Effect of n-3 polyunsaturated fatty acids and rosuvastatin in patients with heart failure: results of the GISSI-HF trial.

Author(s): Marchioli R, Levantesi G, Silletta MG, Barlera S, Bernardinangeli M, Carbonieri E, Cosmi F, Franzosi MG, Latini R, Lucci D, Maggioni AP, Moretti L, Nicolosi GL, Porcu M, Rossi MG, Tognoni G, Tavazzi L, GISSI-HF Investigators

Affiliation(s): Consorzio Mario Negri Sud, Santa Maria Imbaro, Italy. marchioli@negrisud.it

Publication date & source: 2009-07, Expert Rev Cardiovasc Ther., 7(7):735-48.

Publication type: Research Support, Non-U.S. Gov't

Epidemiological, experimental studies and post hoc analyses of randomized trials suggested that n-3 polyunsaturated fatty acids (PUFA) and statins could be beneficial in chronic heart failure. Two double-blind, placebo-controlled, randomized clinical trials investigated the efficacy and safety of n-3 PUFA 1 g daily (R1) and rosuvastatin 10 mg daily (R2) in patients with heart failure. In total, 6975 and 4574 patients were randomized in R1 and R2, respectively; the main reason for excluding patients from R2 being the open-label administration of statin treatment. Primary end points were death, and death or admission to hospital for cardiovascular reasons. n-3 PUFA, but not rosuvastatin, significantly decreased the two coprimary end points: 56 and 44 patients needed to be treated with n-3 PUFA for a median duration of 3.9 years to avoid one death or one cumulative event. Both drugs were safe and were tolerated. A simple and safe treatment with n-3 PUFA provides a beneficial advantage in patients with heart failure in a context of usual care.