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Friday, January 18, 2013
Amgen Trial Fails To Show Benefit Of Anemia Drug In Heart Failure Patients
Amgen todayannounced the top line results of a large phase 3 heart failure trial of the drug and said the trial had failed to meet its primary endpoint.
The RED-HF (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial, which started in 2006, had randomized 2,278 patients with heart failure and anemia to receive either Aranesp or placebo. Patients in the trial started with hemoglobin levels between 9 and 12 g/dL. Physicians then sought to achieve hemoglobin concentrations between 13 and 14.5 g/dL. The company said the trial did not meet the primary endpoint of reducing the composite endpoint of time to death from any cause or first hospital admission for worsening heart failure (Hazard Ratio 1.01, CI 0.90 – 1.13).