Study found a small but significant reduction in deaths; parallel study on cholesterol-lowering statin found no beneficial effect.
SUNDAY, Aug. 31 (HealthDay News) -- Daily supplements of omega-3 polyunsaturated fatty acids -- the kind found in fish oil -- reduced deaths and hospitalizations of people with heart failure, an Italian study found.
But a cholesterol-lowering statin drug had no beneficial effect in a parallel heart failure trial.
"This confirms what we've been seeing for a couple of decades in observational studies," Dr. Dariush Mozaffarian, an associate professor of medicine and epidemiology at Harvard Medical School and the Harvard School of Public Health, said of the fish oil trial. "There is a benefit of omega-3 polyunsaturated fatty acids for heart failure patients."
Both findings were published online Aug. 31 in the journal The Lancet and presented at a meeting of the European Society of Cardiology, in Munich, Germany.
The omega-3 polyunsaturated fatty acid (PUFA) study, done by a consortium of 357 Italian cardiology centers, enlisted more than 7,000 people diagnosed with heart failure, which is the progressive loss of the heart's ability to pump blood. Half took a daily capsule containing omega-3 PUFA, the other half took a capsule with a placebo. The death rate in the PUFA group was 27 percent, compared to 29 percent in the placebo group.
That reduction might not seem like much, but it impressed Mozaffarian, who has done his own PUFA studies.
"There are few treatments we have in medicine that affect total mortality in patients," he said. "Just a handful of treatments affect total mortality. Even a small move percentage-wise is a very important effect."
In absolute terms, the Italian researchers reported that 56 people with heart failure would have to take PUFA supplements for about four years to avoid one death. The supplements also reduced hospitalizations, with one less hospitalization or death for every 44 people taking the supplements for four years.
Similar results have been reported in two earlier trials, Mozaffarian said. But they did not have the strict conditions of the Italian study, which were placebo-controlled and "double-blind," meaning that neither the physicians nor the participants knew who was getting the active substance rather than the placebo.
"You always like to have a placebo-controlled trial," he said.
But the positive trial results don't mean that anyone with heart failure can start taking fish oil supplements on their own, said Dr. Gregg Fonarow, professor of cardiovascular medicine at the University of California, Los Angeles, who wrote an editorial accompanying the journal report.
"They used a specific formulation, a prescription formulation," Fonarow said. "Heart failure is a very high-risk condition. It is absolutely critical for patients, whether it is a prescription medicine or modification of diet or a supplement, that they consult their physician."
The negative results of the statin trial were a surprise, Fonarow said. It included more than 4,500 people with heart failure, half of whom took the statin rosuvastatin (Crestor), while the other half took a placebo. The death rate was 29 percent in the statin group, 28 percent in the placebo group.
The result doesn't mean that a statin should not be prescribed for someone with heart failure and high cholesterol, Fonarow said. "There were no safety concerns," he said. "The drug was well tolerated. It indicates that heart failure, in and of itself, should not be reason to start a patient on a statin."
The study "doesn't shut the door" on the use of statins for heart failure, Mozaffarian said, "but it closes it partly. Maybe another statin would have a benefit. It definitely makes us question the benefit of statins in heart failure, but it doesn't close the door completely."
Another report in the same issue of the journal that was led by British cardiologists described a trial of the drug ivabradine, which reduces the heart rate, in people with coronary artery disease and an unusually fast heart rate. The drug reduced deaths and hospitalizations significantly, the researchers said.
Learn more about heart failure and its treatment from the American Heart Association.
SOURCES: Dariush Mozaffarian, M.D., associate professor of medicine, Harvard Medical School and Harvard School of Public Health, Boston; Gregg Fonarow, M.D., professor of cardiovascular medicine, University of California, Los Angeles; Aug. 31, 2008, European Society of Cardiology meeting, Munich, Germany; Aug. 31, 2008, The Lancet, online
All rights reserved