Fish oil fails in large Phase III trial

Italian researchers reported that a once-daily 1 g dose of N-3 polyunsaturated fatty acids missed the primary endpoint in a Phase III trial in 12,513 patients with multiple cardiovascular risk factors or atherosclerotic vascular disease who had not had a myocardial infarction (MI). The primary endpoint of the double-blind trial was the composite incidence of death from cardiovascular causes or hospital admission for cardiovascular causes at a median follow-up of five years (11.7% for fish oil vs. 11.9% for placebo, p=0.58).

Data were published late Wednesday in the New England Journal of Medicine by a group at the Mario Negri Institute for Pharmacological Research (Milan, Italy). This is the first large-scale trial to evaluate fatty acids to lower cardiovascular risk. ...