The findings from AstraZeneca’s Jupiter study, which show that Crestor demonstrated a dramatic risk reduction of cardiovascular death in people with low to normal cholesterol levels, could change the whole way statins are prescribed.

The landmark data, which were presented at the American Heart Association meeting in New Orleans and published online by the New England Journal of Medicine, show that Crestor (rosuvastatin) 20mg reduced the risk of cardiovascular death and heart attacks by 44% compared with patients on a placebo. The 17,802 participants in the JUPITER study were men over 50 and women over 60 who had elevated high-sensitivity levels of C-reactive protein but low to normal cholesterol levels, ie people who are not covered for treatment under current guidelines.

The JUPITER data also demonstrated that the combined risk of heart attack, stroke or CV death was reduced by 47%, while the risk of heart attack was cut by 54%. The risk of stroke was reduced by 48% and total mortality was cut by 20%.

AstraZeneca noted that on the basis of this data, if the results are projected over a period of five years, 25 patients would need to be treated to prevent one major CV event. Howard Hutchinson, the firm’s chief medical officer, said that "as is appropriate, the medical community, regulators, and guideline committees will now carefully consider these data and any implications for treating patients".

AstraZeneca expects to file a regulatory submission including the JUPITER data in the first half of 2009 and if approved, will begin promotional activities within the approved labelling. Crestor is not indicated for the prevention of cardiovascular events but if that approval was granted, its already strong sales (third-quarter revenues for the drug soared 28% to $922 million) would receive a massive boost.

The impressive data was somewhat expected given that JUPITER was stopped more than two years early by independent safety monitors because the benefit of Crestor 20mg was so pronounced.

The response to the data has been very positive in the main. "It takes prevention to a new level because it applies to a whole group of patients who would not get a statin today," said Douglas Weaver, president of the American College of cardiology, while lead study investigator Paul Ridker of Brigham and Women's Hospital in Boston said the observed benefits "are approximately twice as large as what doctors expect” when using statins in patients with high cholesterol".

Taking a more cautious stance, Mark Hlatky at Stanford University wrote in an editorial in the NEJM that the researchers need to extend the testing to other statins, including generics. He also said the findings did not indicate what level of CRP should be the threshold for treatment, nor did it answer questions about the potential risks of giving statins to people who are in relatively good health.

AstraZeneca chief executive David Brennan is hosting a teleconference later this morning to discuss JUPITOR and its impact on Crestor and indeed the whole company. Investors are certainly impressed and AstraZeneca shares were up 4% at £27.91 at 11am UK time.