Cardiovascular outcome trial · N Engl J Med 2018
ASCEND trial
Effects of n-3 Fatty Acid Supplements in Diabetes Mellitus.
The bottom line
In diabetic patients without known cardiovascular disease, daily 1-g omega-3 fatty acid supplementation did not reduce serious vascular events compared with placebo.
No significant benefitUS status: OTC supplement / Rx omega-3 ethyl esters
At a glance
- Medicine
- n-3 fatty acid 1-g capsules daily (fatty acid group)
- Compared with
- Placebo (olive oil)
- People
- 15,480
- Who took part
- Patients with diabetes mellitus but without evidence of atherosclerotic cardiovascular disease
- Design
- Randomized, placebo-controlled trial
- Follow-up
- mean follow-up of 7.4 years
- Main question
- First serious vascular event (nonfatal myocardial infarction or stroke, transient ischemic attack, or vascular death, excluding confirmed intracranial hemorrhage)
Main result
A serious vascular event occurred in 689 patients (8.9%) in the fatty acid group and in 712 (9.2%) in the placebo group (rate ratio, 0.97; 95% CI, 0.87 to 1.08; P=0.55)
Other results
Death from any cause occurred in 752 patients (9.7%) in the fatty acid group and in 788 (10.2%) in the placebo group (rate ratio, 0.95; 95% CI, 0.86 to 1.05). The composite outcome of a serious vascular event or revascularization occurred in 882 patients (11.4%) and 887 patients (11.5%), respectively (rate ratio, 1.00; 95% CI, 0.91 to 1.09).
Safety
There were no significant between-group differences in the rates of nonfatal serious adverse events.
In the trial's own words
“During a mean follow-up of 7.4 years (adherence rate, 76%), a serious vascular event occurred in 689 patients (8.9%) in the fatty acid group and in 712 (9.2%) in the placebo group (rate ratio, 0.97; 95% confidence interval [CI], 0.87 to 1.08; P=0.55).”
Quoted from the abstract of N Engl J Med 2018, checked word for word against PubMed. PubMed 30146932 · Full paper (DOI)
Common questions
What did the ASCEND trial find?
In diabetic patients without known cardiovascular disease, daily 1-g omega-3 fatty acid supplementation did not reduce serious vascular events compared with placebo.
Who was in ASCEND?
15,480 people. Patients with diabetes mellitus but without evidence of atherosclerotic cardiovascular disease.
What was ASCEND's main result?
A serious vascular event occurred in 689 patients (8.9%) in the fatty acid group and in 712 (9.2%) in the placebo group (rate ratio, 0.97; 95% CI, 0.87 to 1.08; P=0.55)
Related trials
- REDUCE-IT (2019)In statin-treated patients with elevated triglycerides, icosapent ethyl significantly reduced cardiovascular events including cardiovascular death, though at the cost of more atrial fibrillation hospitalizations and a trend toward more serious bleeding.
- VITAL (2019)Daily supplementation with 1 g marine omega-3 fatty acids did not reduce the incidence of major cardiovascular events or invasive cancer compared with placebo, though it was safe and reduced total myocardial infarction as a secondary finding.
- STRENGTH (2020)In statin-treated high-risk patients, adding high-dose omega-3 carboxylic acids to usual therapy did not reduce major adverse cardiovascular events compared with corn oil and caused more GI side effects.
- HPS2-THRIVE (2014)Adding extended-release niacin-laropiprant to statin therapy in patients with vascular disease did not reduce major vascular events and increased serious adverse effects, including new-onset diabetes, infection, and bleeding.
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