ORIGIN n-3 Fatty Acids
Trial question
What is the role of n-3 fatty acids in patients with or at risk for T2DM mellitus?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 12536
12536 patients (4386 female, 8150 male).
Inclusion criteria: patients who were at high risk for CV events and had impaired fasting glucose, impaired glucose tolerance, or diabetes.
Key exclusion criteria: unwilling to discontinue use of a nonstudy preparation of n-3 fatty acids, glycated hemoglobin level ≥ 9%, CABG within the previous 4 years with no intervening cardiovascular event, severe HF, or cancer that might affect survival.
Interventions
N=6281 n-3 fatty acid supplementation (1 g capsule containing at least 900 mg of ethyl esters).
N=6255 placebo (capsule containing 1 g of olive oil).
Primary outcome
CV death
9.1%
9.3%
9.3 %
7.0 %
4.7 %
2.3 %
0.0 %
N-3 fatty acid
supplementation
Placebo
No significant
difference ↔
No significant difference in CV death (9.1% vs. 9.3%; HR 0.98, 95% CI 0.87 to 1.1).
Secondary outcomes
No significant difference in major vascular events (16.5% vs. 16.3%; HR 1.01, 95% CI 0.93 to 1.1).
No significant difference in death from any cause (15.1% vs. 15.4%; HR 0.98, 95% CI 0.89 to 1.07).
No significant difference in arrhythmic death (4.6% vs. 4.1%; HR 1.1, 95% CI 0.93 to 1.3).
Safety outcomes
No significant difference in adverse effects.
Significant differences in triglycerides (-23.5 vs. -9.0 mg/dL, p < 0.001).
Conclusion
In patients who were at high risk for CV events and had impaired fasting glucose, impaired glucose tolerance, or diabetes, n-3 fatty acid supplementation was not superior to placebo with respect to CV death.
Reference
ORIGIN Trial Investigators, Bosch J, Gerstein HC et al. n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia. N Engl J Med. 2012 Jul 26;367(4):309-18.
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