Key result
n-3 fatty acids (3.6 g for 4 weeks) did not significantly increase bleeding time compared to placebo (4.8 vs 4.5 min) in dialysis patients, indicating no clinically important bleeding risk.
RCT (n=16)
Double-blind
Cross-over
Absolute Event Rate: 4.8% vs 4.5%
Dialysis patients have an inordinate risk of cardiovascular events. Fish oils, rich in n-3 fatty acids, are believed to be beneficial in the prevention of atherosclerosis and thrombosis. Hence, the use of fish oils deserves consideration as a preventative or therapeutic intervention in dialysis patients. The suggestion has been made that n-3 fatty acids could increase the risk of bleeding, and thus, the safety of the use of these agents in dialysis patients must be established before long-term studies are undertaken. This study addresses the effect of n-3 fatty acids on the hemostatic profile of dialysis patients. Sixteen patients on chronic dialysis therapy were randomized to fish oil (MaxEPA) or placebo (olive oil) in a double-blind cross-over study. They received 3.6 g of n-3 fatty acids for 4 wk. Bleeding times were 4.8 +/- 0.4 min on MaxEPA and 4.5 +/- 0.3 min on placebo. Platelet aggregation to low-dose ADP or collagen also remained unchanged. There was a trend to lower serum triglyceride levels (2.7 +/- 0.5 versus 3.4 +/- 0.6 mmol/L, fish oil versus placebo) that did not reach statistical significance. Gastrointestinal side effects occurred in 10 of the 16 subjects and were severe in 5 patients. These side effects occurred in both the olive oil and the fish oil groups. The study had a 95% chance of detecting a clinically doubling significant increase in bleeding time, i.e., beta error less than 5%. In conclusion, n-3 fatty acids do not introduce a clinically important risk of bleeding for patients with end-stage renal disease.
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Donnelly et al. (1992) conducted an RCT in End-stage renal disease on chronic dialysis (n=16). Fish oil (MaxEPA) n-3 fatty acids vs. Placebo (olive oil) was evaluated on Bleeding time. n-3 fatty acids (3.6 g for 4 weeks) did not significantly increase bleeding time compared to placebo (4.8 vs 4.5 min) in dialysis patients, indicating no clinically important bleeding risk.