Amgen to explore anemia in CV patients

World biotechnology major Amgen has reported Phase II study data that showed its anemia drug Aranesp (darbepoetin alfa) to be well-tolerated, and effective in raising hemoglobin levels and improving symptoms, as measured by the Kansas City Cardiomyopathy Questionnaire, in patients with heart failure.

Investigators concluded that the erythropoetic protein drug effectively raised Hb levels, significantly improved KCCQ total symptom score, 8.2 versus placebo 1.5 (p=0.027) and had a similar adverse event profile as previously seen in clinical trials. Statistically non-significant improvements in patient's global assessment 65% vs 49% (p=0.057) were seen, as well as a 22.8 meter increase in six-minute walk distance (p=0.074).

Based on the evaluation of the results, which were presented at the 2006 American College of Cardiology scientific sessions, the firm has initiated the Phase III Reduction of Events with Darbepoetin alfa in Heart Failure Trial, a randomized, double-blind, placebo-controlled, multicenter, multinational study that will evaluate the effect of Aranesp anemia treatment on morbidity and mortality in patients with symptomatic heart failure.