A simple, safe, one-a-day capsule of omega-3 polyunsaturated fatty acids (PUFA) can reduce mortality and admission to hospital for cardiovascular reasons in patients with heart failure. These are the conclusions of the first of two Articles based on the GISSI-HF* study published early Online and in an upcoming edition of The Lancet. The second Article concludes that statin treatment with rosuvastatin does not affect clinical outcomes in patients with chronic heart failure. Both Articles are being presented at the European Society of Cardiology meeting in Munich.
In the first Article Professor Luigi Tavazzi and Professor Gianni Tognoni , GISSI-HF Coordinating Centre, ANMCO Research Centre, Florence, Italy and Mario Negri Institute, Milan, Italy and colleagues from the GISSI-HF investigators discuss the results of a randomised controlled trial from 357 cardiology sites in Italy, which looked at patients with chronic heart failure. Patients received either omega-3 PUFA in a capsule once daily (3494 patients) or placebo (3481). 955 patients in the PUFA group (27%) died, compared with 1014 (29%) in the placebo group – meaning a relative risk reduction of 9% in the PUFA group. A higher proportion of patients in the placebo group (2053 / 59%) died or were admitted to hospital for cardiovascular reasons than in the PUFA group (1981 / 57%) — a relative reduction of 8% in the PUFA group. In absolute terms, 56 patients needed to be treated with PUFA for just under four years to avoid one death, or 44 patients to avoid one event of either death or admission to hospital for cardiovascular causes. Gastrointestinal disorders were the most frequent adverse reaction, and were experienced by 3% of patients in both groups. The authors conclude: "Our study shows that the long-term administration of 1g per day omega-3 PUFA was effective in reducing both all-cause mortality and admissions to hospital for cardiovascular reasons."
The second Article based on GISSI-HF, by the same authors, discusses the results of a randomised controlled trial from the same 357 cardiology sites in Italy, which looked at the effect of the statin drug rosuvastatin in patients with heart failure. Patients received either rosuvastatin 10mg daily (2285 patients) or placebo (2289), and were followed up for a median of nearly four years. The researchers found that 657 patients (29%) died from any cause in the rosuvastatin group, compared with 644 (28%) in the placebo group. Proportions of patients who died or were admitted to hospital for cardiovascular causes were also similar in both groups (1305/57% rosuvastatin versus 1283/56% placebo). Again, gastrointestinal disorders were the most common adverse events in both groups (1% rosuvastatin versus 2% placebo). The authors conclude: "Rosuvastatin 10mg daily did not affect clinical outcomes in patients with chronic heart failure of any cause, in whom the drug was safe."
In an accompanying Comment, Dr Gregg Fonarow, Ahmanson-UCLA Cardiomyopathy Center, Los Angeles, CA, USA, says: "For omega-3 fatty acid supplementation, benefits observed in other populations apply to patients with heart failure. For statins, the benefits, unfortunately, seem not to. Although other promising treatments for heart failure are under investigation, every effort should be made apply those therapies which are evidence-based to all eligible patients with heart failure."
Note to editors:
*GISSI-HF stands for Gruppo Italiano di Studio della Sopravvivenza nella Insufficienza cardiaca- Heart Failure
Professor Luigi Tavazzi, GISSI-HF Coordinating Centre, ANMCO Research Centre, Florence, Italy and Mario Negri Institute, Milan, Italy T) mobile +39-334-7624321, office +39-0545-7624321, ltavazzi@gvm-vmc.it
Gianni Tognoni, Mario Negri Institute, Milan, Italy, mobile +39-347-1824914, phone +39-0872-570303, tognoni@negrisud.it
Professor Aldo P Maggioni GISSI-HF Coordinating Centre, ANMCO Research Centre, Florence, Italy and Mario Negri Institute, Milan, Italy T) mobile +39-335-258338, office +39-055-5101228, maggioni@anmco.i t
Dr Gregg Fonarow, Ahmanson-UCLA Cardiomyopathy Center, Los Angeles, CA, USA T) +1 310 948-2822 E) gfonarow@mednet.ucla.edu
full study: http://press.thelancet.com/escgissi.pdf
The Lancet