Randomized controlled trial2026

Fish-Oil Supplementation and Cardiovascular Events in Patients Receiving Hemodialysis

Lok CE, Farkouh M, Hemmelgarn BR, Moist LM, Polkinghorne KR, Tomlinson G, Tam P, Tonelli M, Udell JA, PISCES Investigators

The New England journal of medicine · 26 citations

How it was studied

Design
Randomized controlled trial (indexed by PubMed)
Studied in
People
Main outcome
Clinical events such as disease or death

Who paid for it

Funding
Independent funding
Nonprofit
Heart and Stroke Foundation of Canada
University or hospital
Lawson Health Research Institute
Government
National Health and Medical Research Council
Nonprofit
Peter Munk Cardiac Care Innovation Fund
Nonprofit
Kidney CARE Network International
Grants
Heart and Stroke Foundation of Canada (G-15-0009388); National Health and Medical Research Council (1123392); Heart and Stroke Foundation of Canada (Ontario Chapter, personnel award #7511-A)

Based on 5 listed funder(s).

Publication

Published
2025-11-07 · N Engl J Med · vol. 394 · issue 2 · pp. 128–137
Publisher
Massachusetts Medical Society
Cited
53 citations · more than 100% of similar papers · 30.6× the field average
Impact
Top 10% most cited in its field
References
38 works
Access
Paywalled
Research areas
Dialysis and Renal Disease Management · Fatty Acid Research and Health · Acute Kidney Injury Research
Keywords
Hemodialysis, Stroke (engine), Heart failure, Heart rate, Blood pressure, Disease
MeSH
humans, kidney failure, chronic, cardiovascular diseases, fatty acids, omega-3, docosahexaenoic acids, eicosapentaenoic acid, treatment outcome, renal dialysis, cause of death, follow-up studies, double-blind method, dietary supplements, aged, middle aged, canada, australia, female, male

9 authors

From CA, US, AU

  • Charmaine E. LokUniversity Health Network; University of Toronto; Toronto General Hospital; Toronto General Hospital Research Institute
  • Michael E. FarkouhUniversity Health Network; Cedars-Sinai Smidt Heart Institute
  • Brenda R. HemmelgarnUniversity of Alberta
  • Louise M. MOISTWestern University
  • Kevan R. PolkinghorneMonash Health; Monash University
  • GEORGE A. TOMLINSONToronto General Hospital; Toronto General Hospital Research Institute

Abstract

Background

Cardiovascular disease is the leading cause of death in patients receiving hemodialysis, yet effective preventive therapies remain limited. Supplementation with n-3 polyunsaturated fatty acids, especially eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), may have cardiovascular benefits in the general population, but efficacy among patients receiving hemodialysis is uncertain.

Methods

In a double-blind, randomized, placebo-controlled trial conducted at 26 sites in Canada and Australia, we assigned adult patients receiving maintenance hemodialysis to daily supplementation with fish oil (4 g of n-3 polyunsaturated fatty acids [1.6 g of EPA and 0.8 g of DHA]) or corn-oil placebo. The primary end point was a composite of all serious cardiovascular events including sudden and nonsudden cardiac death, fatal and nonfatal myocardial infarction, peripheral vascular disease leading to amputation, and fatal and nonfatal stroke. Secondary end points included extension of the primary end point to include noncardiac causes of death, the individual components of the primary end point, and a first cardiovascular event or death from any cause.

Results

Between November 28, 2013, and July 22, 2019, a total of 1228 participants underwent randomization; 610 were assigned to the fish-oil group and 618 to the placebo group. During 3.5 years of follow-up, the rate of serious cardiovascular events was significantly lower in the fish-oil group than in the placebo group (0.31 vs. 0.61 per 1000 patient-days; hazard ratio, 0.57; 95% confidence interval [CI], 0.47 to 0.70; P<0.001). The rate of the extended primary end point that included noncardiac causes of death appeared to be lower in the fish-oil group than in the placebo group, with a hazard ratio of 0.77 (95% CI, 0.65 to 0.90). The hazard ratio for cardiac death was 0.55 (95% CI, 0.40 to 0.75); for fatal and nonfatal myocardial infarction, 0.56 (95% CI, 0.40 to 0.80); for peripheral vascular disease leading to amputation, 0.57 (95% CI, 0.38 to 0.86); for fatal and nonfatal stroke, 0.37 (95% CI, 0.18 to 0.76); and for a first cardiovascular event or death from any cause, 0.73 (95% CI, 0.61 to 0.87). Adherence to the trial regimen and the incidence of adverse events did not differ meaningfully between the groups.

Conclusions

The rate of serious cardiovascular events among participants receiving maintenance hemodialysis was lower with daily supplementation with n-3 fatty acids than with placebo. (Supported by the Heart and Stroke Foundation of Canada and others; PISCES ClinicalTrials.gov number, ISRCTN00691795.).

Abstract via Europe PMC. Copyright remains with the authors or publisher.

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