Cardiovascular disease remains the leading cause of death among patients undergoing hemodialysis, yet effective preventive strategies are limited. Previous studies have suggested potential heart-protective effects of omega-3 polyunsaturated fatty acids (PUFAs)—notably eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)—in the general population. However, their role in patients with end-stage kidney disease on dialysis has been unclear until now.
In this double-blind, randomized, placebo-controlled trial conducted across 26 sites in Canada and Australia, adult hemodialysis patients were randomly assigned to receive either 4 grams of fish oil daily (containing 1.6 g EPA and 0.8 g DHA) or a corn oil placebo. The study aimed to determine whether daily supplementation could reduce the risk of major cardiovascular events, including sudden and non-sudden cardiac death, myocardial infarction, stroke, and peripheral vascular disease leading to amputation.
Between November 2013 and July 2019, a total of 1,228 participants were enrolled, with 610 assigned to the fish-oil group and 618 to the placebo group.
Key Findings:
- During an average follow-up of 3.5 years, patients receiving fish oil had a significantly lower rate of serious cardiovascular events compared with those on placebo (0.31 vs. 0.61 per 1000 patient-days; hazard ratio 0.57).
- Fish oil supplementation was associated with a reduced risk of cardiac death (HR 0.55).
- The risk of myocardial infarction was also lower among patients receiving fish oil (HR 0.56).
- A substantial reduction in stroke risk was observed with fish oil use (HR 0.37).
- The likelihood of developing peripheral vascular disease leading to amputation was decreased with fish oil supplementation (HR 0.57).
- When non-cardiac causes of death were included, the overall risk remained lower in the fish oil group (HR 0.77).
- The probability of experiencing a first cardiovascular event or death from any cause was reduced by 27% with fish oil use (HR 0.73).
- Adherence to therapy and the incidence of adverse events were comparable between the fish oil and placebo groups.
- Fish oil supplementation was well-tolerated and safe for long-term use in patients undergoing hemodialysis.
The authors concluded that daily n−3 fatty acid supplementation significantly reduced the incidence of serious cardiovascular events among individuals on maintenance hemodialysis. These findings offer a promising avenue for improving cardiovascular outcomes in this high-risk population and may influence future clinical recommendations for the use of omega-3 supplements in dialysis care.
Reference:
Lok CE, et al "Fish-oil supplementation and cardiovascular events in patients receiving hemodialysis" N Engl J Med 2025; DOI: 10.1056/NEJMoa2513032.
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