(Circulation. 1995;91:2528-2540.)
© 1995 American Heart Association, Inc.
Articles |
Effects of Lipid Lowering by Pravastatin on Progression and Regression of Coronary Artery Disease in Symptomatic Men With Normal to Moderately Elevated Serum Cholesterol Levels
The Regression Growth Evaluation Statin Study (REGRESS)
From the Department of Cardiology (J.W.J., A.V.G.B.) and Department of Diagnostic Radiology and Nuclear Medicine (J.H.C.R.), University Hospital, Leiden; Department of Cardiology, University Hospital, Groningen (A.J.v.B., K.I.L.); St Antonius Hospital, Nieuwegein (E.T.B.); Department of Medical Statistics, Leiden University (A.H.Z.); SCOR Laboratory for Lipid Research, Erasmus University, Rotterdam (H.J.); CORE Laboratory for Lipid Analysis, Lipid Reference Laboratory, University Hospital "Dijkzigt," Rotterdam (G.J.M.B.); and Interuniversity Cardiology Institute, Utrecht (F.M.v.R.), Netherlands.
Correspondence to Albert V.G. Bruschke, MD, Department of Cardiology, Bldg I, C5-P, University Hospital Leiden, Rijnsburgerweg 10, 2333 AA Leiden, Netherlands.
Background Intensive lowering of serum cholesterol may retard progression of coronary atherosclerosis in selected groups of patients. However, few data are available on the potential benefit of serum cholesterol reduction in the broad range of patients with coronary atherosclerosis and normal to moderately elevated serum cholesterol levels who undergo various forms of treatment. The Regression Growth Evaluation Statin Study (REGRESS) addresses this group of patients.
Methods and Results REGRESS is a double-blind, placebo-controlled multicenter study to assess the effects of 2 years of treatment with the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor pravastatin on progression and regression of coronary atherosclerosis in 885 male patients with a serum cholesterol level between 4 and 8 mmol/L (155 and 310 mg/dL) by quantitative coronary arteriography. Primary end points were (1) change in average mean segment diameter per patient and (2) change in average minimum obstruction diameter per patient. Clinical events were also analyzed. Of the 885 patients, 778 (88%) had an evaluable final angiogram. Mean segment diameter decreased 0.10 mm in the placebo group versus 0.06 mm in the pravastatin group (P=.019): The mean difference between treatment groups was 0.04 mm, with a 95% CI of 0.01 to 0.07 mm. The median minimum obstruction diameter decreased 0.09 mm in the placebo group versus 0.03 mm in the pravastatin group (P=.001): The difference of the medians between the treatment groups was 0.06 mm, with a CI of 0.02 to 0.08 mm. At the end of the follow-up period, 89% (CI, 86% to 92%) of the pravastatin patients and 81% (CI, 77% to 85%) of the placebo patients were without new cardiovascular events (P=.002).
Conclusions In symptomatic men with significant coronary atherosclerosis and normal to moderately elevated serum cholesterol, less progression of coronary atherosclerosis and fewer new cardiovascular events were observed in the group of patients treated with pravastatin than in the placebo group.
Key Words: lipids • coronary disease • pravastatin • atherosclerosis • clinical trials
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