Abstract
REGRESS is a double blind, placebo controlled multicenter study to assess the effect of 2 year treatment with pravastatin 40 mg once daily on pro- and regression of angiographically documented coronary artery disease in 885 patients with a serum cholesterol between 4–8 mmol/l (155 and 310 mg/dl). The REGRESS study comprises three blocks of patients: a percutaneous coronary angioplasty, a coronary artery bypass grafting and a medical management group. Analysis of baseline and follow-up coronary arteriograms was performed visually and by quantitative computer analysis (QCA). Primary endpoints were QCA assessments of 1. change in Mean Segment Diameter (MSD) averaged per patient and 2. change in Minimum Obstruction Diameter (MOD) averaged per patient. 778 patients (88%) of the patients had an evaluable final angiogram. Mean Segment Diameter decreased with 0.10 mm in the placebo group versus 0.06 mm in the pravastatin group (p = 0.019): the mean difference between treatment groups was 0.04 mm with 95% confidence interval (ci) of 0.01–0.07 mm. The median Minimum Obstruction Diameter decreased with 0.09 mm in the placebo group versus 0.03 mm in the pravastatin group (p = 0.001): the difference of the medians between the treatment groups was 0.06 mm with ci of 0.02–0.08 mm. At the end of the follow-up period 89% (ci 86–92%) of the pravastatin patients and 81% (ci 77–85%) of the placebo patients were without new cardiovascular events (p = 0.002). in symptomatic men with normal or moderately raised serum cholesterol, pravastatin slows progression of coronary atherosclerosis and reduces the number of cardiovascular events.
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