In observational studies, higher consumption of fish is associated with lower risks of coronary artery disease and stroke. However, previous randomized trials have not been able to show that taking fish oil supplements containing omega-3 fatty acids reduce the risk of having cardiovascular events.
The ASCEND trial (A Study of Cardiovascular Events iN Diabetes) examined whether fish oil supplements reduce the risk of a cardiovascular event in patients with diabetes. Between 2005 and 2011, 15,480 patients with diabetes, but no history of cardiovascular disease, were randomly assigned to fish oil supplementation (1 g daily) or matching placebo.
The primary efficacy outcome was first serious vascular event, which included non-fatal heart attacks, non-fatal strokes or transient ischemic attacks (sometimes called “mini-strokes”), or deaths from a cardiovascular cause (but excluding any intracranial haemorrhage; ie, bleeding in the head or brain).
During an average of 7.4 years of follow-up, a first serious vascular event occurred in 689 (8.9%) participants allocated fish oil supplements and 712 (9.2%) participants allocated placebo. There was no significant difference between the two groups: rate ratio of 0.97 (95% CI, 0.87–1.08, p=0.55).
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