Circulation Journal
Online ISSN : 1347-4820
Print ISSN : 1346-9843
ISSN-L : 1346-9843
Clinical Investigation
Design and Baseline Characteristics of a Study of Primary Prevention of Coronary Events With Pravastatin Among Japanese With Mildly Elevated Cholesterol Levels
Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese (MEGA) Study Group
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2004 Volume 68 Issue 9 Pages 860-867

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Abstract

Background Although cholesterol management reportedly reduces fatal and non-fatal coronary heart disease (CHD) events in subjects with or without evident atherosclerotic disease, it is still uncertain whether these benefits extend to Japanese. Methods and Results The study group comprised 8,009 subjects with mildly elevated total cholesterol who were randomized to treatment with 10-20 mg pravastatin plus diet (2,691 women, 1,267 men) or diet alone (2,758 women, 1,293 men). The groups were extremely well balanced with respect to baseline demographics and risk factors such as blood pressure and plasma lipids. Over a 5-year period of follow-up, the primary end-points will be a composite of fatal and non-fatal coronary events. Secondary end-points will include stroke and transient ischemic attack, all cardiovascular events and total mortality. Conclusions The 2 groups will be followed up until the end of March 2004 and end-points will be analyzed by full analysis set. (Circ J 2004; 68: 860 - 867)

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© 2004 THE JAPANESE CIRCULATION SOCIETY
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