There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.
Abstract
Trials have shown a beneficial effect of n-3 polyunsaturated fatty acids in patients
with a previous myocardial infarction or heart failure. We evaluated the potential
benefit of such therapy in patients with multiple cardiovascular risk factors or atherosclerotic
vascular disease who had not had a myocardial infarction.
In this double-blind, placebo-controlled clinical trial, we enrolled a cohort of patients
who were followed by a network of 860 general practitioners in Italy. Eligible patients
were men and women with multiple cardiovascular risk factors or atherosclerotic vascular
disease but not myocardial infarction. Patients were randomly assigned to n-3 fatty
acids (1 g daily) or placebo (olive oil). The initially specified primary end point
was the cumulative rate of death, nonfatal myocardial infarction, and nonfatal stroke.
At 1 year, after the event rate was found to be lower than anticipated, the primary
end point was revised as time to death from cardiovascular causes or admission to
the hospital for cardiovascular causes.
Of the 12,513 patients enrolled, 6244 were randomly assigned to n-3 fatty acids and
6269 to placebo. With a median of 5 years of follow-up, the primary end point occurred
in 1478 of 12,505 patients included in the analysis (11.8%), of whom 733 of 6239 (11.7%)
had received n-3 fatty acids and 745 of 6266 (11.9%) had received placebo (adjusted
hazard ratio with n-3 fatty acids, 0.97; 95% confidence interval, 0.88 to 1.08; P=0.58).
The same null results were observed for all the secondary end points.
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 and morbidity.
(Funded by Società Prodotti Antibiotici and others; ClinicalTrials.gov number, NCT00317707.).