"N-3 Fatty Acids in High-Risk Patients with Dysglycemia". The New England Journal of Medicine. 2012. 367(4):309-318. PubMed
Links to original sources: Wiki Journal Post Full Journal Article
Contents 1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcome 8.2 Secondary Outcomes 9 Criticisms 10 Funding 11 Further Reading
In high-risk patients with dysglycemia, does daily supplementation with n-3 fatty acids reduce the rate of cardiovascular events?
Daily supplementation with 1 g of n-3 fatty acids did not reduce the rate of cardiovascular events in high-risk patients with dysglycemia.
Patients with type 2 diabetes or at high risk for diabetes are at an increased risk of cardiovascular events. Previous studies have suggested that n-3 fatty acids may have cardiovascular benefits, but evidence in patients with dysglycemia has been limited.
At the time of the study publication, the usage of n-3 fatty acids for the reduction of cardiovascular events in high-risk patients with dysglycemia was not established in guidelines.
- Multicenter, double-blind, parallel-group, randomized, placebo-controlled trial - N=12,536 - Interventions: 1 g capsule of at least 900 mg (90% or more) ethyl esters of n-3 fatty acids (n=6,281) or placebo (n=6,255) - Median follow-up: 6.2 years
- Inclusion Criteria: Patients ≥50 years old with impaired fasting glucose, impaired glucose tolerance, or diabetes at high risk for cardiovascular events - Exclusion Criteria: Unwillingness to discontinue non-study n-3 supplements, HbA1c ≥9%, recent CABG without subsequent cardiovascular event, severe heart failure, active cancer affecting survival - Baseline Characteristics: Mean age 64 years, 65% men, 59% had previous myocardial infarction, stroke, or revascularization
- 1 g capsule of n-3 fatty acids daily containing 465 mg of EPA and 375 mg of DHA - Placebo capsule containing approximately 1 g of olive oil
Primary Outcome - Death from cardiovascular causes: 9.1% in n-3 fatty acids group vs. 9.3% in placebo group (HR 0.98; 95% CI, 0.87 to 1.10; P=0.72)
- Major vascular events: 16.5% vs. 16.3% (HR 1.01; 95% CI, 0.93 to 1.10; P=0.81) - Death from any cause: 15.1% vs. 15.4% (HR 0.98; 95% CI, 0.89 to 1.07; P=0.63) - Death from arrhythmia: 4.6% vs. 4.1% (HR 1.10; 95% CI, 0.93 to 1.30; P=0.26) - Triglyceride levels reduced by 14.5 mg per deciliter more in n-3 fatty acids group (P<0.001)
- The daily dose of n-3 fatty acids may have been too low to demonstrate a benefit. - Assessment of the effect of n–3 fatty acids based on dietary intake was conducted through a questionnaire rather than serum level measurement.
- Funded by Sanofi, with study drugs provided by Pronova BioPharma Norge.
- Gerstein H. C. et al. "Basal Insulin and Cardiovascular and Other Outcomes in Dysglycemia." The New England Journal of Medicine, 2012. - Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial investigators at NEJM.org.