Statin trial stopped after success

The Jupiter trial investigated the effects of rosuvastatin on almost 18,000 patients with low to normal cholesterol levels but raised concentrations of an inflammation protein.

Under normal circumstances, the patients would not be considered at risk of suffering a heart attack, stroke, or dying from a heart-related cause. Yet those receiving medium doses of the drug, sold under the brand name Crestor, experienced far fewer adverse heart events than those given a non-active placebo.

Heart attack risk was reduced by 54% and stroke by 48%. The combined risk of heart attack, stroke and heart-related death fell by by 47%, as did the odds of undergoing surgical procedures. Because the benefits were so clear, an independent monitoring board halted the trial more than six months early last March.

Patients, recruited from 26 countries, were typically monitored for 1.9 years instead of three and a half as originally planned. All were apparently healthy, but all had high levels of C-reactive protein (CRP), an inflammation marker believed to be linked to heart disease.

A British arm of the study, led by Professor James Shepherd from the University of Glasgow, contributed more than 16% of the study participants. Writing in the New England Journal of Medicine, the researchers pointed out that recruiting patients with elevated CRP made a big difference to the results.

Previous statin trials have generally focused on elevated "bad" low-density lipoprotein (LDL) cholesterol. Their results led scientists conducting the new trial to expect a modest fall of about 25% in the number of adverse heart events.

But the effect they saw was much greater. The researchers, led by Dr Paul Ridker, from Harvard Medical School in Boston, US, reported: "The reduction in the hazard seen in our trial, in which enrolment was based on elevated high-sensitivity C-reactive protein levels rather than on elevated LDL cholesterol levels, was almost twice this magnitude and revealed a greater relative benefit than that found in most previous statin trials."

Rosuvastatin was "highly effective" at reducing levels both of cholesterol and C-reactive protein, said the researchers. The study highlighted the role inflammation played in heart and artery disease. The results were in a journal and were presented at the American Heart Association's Scientific Sessions meeting.

The trial was funded by the pharmaceutical company AstraZeneca, which manufactures Crestor. However, the company played no part in the data analysis or drafting of the paper, and did not have access to any results until the study was submitted for publication.