Long-term study of 12,500 patients with multiple risk factors found no benefit
Patients with multiple cardiovascular (CV) risk factors are not able to reduce their mortality risk from CV causes with daily n-3 polyunsaturated fatty acid intake, according to a long-term Italian study published May 9 in the New England Journal of Medicine.
More than 12,500 patients with multiple CV risk factors or atherosclerotic vascular disease who had not experienced a myocardial infarction were enrolled in a double-blind, placebo-controlled study. They were followed for a median of 5 years by 860 general practitioners in Italy. Patients were randomly assigned to receive a daily 1-g dose of n-3 fatty acids or olive oil, which served as the placebo.
At the end of 1 year, the rate of death, nonfatal myocardial infarction, and nonfatal stroke was lower than the researchers had expected. The researchers changed the primary end point of the study to death from CV causes or hospitalization following a CV event.
At a median of 5 years, 11.8% of patients had died or been hospitalized for CV causes-the new primary end point. Of the 1,478 patients who died or were hospitalized, a similar percentage had received daily n-3 fatty acids (11.7%) compared with those in the placebo-treated group (11.9%). The adjusted hazard ratio with n-3 fatty acids was 0.97 (95% confidence interval, 0.88 to 1.08; P=.58).
“In a large general-practice cohort of patients with multiple cardiovascular risk factors, daily treatment with n-3 fatty acids did not reduce cardiovascular mortality or morbidity,” the authors concluded.