Rosuvastatin trial halted early amid fears for placebo group

Primary prevention statin trial gives poor outcome for controls.

A study into the use of rosuvastatin for the primary prevention of cardiovascular disease (CVD) has been stopped due to overwhelming efficacy.

It was found to be more beneficial than placebo at reducing cardiovascular morbidity and mortality, claim US researchers.

The JUPITER study began in 2003 and involved 15,000 patients, aged at least 50, who had no history of MI, stroke or arterial revascularisation and had LDL cholesterol levels below 120mg/dl. They were randomly assigned to receive either 20 mg rosuvastatin daily or placebo.

But last week, the study was halted as it had become clear that participants given placebo had an increased risk of CVD events and death.

Dr John Pittard, a member of the Primary Care Cardiovascular Society and a GP in Surrey, said: 'The findings of the trial suggest that rosuvastatin is effective at lowering CVD risk.

It is unsurprising the trial was stopped early because there is a need to protect those in the placebo group, added Dr Pittard.

'It is, however, scientifically correct and ethical to test a drug against a placebo rather than perform a head-to-head study,' he said. 'But perhaps a third treatment arm involving another statin could have been added to the trial.'

Berkshire GP Dr George Kassianos, a member of the British Cardiology Society, said: 'This is an excellent outcome study for the use of rosuvastatin. It is much more difficult to show outcomes in primary than secondary prevention.'

Results of the JUPITER trial are still to be published.

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