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Title: Rosuvastatin Reduces Cardiac Events in "Healthy" Patients With Low Low-Density Lipoprotein and High Levels of C-Reactive Protein: Presented at AHA

"Rosuvastatin Reduces Cardiac Events in "Healthy" Patients With Low Low-Density Lipoprotein and High Levels of C-Reactive Protein: Presented at AHA"

By Ed Susman NEW ORLEANS -- November 10, 2008 -- Treatment with cholesterol-lowering rosuvastatin significantly reduces coronary events -- including overall mortality -- among patients who are asymptomatic for heart disease but have high levels of high-sensitivity C-reactive protein and low levels of low-density lipoprotein (LDL) cholesterol when the treated subjects are compared with those on placebo. Results from the Justification for the Use of Statins in Prevention: an Interventional Trial Evaluating Rosuvastatin (JUPITER) trial were reported here at the American Heart Association (AHA) 2008 Scientific Sessions. Treatment with rosuvastatin 20 mg daily resulted in a lowering of LDL cholesterol by 50% compared with placebo and lowered C-reactive protein by 37%, said lead investigator Paul Ridker, MD, Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Boston, Massachusetts. The reported reduction resulted in a 44% decline in relative risk in the primary endpoint (the composite of myocardial infarction, stroke, arterial revascularisation, hospitalisation for unstable angina, or death from cardiovascular causes), Dr. Ridker said here on November 9, at a late-breaking oral presentation. The JUPITER results were simultaneously released in the online edition of the [New England Journal of Medicine (DOI: 10.1056/NEJMoa0807646).

JUPITER was stopped after a median follow-up of 1.9 years, when the independent data monitoring and safety board identified excess events occurring in the placebo arm. The study had been planned to continue for 5 years.

"Application of the simple screening and treatment strategy tested in the JUPITER trial over a 5-year period could conservatively prevent more than 250,000 heart attacks, strokes, revascularisation procedures, and deaths in the United States alone," Dr. Ridker noted.

In the JUPITER trial, researchers in 26 countries in North and South America, Europe, Asia, and Africa randomised 17,802 participants into one group of 8,901 subjects receiving rosuvastatin and compared them with a group of 8,901 subjects taking placebo.

When the study closed, Dr. Ridker said, the analysis found that there was a 54% relative reduction in MI (HR 0.46, 95% CI 0.30 to 0.70, P < .0002); a 48% relative reduction in fatal and nonfatal stroke (HR 0.52, 95% CI 0.34 to 0.79, P < 0.002); and a 47% relative reduction in need for arterial revascularization (HR 0.53, 95% CI 0.40 to 0.70, P < .00001).

On a precautionary note, patients on rosuvastatin had a higher incidence of physician-reported diabetes (3%) compared with those on placebo (2.4%) (P = .01). Dr. Ridker said similar findings for diabetes had been seen in other statin trials.

"The JUPITER study expands primary prevention considerably," stated Doug Weaver, MD, Henry Ford Hospital, Detroit, Michigan, who commented on the study during the presentation. He suggested that primary-care physicians, rather than cardiologists, would probably be the clinicians likely to order C-reactive protein testing for patients.

"If a patient fulfills the criteria -- a man aged over 50 years or a woman over 60 with no symptoms of heart disease and an LDL cholesterol level of less than 130 mg/dL -- a clinician might consider ordering a C-reactive protein test to determine if the level of this marker was elevated (>2 mg/L)," Dr. Weaver explained.

If it was elevated, he said, treatment with statin therapy could be initiated.

The JUPITER results indicated that there did not appear to be any safety issues with rosuvastatin; this finding, Dr. Ridker said, "should be reassuring to patients and doctors that these drugs, as a class, are highly effective in preventing what really matters."

Funding for this study was provided by AstraZeneca Pharmaceuticals LP.

[Presentation title: A Randomized Trial of Rosuvastatin in the Prevention of Cardiovascular Events Among 17,802 Apparently Healthy Men and Women With Elevated Levels of C-Reactive Protein (hsCRP): The JUPITER Trial.]

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