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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 citas

Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Eventos clínicos como enfermedad o muerte

Quién lo pagó

Financiación
Financiación independiente
Organización sin fines de lucro
Heart and Stroke Foundation of Canada
Universidad u hospital
Lawson Health Research Institute
Gobierno
National Health and Medical Research Council
Organización sin fines de lucro
Peter Munk Cardiac Care Innovation Fund
Organización sin fines de lucro
Kidney CARE Network International
Subvenciones
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)

Según 5 financiadores declarados.

Publicación

Publicado
2025-11-07 · N Engl J Med · vol. 394 · número 2 · págs. 128–137
Editorial
Massachusetts Medical Society
Citado
53 citas · más que el 100% de estudios similares · 30.6× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
38 trabajos
Acceso
De pago
Áreas de investigación
Dialysis and Renal Disease Management · Fatty Acid Research and Health · Acute Kidney Injury Research
Palabras clave
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 autores

  • Charmaine E. Lok🇨🇦University Health Network; University of Toronto; Toronto General Hospital; Toronto General Hospital Research Institute
  • Michael E. Farkouh🇨🇦🇺🇸University Health Network; Cedars-Sinai Smidt Heart Institute
  • Brenda R. Hemmelgarn🇨🇦University of Alberta
  • Louise M. MOIST🇨🇦Western University
  • Kevan R. Polkinghorne🇦🇺Monash Health; Monash University
  • GEORGE A. TOMLINSON🇨🇦Toronto General Hospital; Toronto General Hospital Research Institute
  • Paul YW Tam🇨🇦University Health Network; Scarborough Health Network
  • Marcello A. Tonelli🇨🇦University of Calgary
  • Jacob Allen Udell🇨🇦University Health Network; University of Toronto; Women's College Hospital

Resumen

El texto original del estudio, en el idioma en que se publicó.

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.).

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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