EFFECTS OF FLUVASTATIN ON CORONARY ATHEROSCLEROSIS IN PATIENTS WITH MILD-TO-MODERATE CHOLESTEROL ELEVATIONS (LIPOPROTEIN AND CORONARY ATHEROSCLEROSIS STUDY [LCAS])

Despite the potential for reduced morbidity and mortality, aggressive intervention against mild to moderate hypercholesterolemia in patients with coronary heart disease (CHD) remains controversial and infrequen tly practiced. Eligible patients in the 2.5-year Lipoprotein and Coron ary Atherosclerosis Study were men and women aged 35 to 75 years with angiographic CHD and mean low-density lipoprotein (LDL) cholesterol of 115 to 190 mg/dl despite diet. Patients (n = 429; 19% women) were ran domized to fluvastatin 20 mg twice daily or placebo. One fourth of pat ients were also assigned open-label adjunctive cholestyramine up to 12 g/day because prerandomization LDL cholesterol remained greater than or equal to 160 mg/dl. The primary end point, assessed by quantitative coronary angiography, was within-patient perlesion change in minimum lumen diameter (MLD) of qualifying lesions. Across 2.5 years, mean LDL cholesterol was reduced by 23.9% in all fluvastatin patients (+/- cho lestyramine) (146 to 111 mg/dl) and by 22.5% in the fluvastatin only s ubgroup (137 to 106 mg/dl). Primary end point analysis (340 patients) showed significantly less lesion progression in all fluvastatin versus all placebo patients, Delta MLD -0.028 versus -0.100 mm (p <0.01), an d for fluvastatin alone versus placebo alone, Delta MLD -0.024 versus -0.094 mm (p <0.02). A consistent angiographic benefit with treatment was seen whether baseline LDL cholesterol was above or below 160 or 13 0 mg/dl. Beneficial trends with treatment were also consistently seen in clinical event rates but were not statistically significant. Thus, lipid lowering by fluvastatin in patients with mildly to moderately el evated LDL cholesterol significantly slowed CHD progression. (C) 1997 by Excerpta Medica, Inc.