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AFFORD: High-dose fish oil failed to reduce AF recurrence
Use of high-dose fish oil did not reduce the recurrence of atrial fibrillation in patients with prior atrial fibrillation who were not receiving conventional antiarrhythmic therapy, according to data from the AFFORD trial.
Fish oil also did not reduce inflammation or oxidative stress markers in that patient population, researchers found.
Previous trials of fish oil for the recurrence of AF were mixed, leading to uncertainty about the roles of high-dose fish oil, inflammation and oxidative stress in patients with paroxysmal or persistent AF not receiving conventional antiarrhythmic therapy, according to the study background.
Anil Nigam, MD, from the department of medicine at Montreal Heart Institute, Université de Montréal, Canada, and colleagues conducted the double blind, randomized, placebo-controlled, parallel-arm AFFORD trial of 337 patients who had symptomatic paroxysmal or persistent AF within 6 months of enrollment.
Patients were randomly assigned to fish oil 4 g/day, a higher dose than in most previous studies, or placebo. Mean follow-up was 271 days. Patients in the fish oil group received four 1-g enteric-coated capsules of fish oil per day. Each capsule contained 400 mg eicosapentaenoic acid and 200 mg docosahexaenoic acid.
The primary endpoint was time to first symptomatic or asymptomatic AF recurrence lasting longer than 30 seconds. Secondary endpoints included high-sensitivity C-reactive protein and myeloperoxidase measured at baseline and at 6 months.
Nigam and colleagues reported that the primary endpoint occurred in 64.1% of patients assigned fish oil and 63.2% of those assigned placebo (HR=1.1; 95% CI, 0.84-1.45).
High-sensitivity CRP decreased a similar amount for both groups (fish oil, –11%; placebo, –11%; P=.9), as did myeloperoxidase (fish oil, –5%; placebo, –9%; P=.3).
“The lack of a beneficial effect of fish oil on AF recurrence in the AFFORD [trial] may be at least partially due to its lack of effect on [systemic markers of inflammation and oxidative stress], which have been implicated in AF development and progression,” Nigam and colleagues wrote. “We believe that our results provide conclusive evidence that fish oil has no role in the rhythm-control management of patients with paroxysmal or persistent AF.”
Disclosure: The trial was funded by a grant from the Canadian Institutes for Health Research and the Heart and Stroke Foundation of Quebec. One researcher reports financial ties with Amgen, Applied Clinical Intelligence, Fusion Conferences, Genzyme, Merck, Prime Therapeutics and Regeneron.