Effects of n-3 PUFA in patients with symptomatic chronic heart failure: the GISSI-HF results. 

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Methods. We undertook a randomised, double blind, placebo controlled trial in 357 cardiology sites in Italy. We enrolled 6975 patients with chronic heart failure of New York Heart Association class II-IV, assigned to n-3 PUFA 1 g daily or placebo. Patients were followed up for a median of 3·9 years. Primary end-points were time to death and time to death or admission to hospital for cardiovascular reasons. Analysis was by intention-to-treat population.

Findings. 955 (27%) patients died from any cause in the n-3 PUFA group and 1014 (29%) in the placebo group (relative risk reduction 9%, 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 (relative risk reduction 8%, p=0·009). In absolute terms, 56 patients needed to be treated for 3.9 years to avoid one death or 44 to avoid one event like death or admission to hospital for cardiovascular reasons. In a per-protocol analysis performed in about 5000 full complier patients, the relative risk of death was reduced by 14% (p 0.004). Safety was excellent. Interpretation. A simple, safe  and cheap treatment with n-3 PUFA can provide a moderate beneficial advantage in terms of mortality and admission to hospital for cardiovascular reasons in patients with  chronic heart failure in a context of usual care.