Design and baseline characteristics of a study of primary prevention of coronary events with pravastatin among Japanese with mildly elevated cholesterol levels

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.