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Introduction
Previous trials of HMG Co-A reductase inhibitors [1–5] have focused primarily on subjects under the age of 70 years. The PROspective Study of Pravastatin in the Elderly at Risk (PROSPER) is a randomised, double blind, placebo-controlled trial to test the hypothesis that treatment with pravastatin will diminish the risk of subsequent major vascular events in a cohort of high-risk elderly individuals with a wide range of cholesterol levels. The primary endpoint is the composite outcome of coronary heart disease death, non-fatal myocardial infarction, and fatal or non-fatal stroke. This report describes the outcome of study recruitment, the baseline characteristics of the randomised subjects, and contrasts the randomised subjects with the total population of screenees.
Methods
Overview of study design and data acquisition
The study has been described in detail elsewhere [6]. Briefly, PROSPER is designed to examine the benefits of pravastatin (40 mg per day) versus placebo in 70–82 year old men and women with either pre-existing vascular disease or elevated risk of such disease due to smoking, hypertension, or diabetes. Age-eligible individuals in the primary care setting were invited to attend an initial screening visit (S1) conducted by a study nurse, at which consent for the screening process, a brief medical history, and vital signs were recorded, and dietary and appropriate health advice given. Data recorded included standard risk factors such as age, sex, blood pressure, heart rate, body mass index, history of hypertension, diabetes, smoking, and vascular disease. At subsequent visits prior to randomisation, these data were recorded again, along with alcohol consumption (measured in units/week, with one unit being equivalent to one glass of wine, one half pint of beer or one standard measure of spirits), current medication use, and details of previous major illnesses and ongoing chronic conditions. In Scotland and Ireland, the subjects were invited in an unselected manner. In the Netherlands, however, subjects were pre-selected on the basis of possession of previously known cardiovascular risk factors. Subjects who continued to be eligible after screening were invited to a second screening visit (S2), at which a more detailed medical history was taken and a fasting venous blood sample drawn for biochemical and hematological checks and lipoprotein quantification. If, on the basis of their blood results, subjects were still eligible...