A simple and safe treatment with n-3 polyunsaturated fatty acids (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, according to the GISSI-HF trial in the Oct. 4 issue of the Lancet.
The Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico-heart failure (GISSI-HF) study group in Italy, undertook a randomized, double-blind, placebo-controlled trial in 326 cardiology and 31 internal medicine centers in Italy. They enrolled patients with chronic heart failure, irrespective of cause and left ventricular ejection fraction, and randomly assigned them to n-3 PUFA 1 g daily (3,494) or placebo (3,481). Patient follow up was for a median of 3.9 years.
The group found that 27 percent of patients died from any cause in the n-3 PUFA group and 29 percent in the placebo group.
According to the authors, 57 percent of patients in the n-3 PUFA group and 59 percent in the placebo group died or were admitted to hospital for cardiovascular reasons. 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 (3 percent in both group).
“Although this moderate benefit was smaller than was expected, we should note that it was obtained in a population already treated with recommended therapies, was consistent across all the predefined subgroups, and was further supported by the findings of the per-protocol analysis. We noted no adverse effects in the population of symptomatic patients with heart failure in whom the n-3 PUFA had never been tested, confirming the safety of the drug,” the authors wrote.
Società Prodotti Antibiotici, Pfizer, Sigma Tau and AstraZeneca funded the study.