Phase III trial of darbepoetin alfa (Aranesp) in heart failure fails to meet primary efficacy endpoint

Source: PharmaLive Area: News Amgen has announced that its phase III Aranesp® (darbepoetin alfa) RED-HF® (Reduction of Events With Darbepoetin Alfa in Heart Failure) trial has failed to meet its primary efficacy endpoint.   The trial was initiated in 2006, and recruited 2278 patients with symptomatic systolic heart failure and anaemia (haemoglobin 9.0 to 12.0 g/dL) who were randomised to receive either treatment with darbepoetin to achieve a target haemoglobin of at least 13.0 g/dL (not to exceed 14.5 g/dL), or placebo. The study primary endpoint was a reduction in the composite endpoint of time to death from any cause or first hospital admission for worsening heart failure (hazard ratio 1.01, 95 CI, 0.90 to 1.13). There were no new safety findings identified in the study. The most frequently reported adverse events in the study were cardiac failure, dyspnoea, diarrhoea, congestive heart failure and dizziness.   These data will be followed by full efficacy and safety analyses, which will be ...
Source: NeLM - Cardiovascular Medicine - Category: Cardiology Source Type: news