Study
Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia (REDUCE-IT)
4 g/day purified EPA (icosapent ethyl) reduced cardiovascular events by 25% in statin-treated patients with elevated triglycerides.
Summary Can purified fish oil lower heart and stroke risk? Show / hide ↓
Researchers gave 8,179 people taking statins, cholesterol-lowering medicines, either 4 grams a day of purified fish oil or an inactive mineral-oil treatment. Participants had high triglycerides, a type of fat in the blood, and were followed for about 4.9 years. Major heart and blood-vessel problems happened in 17.2% of the purified-fish-oil group and 22.0% of the comparison group, about a 25% lower risk. Death from heart disease was also modestly lower. However, irregular heartbeats and bleeding serious enough for hospital care were more common, and the mineral-oil treatment may have made the benefit look larger than it really was.
What this means for you: This supports discussing prescription-strength icosapent ethyl with a clinician if you fit the study’s high-risk profile. It does not show that ordinary fish-oil supplements provide the same benefit, and the possible heart-rhythm and bleeding risks matter.
solid evidenceREDUCE-IT randomized 8,179 statin-treated patients with elevated triglycerides (135-499 mg/dL) to 4 g/day icosapent ethyl (purified EPA ethyl ester) or mineral oil placebo. Over 4.9 years median follow-up, the primary composite endpoint (cardiovascular death, nonfatal MI, nonfatal stroke, coronary revascularization, or unstable angina) occurred in 17.2% vs 22.0% (HR 0.75, 95% CI 0.68-0.83, P<0.001). Cardiovascular death was reduced by 20% (4.3% vs 5.2%, HR 0.80, P=0.03). The key secondary endpoint (CV death, MI, stroke) was reduced by 26%. Number needed to treat was 21 for the primary endpoint. Atrial fibrillation was significantly increased (5.3% vs 3.9%, P<0.001), as was bleeding requiring hospitalization. The mineral oil placebo raised LDL cholesterol by 2.2%, which may have inflated the apparent benefit.
Among patients with elevated triglyceride levels despite the use of statins, the risk of ischemic events, including cardiovascular death, was significantly lower among those who received 2 g of icosapent ethyl twice daily than among those who received placebo.
The STRENGTH trial (Nicholls 2020, JAMA) did not replicate the benefit with a mixed EPA+DHA product against corn oil placebo, and its secondary analysis suggested the mineral oil placebo in REDUCE-IT may account for the apparent benefit. Both trials found increased atrial fibrillation with omega-3 treatment.
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