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)

Background Intensive lowering of serum cholesterol may retard progress ion of coronary atherosclerosis in selected groups of patients. Howeve r, few data are available on the potential benefit of serum cholestero l reduction in the broad range of patients with coronary atheroscleros is and normal to moderately elevated serum cholesterol levels who unde rgo various forms of treatment. The Regression Growth Evaluation Stati n Study (REGRESS) addresses this group of patients. Methods and Result s REGRESS is a double-blind, placebo-controlled multicenter study to a ssess the effects of 2 years of treatment with the 3-hydroxy-3-methylg lutaryl coenzyme A reductase inhibitor pravastatin on progression and regression of coronary atherosclerosis in 885 male patients with a ser um cholesterol level between 4 and 8 mmol/L (155 and 310 mg/dL) by qua ntitative coronary arteriography. Primary end points were (1) change i n average mean segment diameter per patient and (2) change in average minimum obstruction diameter per patient. Clinical events were also an alyzed. Of the 885 patients, 778 (88%) had an evaluable final angiogra m. Mean segment diameter decreased 0.10 mm in the placebo group versus 0.06 mm in the pravastatin group (P=.019): The mean difference betwee n 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 g roup 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 9 2%) of the pravastatin patients and 81% (CI, 77% to 85%) of the placeb o patients were without new cardiovascular events (P=.002). Conclusion s In symptomatic men with significant coronary atherosclerosis and nor mal to moderately elevated serum cholesterol, less progression of coro nary atherosclerosis and fewer new cardiovascular events were observed in the group of patients treated with pravastatin than in the placebo group.