The present study involved a detailed post hoc comparison of the efficacy and safety of lipid-lowering therapy in elderly hypercholesterolemic patients from the Fukuoka Atherosclerosis Trial (FAST). The FAST cohort of 246 hypercholesterolemic patients included 76 patients who were (75 years old. Patients were randomized to receive probucol (500 mg/day) or pravastatin (10 mg/day) therapy, or to a control group (diet alone), and then were followed for 2 years. In patients > or = 75 years old, either probucol or pravastatin achieved a significant reduction of carotid intima-media thickness (IMT). In patients <75 years old, lipid-lowering therapy also achieved a significant reduction of IMT. In patients > or = 75 years old receiving probucol, the relative risk (95% confidence interval) of all-cause mortality was 0.15 (0.02 to 1.28) and that for major coronary events was 0.12 (0.02 to 1.04). In conclusion, probucol reduced the incidence of cardiovascular disease in elderly hypercholesterolemic patients as well as younger patients.