This pooled analysis of 30 completed clinical trials assessed the efficacy and safety of fluvastatin in patients <65 (n = 8,037) and patients > or =65 years of age (n = 3,717). The results demonstrated that in patients > or =65 years of age, lipid changes with fluvastatin therapy are equivalent to or slightly better than those observed in patients <65 years of age. Treatment with fluvastatin produced a significantly lower incidence of major cardiovascular clinical end points (major adverse cardiac events [MACEs]) and an increase in the time to a first MACE in the older population. The incidence of adverse events, particularly those of concern with statin therapy, was similar between the placebo- and fluvastatin-treated patients and between the different age groups. In conclusion, data derived from the pooled analysis with fluvastatin demonstrate that cardiovascular events are reduced in older high-risk patients to a greater extent compared with younger patients. Furthermore, this pooled analysis supports the use of fluvastatin to lower cholesterol levels in older high-risk patients.