Effects of n-3 Fatty Acid Supplements in Elderly Patients after Myocardial Infarction: A Randomized Controlled Trial.

Randomized controlled trial in elderly adults aged 70 to 82 years who had recently survived an acute myocardial infarction and were receiving guideline-directed secondary prevention. The active n-3 PUFA arm included 505 participants randomized in a 1:1 trial conducted across multiple centers in Norway.

Oral Pikasol® n-3 PUFA capsules provided 1.8 g/day total marine omega-3, consisting of 930 mg EPA plus 660 mg DHA. The regimen was 3 capsules daily for 2 years, added to standard secondary prevention after myocardial infarction.

Daily n-3 PUFA supplementation did not reduce recurrent cardiovascular events or all-cause mortality in this elderly post-MI population. The primary composite MACE outcome was 21.4% versus 20.0% (HR 1.07, 95% CI 0.82 to 1.40; p=0.62), and all-cause mortality was 5.54% versus 5.50% (HR 1.01, 95% CI 0.60 to 1.71; p=0.97). Nonfatal myocardial infarction, stroke, heart failure hospitalization, and unscheduled revascularization were also not significantly different. New-onset atrial fibrillation was numerically higher with n-3 PUFA (7.2% vs 4.0%; HR 1.84, 95% CI 0.98 to 3.45; p=0.06), while major bleeding was similar (10.7% vs 11.0%; p=0.87).

Event rates for several endpoints were modest, leaving wide confidence intervals around effect estimates. Follow-up was limited to 2 years, and the cohort was highly selected and predominantly Caucasian elderly Norwegian post-MI patients, which limits generalizability. Baseline use of n-3 supplements or cod liver oil was common, potentially reducing the incremental contrast between groups.