ω-3 Fatty Acids, but Not Rosuvastatin, Lower 4-Year Mortality in Heart Failure Patients

Randomized trials have shown that, among patients with established coronary artery disease, supplementation with ω-3 polyunsaturated fatty acids (PUFAs) or statins is associated with better outcomes than is no supplementation, but these trials were not designed to examine the effects of such interventions in heart failure patients. Because observational studies have suggested that these therapies might improve cardiovascular outcomes in heart failure patients, Italian researchers conducted a large trial (sponsored by the manufacturer of rosuvastatin [Crestor]) in which 6975 adult patients (mean age, 67) with New York Heart Association class II–IV heart failure were randomized to receive daily ω-3 PUFAs (eicosapentaenoic and docosahexaenoic acids; 1 g) or placebo. Two thirds of these patients had no indications or contraindications for statins and were randomized further to receive daily rosuvastatin (10 mg) or placebo. Standard treatments for chronic heart failure were encouraged.

Median follow-up was 3.9 years. Fewer patients in the ω-3 PUFA arms than in the placebo arms died (27% vs. 29%), and fewer patients in the ω-3 PUFA arms reached the composite primary endpoint of all-cause death or cardiovascular-related hospitalization (57% vs. 59%). These differences became statistically significant only after adjustment for several baseline imbalances between the ω-3 PUFA and placebo groups. A lower incidence of arrhythmic death in patients who received ω-3 PUFAs accounted for most of the difference in number of deaths between treatment groups. No differences were observed between patients randomized to rosuvastatin and those who received placebo in either all-cause mortality or the composite endpoint.