The JUPITER study ended more than 2 years early after an "unequivocal benefit of rosuvastatin" was determined among individuals with normal cholesterol levels but elevated levels of high-sensitivity C-reactive protein.
The number of patients taking cholesterol-lowering statins may rise in the future, in light of results of a late-breaking, large-scale clinical trial released last week at the American Heart Association (AHA) Scientific Sessions in New Orleans.
The study found that patients with normal cholesterol levels, no history of cardiovascular disease (CVD), but elevated levels of high-sensitivity C-reactive protein (hs-CRP) who took the lipid-lowering drug rosuvastatin (Crestor) had a much lower risk of heart attacks and stroke. The randomized, double-blind study (known as the JUPITER trial) involved 17,802 men aged >50 years and women >60 with elevated hs-CRP levels. Those taking rosuvastatin had a 54% reduction in heart attacks, a 48% reduction in stroke, and a 46% reduction in the need for interventions to reopen blocked blood vessels, compared with those who received placebo.
“Not only do we confirm that apparently healthy men and women with elevated hs-CRP are at high risk for cardiovascular events, but we demonstrate that a simple therapy can reduce their risk of heart attack, stroke, or cardiovascular death,” noted Paul Ridker, MD, lead author of the study.
Study participants were recruited from 1300 clinical sites in 26 countries and randomly assigned 20 mg of rosuvastatin a day or a daily placebo. The trial ended in March 2008—more than 2 years ahead of schedule—when it was determined that the data indicated “unequivocal benefit of rosuvastatin” on coronary-related death and disability.
Two other studies, presented at the AHA meetings and supported by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health, also provide evidence that hs-CRP is a useful marker for CVD. “These findings suggest that adding hs-CRP levels to traditional risk factors could identify millions more adults for whom treatment with statins appears to lower the risk of heart attack,” said NHLBI Director Elizabeth Nabel, MD.
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