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The findings, from the rigorous PISCES trial published in the New England Journal of Medicine, offer hope for over half a million Americans on dialysis who face a cardiovascular risk twenty times higher than the general public.
For patients with end-stage kidney disease, dialysis is a necessity that comes with a heavy price. The process creates a pro-inflammatory and pro-arrhythmic environment, and rapid shifts in fluid and electrolytes during treatment place immense stress on the heart. This explains why heart disease is the leading cause of death in this community, accounting for a staggering three out of every four deaths.
"Dialysis is a medical process used when a person's kidneys fail, which removes toxins and waste like urea from the blood through filtration," said BrightU.AI's Enoch. "This process is similar to a house water filter and is essential for keeping the body healthy. However, it is also an exhausting procedure that strips away essential nutrients and vitamins from the patient."
The rigors of the trial
The PISCES trial was a randomized, double-blind, placebo-controlled study—the gold standard for clinical research. Over three and a half years, 1,228 hemodialysis patients were randomly assigned to take either four fish oil capsules or four identical placebo capsules containing corn oil daily. Neither patients nor their doctors knew who was receiving the actual treatment. The treatment group received a high dose of omega-3 fatty acids: 1.6 grams of EPA and 0.8 grams of DHA.
The outcomes were significant. Patients in the fish oil group experienced a 43% reduction in serious cardiovascular events compared to the placebo group. This composite endpoint included sudden cardiac death, fatal and non-fatal heart attacks, strokes and amputations. The protective effect was consistent: the risk of fatal and non-fatal stroke was slashed by 63%, the risk of heart attack fell by 44% and the risk of cardiac death dropped by 45%.
A previous randomized trial in chronic hemodialysis patients found that 1,700 mg of omega-3s daily was associated with a 70% reduction in the relative risk of myocardial infarction. Another randomized controlled trial using 3,300 mg of EPA and DHA also showed a trend toward lower cardiovascular events, with seven events in the placebo group versus only two in the fish oil group.
A primary concern with fish oil is the potential for increased bleeding, a particular worry for dialysis patients. Reassuringly, the trial found no increase in serious bleeding events or other adverse effects in the fish oil group compared to the placebo group, making it a seemingly safe intervention.