Chicago, IL - Rosuvastatin gained clinical traction today with the announcement that a large event-driven study was stopped early because the lipid-lowering agent was shown to be more beneficial than placebo in reducing cardiovascular morbidity and mortality [1].

The study is known as the Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER), a large, multinational, long-term, double-blind, placebo-controlled, randomized clinical trial designed to assess directly whether statin therapy (rosuvastatin 20 mg/day) should be given to apparently healthy individuals with low LDL-cholesterol levels but elevated C-reactive-protein (CRP) levels.

The halting of JUPITER was announced in the wake of the presentation of the disappointing results of the Effect of Combination Ezetimibe and High-Dose Simvastatin vs Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) study and an American College of Cardiology consensus panel that urged physicians to prescribe statin medications with proven clinical effectiveness. AstraZeneca issued a press release saying the independent data monitoring board observed "unequivocal evidence of a reduction in cardiovascular morbidity and mortality" among those treated with rosuvastatin compared with placebo.

In total, the trial included 15 000 males aged 50 years and older and females aged 60 years and older with no history of MI, stroke, or arterial revascularisation and LDL-cholesterol levels <130 mg/dL. Patients were considered at risk for coronary heart disease on the basis on their elevated CRP levels. The lead investigator of JUPITER is Dr Paul Ridker (Brigham and Women's Hospital, Boston, MA).

Dr Steven Nissen (Cleveland Clinic, OH), who conducted a study showing that intensive lipid lowering with rosuvastatin resulted in a significant regression of coronary atherosclerosis as measured by intravascular ultrasound (IVUS), said little is known about the stopping of JUPITER, but the results are good news for statins.

"Now, for every single statin, we have clinical-outcomes data," he told heartwire. "If that doesn't tell you that it's a class effect, then I don't know what does. In the wake of ENHANCE, it's obviously important, because if we're not going to use ezetimibe to get patients to low LDL levels we've got to use something, and potent statins certainly do work."

Dr Christie Ballantyne (Baylor College of Medicine, Houston, TX) said that the surrogate-outcomes data—the reduction in LDL-cholesterol levels, the effects of rosuvastatin on IVUS end points, as well as new data showing an effect of rosuvastatin on diameter stenoses as measured by quantitative coronary angiography—and the outcomes data are beginning to line up.

Source: AstraZeneca. Crestor outcomes study JUPITER closes early due to unequivocal evidence of benefit [AstraZeneca press release]. March 31, 2008