EFFICACY AND SAFETY OF PRAVASTATIN IN THE LONG-TERM TREATMENT OF ELDERLY PATIENTS WITH HYPERCHOLESTEROLEMIA

PURPOSE: Elevated cholesterol levels are a major risk factor for coron ary heart disease, which remains a significant problem in patients bey ond age 65 years. Because drug therapy for the control of hypercholest erolemia in elderly patients is frequently considered to be indicated, we investigated the efficacy and safety of pravastatin in the treatme nt of elderly subjects with primary hypercholesterolemia. PATIENTS AND METHODS: In this 96-week, multicenter, double-blind, placebo-controll ed study, 142 subjects (95 women, 47 men) 64 to 90 years of age with e levated cholesterol levels despite dietary intervention were randomize d to receive pravastatin 20 mg at bedtime or matching placebo (2:1). D osage could be doubled after 8 weeks, a bile acid-binding resin could be added after 16 weeks, and nicotinic acid or probucol could be added after 32 weeks, as needed, to adequately lower the low-density lipopr otein cholesterol (LDL-C) levels. RESULTS: Significant reductions in t he levels of LDL-C (-30.9%), total cholesterol (Total-C; -21.9%), and triglycerides (TG; -16.7%) and significant increases in the levels of high-density lipoprotein cholesterol (HDL-C; 11.3%) were noted in the group receiving pravastatin treatment at 16 weeks (P less than or equa l to 0.001 compared with baseline, P less than or equal to.0.01 compar ed with placebo). The cholesterol-lowering effects of pravastatin were sustained throughout the 96 weeks of the trial. Pravastatin was well tolerated, with an overall incidence of adverse events nearly identica l to that of placebo. CONCLUSIONS: In this study, pravastatin was well tolerated and effective in lowering LDL-C, Total-C, and TG and in rai sing HDL-C during long-term treatment of elderly patients with primary hypercholesterolemia.