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Rosuvastatin granted EU licence for primary prevention

By Lilian Anekwe

The cholesterol-lowering drug rosuvastatin has been granted a European licence for the primary prevention of major cardiovascular events in high risk patients who do not have raised cholesterol levels.

The decision applies in 19 European countries including the UK, and means that while previously the drug was prescribed to lower LDL-cholesterol, GPs can now prescribe it to prevent CV events in high risk patients with a Framingham Risk of 20% or above – even if they do not have raised cholesterol or have not previously suffered a CV event.

The decision was made on the basis of results from a post-hoc analysis of the JUPITER study, which found that rosuvastatin 20mg significantly reduced the relative risk of stroke, heart attacks and arterial revascularisation in high risk patients.

The latest analysis of 6,000 patients aged 70 or over published in the Annals of Internal Medicine earlier this month, found that compared with those given placebo, patients receiving rosuvastatin had a 54% lower risk of heart attack, a 48% lower risk of stroke and 46% lower risk of arterial revascularisation.

The rates of the primary endpoint – heart attack, stroke, revascularisation, hospitalisation for angina or death from cardiovascular causes – occurred in 1.22 per 100 person years in the rosuvastatin group and 1.99 in the placebo group – a relative risk reduction on 39%.

Annals of Internal Medicine 2010;152:488-496.

Rosuvastatin has been granted a licence extension Rosuvastatin has been granted a licence extension