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A Comparison of Low Versus Standard Dose Pravastatin Therapy for the Prevention of Cardiovascular Events in the Elderly : The Pravastatin Anti-atherosclerosis Trial in the Elderly (PATE)

2001; Japan Atherosclerosis Society; Volume: 8; Issue: 2 Linguagem: Inglês

10.5551/jat1994.8.33

1880-3873

Hideki Ito, Yasuyoshi Ouchi, Yasuo Ohashi, Yasushi Saitō, Toshitsugu Ishikawa, Haruo Nakamura, Hajime Orimo,

Health Systems, Economic Evaluations, Quality of Life

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.