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. 2020 Jan-Feb;117(1):65–69.

Table 2.

Recent Fish Oil Trial Failures and Reasons Explaining Their Failure3, 2830

Study Population Potential reasons for failure
OMEGA 3,851 patients with a history of acute MI Used a low dose of omega-3 (1 gram), short duration (1 year), inappropriate use of olive oil as a placebo, high baseline intake of fish, unexpected low rate of sudden cardiac death and use of aggressive background medical treatment and the study lacked power to show benefit.
Alpha Omega 4,837 patients with a history of MI Patients were already receiving antihypertensive, anti-thrombotic, and lipid-modifying therapies.
SU.FOL.OM3 trial Low dose of omega-3 used (380 mg of EPA/DHA). Small power to detect any positive effect of omega-3s, low major vascular cardiovascular disease events were 15% lower than initially expected, insufficient duration and follow-up. Average time to start omega-3s from cardiovascular event was 101 days compared to 16 days in GISSI-P. Higher use of angiotensin converting enzyme inhibitors and angiotensin II receptor blockers at baseline in the placebo vs. the omega-3 group. Higher number of patents with a history of myocardial infarction and current smoker status in the omega-3 group compared to placebo.
ORIGIN 11,119 patients with high risk of cardiovascular disease and impaired glucose tolerance or diabetes Low dose of omega-3 (1 gram/day) used and high background intake of omega-3 fatty acids in study participants.