Abstract
Treatment with low drug doses is generally recommended in the elderly. However, the efficacy of low-dose 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitor treatment in elderly hypercholesterolemic patients has never been examined. Therefore, we compared the effect of low-dose with standard-dose pravastatin, an HMG CoA reductase inhibitor, on the incidence of cardiovascular events (CVEs) in elderly patients with hypercholesterolemia in a randomized prospective trial. Subjects aged ≥60 years (73±6 years) with serum total cholesterol (TC) levels of 220-280 mg/dL were randomized to the low-dose (group L, 5 mg/day ; n= 334) or standard-dose (group S, 10-20 mg/day ; n=331). Baseline TC levels were similar in the 2 groups (253±15 mg/dL). Patients were followed for 3-5 years (mean 3.9 years). TC levels decreased from baseline by 11-13% in group L and by 15-17% in group S. TC levels at 1 year in S and L group were 209±2 mg/dL (16±1% decrease) and 221±2 mg/dL (12±1% decrease), respectively. Forty-two and 29 CVEs occurred in group L and S, respectively. The incidence of CVEs was significantly lower in group S than in group L (P=0.046, generalized Wilcoxon test ; P=0.096, log-rank test). The risk ratio for group S compared with group L was 0.674 (95% confidence interval : 0.423-1.074). Subgroup analyses suggested that the difference in the incidence of CVEs between the 2 groups was more clear in subjects without diabetes mellitus, with TC levels of <253 mg/dL, and with TG levels of ≥133 mg/dL. The incidence of CVEs in group S was significantly lower than that in group L in subjects without both diabetes mellitus and previous cardiovascular disease (P=0.026, generalized Wilcoxon test ; P=0.032, log-rank test). These findings suggest that standard-dose pravastatin (10-20 mg/day) is more effective in reducing the incidence of CVEs in the elderly than low-dose pravastatin (5 mg/day), especially in nondiabetic elderly patients with mild hypercholesterolemia or previous cardiovascular disease. J Atheroscler Thromb, 2001 ; 8 : 33-44.
