Design, rational, and baseline characteristics of the Prospective Pravastatin Pooling (PPP) project--a combined analysis of three large-scale randomized trials: Long-term Intervention with Pravastatin in Ischemic Disease (LIPID), Cholesterol and Recurrent Events (CARE), and West of Scotland Coronary Prevention Study (WOSCOPS).

The Prospective Pravastatin Pooling (PPP) project is a pooled evaluation of 3 large, placebo-controlled, randomized trials of cholesterol-lowering treatment with pravastatin. It is designed to more reliably evaluate the effect of treatment on coronary and all-cause mortality and on total coronary artery disease (CAD) events for specific populations of interest, including women and the elderly. The trials--Long-Term Intervention With Pravastatin in Ischemic Disease trial, the Cholesterol and Recurrent Events trial, and the West of Scotland Coronary Prevention Study--each have common design features, including drug, dose, and duration. The project prospectively defines the objectives, end points, and analytic plans in a protocol developed before results are known of any individual trial. More than 2,000 (or 10%) of the participants in the pooled data set are women, 1,841 are aged > or = 70 years at trial entry, and > 6,000 have a total cholesterol < 5.5 mmol/L (213 mg/dl). The mean low-density lipoprotein cholesterol level is 4.2 mmol/L (162 mg/dl). The mean blood pressure level is 134/81 mm Hg and 20% are current smokers. Half of the PPP participants have had a prior myocardial infarction. More than 7% have a history of diabetes and 26% have a history of hypertension. PPP is projected to have data on about 1,100 CAD deaths, 500 non-CAD deaths, and > 1,000 cancers by study completion.(ABSTRACT TRUNCATED AT 250 WORDS)