Statin approved for primary CV prevention

THE first statin has been approved for primary cardiovascular prevention in Australia, despite controversy over clinical trial results underlying the indication. 

AstraZeneca, maker of rosuvastatin (Crestor), announced last week the drug had received an indication for prevention of major cardiovascular events in men 50 years or older, and women 60 years or older, with no clinically evident CVD but with at least two conventional risk factors.

The new indication is based on the findings of the JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) study in around 17,000 people, published in 2008. It showed that 20 mg of rosuvastatin daily reduced major cardiovascular events by 44% compared with placebo after nearly two years.

The trial was stopped early due to the benefit. 

The results were widely criticised because the controversial high-sensitivity C-reactive protein (CRP) test was used to screen people for trial entry (MO, 14 Nov 2008).

Associate Professor David Sullivan, head of the CV health clinic at Sydney’s Royal Prince Alfred Hospital, said he was “relieved” the new indication was granted for rosuvastatin.

“I thought for a while that things were going to get tied up in the requirement for measurement of high-sensitivity CRP, which could have led to a less appropriate use of statins,” he said.

However, Associate Professor Leon Simons, head of the cholesterol clinic at Sydney’s St Vincent’s Hospital, said it would still be advisable to perform a calculation of absolute CVD risk.