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Major statins trial finds minimal heart failure benefit

The first trial to directly measure the benefits of statins in heart failure patients has bucked the trend of the ‘statins for all' movement.

Rosuvastatin had no effect on the number of deaths from cardiovascular causes, or non-fatal heart attacks and strokes, according to research presented at the American Heart Association annual scientific conference this week.

Researchers found no differences in outcomes in 5,011 heart failure patients aged 60 and over, who were treated with either daily rosuvastatin 10mg or a placebo.

Some 27.5% of patients in the rosuvastatin group either died or suffered a non-fatal cardiac event, compared with 29.3% in the placebo group; a non-significant 8% difference.

But rosuvastatin did have positive effects on LDL and HDL cholesterol levels, and fewer patients on rosuvastatin (2,193) were hospitalised than in the placebo group (2,564) during the follow-up period of nearly three years.

Lead researcher Dr John Kjekshus, head of the department of cardiology at the University of Oslo, told delegates that overall, statins had a neutral effect in elderly heart failure patients.

But he added: ‘It's important to bear in mind that these patients were really very old and very sick. We saw similar benefits in this group of patients as have been seen with other statin trials. Is an 8% benefit bad or good? Where do you draw the line of benefit?'

In an editorial published in the New England Journal of Medicine, Dr Frederick Masoudi, assistant professor of medicine at the University of Colorado at Denver, wrote:

‘Statins may have less incremental benefit in a population of older patients who are at risk for competing events, which could reduce the likelihood of ascertaining a benefit for specific cardiovascular outcomes.'

Dr Gordon Tomaselli, professor of medicine at the John Hopkins University in Baltimore, said there was ‘no reason to stop a statin if a patient developed heart failure.

‘I would still prescribe a statin under the right circumstances. If a patient is younger or has already been put on a statin I certainly would not stop if a patient progressed to heart failure, or left ventricular dysfunction.'

Patients were only eligible for the trial if they were not using or in need of cholesterol-lowering drugs, which experts said raised possible ethical issues of given statins ‘needlessly'.

Dr Kjekshus dismissed the concerns, saying: ‘It was extremely safe, even in these older patients you are not causing them harm if you prescribe them a statin. So I don't think it poses an ethical question.'

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