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Patients with HF failed to benefit from Aranesp
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The phase 3 RED-HF trial designed to evaluate darbepoetin alfa in patients with HF failed to decrease time to death or first hospital admission for worsening HF, Amgen announced in a press release.
The Reduction of Events with Darbepoetin Alfa Heart Failure (RED-HF) enrolled 2,278 patients with NYHA Class II, III or IV HF and anemia, defined as hemoglobin ranging from 9 to 12 g/dL. Patients were randomly assigned treatment with darbepoetin (Aranesp) or placebo with the goal of reaching 13 g/dL without exceeding 14.5 g/dL.
According to the release, the study did not meet its primary endpoint of reducing the composite endpoint of time to all-cause death or first hospital admission to worsening HF (HR=1.01; 95% CI, 0.9-1.13).
Investigators reported the most frequent adverse events were cardiac failure, dyspnea, diarrhea, congestive HF and dizziness.
A full efficacy and safety analysis will be prepared and distributed to global regulatory agencies.
Aranesp is prescribed for treating anemia due to chronic kidney disease for both patients on and not on dialysis.
The FDA approved Aranesp to treat anemia in patients undergoing chemotherapy with non-myeloid malignancies, according to the release.