and anemia. Secondary endpoints include time to death from any cause; time to cardiovascular death or first hospital admission for worsening heart failure, whichever occurs first; change from baseline to month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score; and change from baseline in KCCQ Symptom Frequency Score.

Patients with New York Heart Association class II, III or IV heart failure, left ventricular ejection fraction less than or equal to 40%, and hemoglobin greater than or equal to 9.0 g/dL and less than or equal to 12.0 g/dL were randomized 1:1 to receive subcutaneous Aranesp or placebo. The dose of Aranesp was titrated to gradually achieve and maintain a hemoglobin concentration of at least 13.0 g/dL, not to exceed 14.5 g/dL. Investigational product was administered initially every two weeks and extended to every month when patients were stable in the hemoglobin target range.

The RED-HF Trial was monitored by an independent Data Monitoring Committee, which reviewed the study data on a quarterly basis throughout the duration of the trial.