Key result
Daily n-3 PUFA cuts all-cause mortality ~9% vs. placebo in chronic heart failure.
Why the study?
Several epidemiological and experimental studies suggested that n-3 polyunsaturated fatty acids might improve morbidity and mortality in patients with symptomatic heart failure, but this had not been tested in a large randomized trial.
Does n-3 polyunsaturated fatty acids (PUFA) 1 g daily reduce mortality and cardiovascular hospitalization in patients with chronic heart failure?
RCT (n=6,975)
double-blind
concealed, computerised telephone randomisation system
Yes
Does n-3 polyunsaturated fatty acids (PUFA) 1 g daily reduce mortality and cardiovascular hospitalization in patients with chronic heart failure?
Hazard Ratio: 0.91 (95% CI 0.833–0.998)
Absolute Event Rate: 27% vs 29%
Number Needed to Treat: 56
p-value: p=0.041
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Although the improvements in clinical outcomes were modest, they were additive to those of other therapies that are standard of care in heart failure. The therapy was safe and very well tolerated. Whilst questions remain about mechanisms of action, optimum dosing, and formulation, supplementation with n-3 polyunsaturated fatty acids should join the short list of evidence-based life-prolonging therapies for heart failure.”
“We have shown that omega-3 PUFA is effective and safe in a large population of patients with heart failure of any cause, who are receiving standard clinical care provided in hospitals and ambulatory facilities in Italy. Since we invited all cardiology centres operating in Italy to participate in this trial, and most did so, the results indicate what is likely to happen in the real world during the course of several years of polipharmacy care.”
Supplementation with 1 g daily of n-3 PUFA provides a small but statistically significant reduction in all-cause mortality and cardiovascular hospital admissions in patients with chronic heart failure.
BACKGROUND: Several epidemiological and experimental studies suggest that n-3 polyunsaturated fatty acids (PUFA) can exert favourable effects on atherothrombotic cardiovascular disease, including arrhythmias. We investigated whether n-3 PUFA could improve morbidity and mortality in a large population of patients with symptomatic heart failure of any cause. METHODS: We undertook a randomised, double-blind, placebo-controlled trial in 326 cardiology and 31 internal medicine centres in Italy. We enrolled patients with chronic heart failure of New York Heart Association class II-IV, irrespective of cause and left ventricular ejection fraction, and randomly assigned them to n-3 PUFA 1 g daily (n=3494) or placebo (n=3481) by a concealed, computerised telephone randomisation system. Patients were followed up for a median of 3.9 years (IQR 3.0-4.5). Primary endpoints were time to death, and time to death or admission to hospital for cardiovascular reasons. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00336336. FINDINGS: We analysed all randomised patients. 955 (27%) patients died from any cause in the n-3 PUFA group and 1014 (29%) in the placebo group (adjusted hazard ratio [HR] 0.91 [95.5% CI 0.833-0.998], p=0.041). 1981 (57%) patients in the n-3 PUFA group and 2053 (59%) in the placebo group died or were admitted to hospital for cardiovascular reasons (adjusted HR 0.92 [99% CI 0.849-0.999], p=0.009). In absolute terms, 56 patients needed to be treated for a median duration of 3.9 years to avoid one death or 44 to avoid one event like death or admission to hospital for cardiovascular reasons. In both groups, gastrointestinal disorders were the most frequent adverse reaction (96 [3%] n-3 PUFA group vs 92 [3%] placebo group). INTERPRETATION: A simple and safe treatment with n-3 PUFA can provide a small beneficial advantage in terms of mortality and admission to hospital for cardiovascular reasons in patients with heart failure in a context of usual care.
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GISSI-HF investigators (2008) conducted an RCT in chronic heart failure (n=6,975). n-3 polyunsaturated fatty acids vs. placebo was evaluated on time to death (HR 0.91, 95% CI 0.833-0.998, p=0.041). Treatment with 1 g daily n-3 PUFA reduced all-cause mortality compared to placebo (27% vs 29%; HR 0.91, 95.5% CI 0.833-0.998, p=0.041) in patients with chronic heart failure.
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