Prevention of Fatal Arrhythmias in High-Risk Subjects by Fish Oil n-3 Fatty Acid Intake

Study answer

What this study found

Fish oil did not reach statistical significance for the primary end point of time to first ICD event or death, but it showed a favorable trend and signal in secondary and adherence-based analyses. At 12 months, events occurred in 28% of the fish oil group (n=57) versus 39% of the placebo group (n=78), with a relative risk of 0.72; when probable events were added, the relative risk was 0.69 (95% CL, 0.49 to 0.97; P=0.033), and multivariate adjustment gave an RR of 0.67 (95% CL, 0.49 to 0.97; P=0.024). On-treatment analysis for patients treated for at least 11 months favored fish oil as well…

Study & population

Multicenter randomized trial in adults with implanted cardioverter-defibrillators at high risk for fatal ventricular arrhythmias.

Intervention

Participants received 4 1.0-g gelatin capsules daily of an ethyl ester concentrate of n-3 fatty acids from fish oil, providing a total EPA plus DHA dose of 2.6 g per day, for 12 months.

Key limitation

The primary endpoint narrowly missed conventional statistical significance (P=0.057), so the main claim rests partly on expanded-event and on-treatment analyses that are more vulnerable to bias.

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Original abstract