A simple, 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, while statin treatment with rosuvastatin had no effect in patients with chronic heart failure, according to two studies based on the GISSI-HF trial presented at the European Society of Cardiology (ESC) congress in Munich, Germany.
Both studies from the GISSI-HF (Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto miocardico- Heart Failure) trial were published online in the Aug. 31 issue of the Lancet.
In the first study, Luigi Tavazzi, MD and Gianni Tognoni, MD, from the GISSI-HF Coordinating Centre, ANMCO Research Center in Florence, Italy, and Mario Negri Institute in Milan, Italy, and colleagues discussed the results of a randomized controlled trial, which examined patients with chronic heart failure from 357 cardiology sites in Italy.
The patients received either omega-3 PUFA in a capsule once daily (3,494 patients) or placebo (3,481), according to the researchers. Of the groups, 27 percent in the PUFA group died, compared with 29 percent in the placebo group, indicating a relative risk reduction of 9 percent in the PUFA group.
The investigators reported that a higher proportion of patients in the placebo group (59 percent) died or were admitted to hospital for cardiovascular reasons than in the PUFA group (57 percent) — a relative reduction of 8 percent in the PUFA group.
The authors wrote that 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 percent of patients in both groups.
“Our study shows that the long-term administration of 1 g per day omega-3 PUFA was effective in reducing both all-cause mortality and admissions to hospital for cardiovascular reasons,” the authors concluded.
In the second study based on GISSI-HF, the same authors discussed the results of a randomized controlled trial that examined the effect of the statin drug rosuvastatin (AstraZeneca’s Crestor) in patients with heart failure. Patients received either rosuvastatin 10 mg daily (2,285 patients) or placebo (2,289 patients), and were followed for a median of nearly four years from the same 357 cardiology sites in Italy.
The researchers found that 29 percent died from any cause in the rosuvastatin group, compared with 28 percent in the placebo group. Proportions of patients who died or were admitted to hospital for cardiovascular causes were also similar in both groups (57 percent rosuvastatin vs. 56 percent placebo).
Again, gastrointestinal disorders were the most common adverse events in both groups (1 percent rosuvastatin vs. 2 percent placebo).
“Rosuvastatin 10 mg daily did not affect clinical outcomes in patients with chronic heart failure of any cause, in whom the drug was safe,” the authors concluded.
“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,” said Gregg Fonarow, MD, from Ahmanson-UCLA Cardiomyopathy Center in Los Angeles in an accompanying Lancet commentary.