EFFECTS OF PRAVASTATIN IN PATIENTS WITH SERUM TOTAL CHOLESTEROL LEVELS FROM 5.2 TO 7.8 MMOL LITER (200 TO 300 MG DL) PLUS 2 ADDITIONAL ATHEROSCLEROTIC RISK-FACTORS

This placebo-controlled, multinational study evaluated the use of prav astatin in 1,062 patients with hypercholesterolemia (serum total chole sterol concentrations of 5.2 to 7.8 mmol/liter [200 to 300 mg.dl] and greater-than-or-equal-to additional risk factors for atherosclerotic c oronary artery disease. Efficacy and safety analyses were performed on the initial 26-week, randomized, double-blind, placebo-controlled per iod; further safety analyses were conducted on the subsequent 52 weeks , which included an additional 26-week double-blind phase permitting o ther lipid-lowering agents and a final 26-week open-label period. At 1 3 weeks, pravastatin at a dose of 20 mg once daily at bedtime signific antly lowered serum low-density lipoprotein cholesterol 26% (4.7 to 3. 5 mmol/liter [182 to 135 mg/dl]), total cholesterol 19% (6.8 to 5.6 mm ol/liter [263 to 217 mg/dl]) and triglycerides 12% (1.8 to 1.6 mmol/li ter [159 to 142 mg/dl]) (p < 0.001 compared with placebo) and signific antly raised serum high-density lipoprotein cholesterol 7% (1.1 to 1.2 mmol/liter [43 to 46 mg/dl]) (p < 0.001 compared with placebo). Effic acy of pravastatin was maintained at 26 weeks, and during this initial period there were significantly more serious cardiovascular adverse e vents in the placebo group (13 events, 2.4%) than in the pravastatin g roup (1 event, 0.2%) (p < 0.001). Six myocardial infarctions, 5 cases of unstable angina and 1 sudden cardiac death occurred in the placebo group, compared with none of these events in the pravastatin group. In this study, pravastatin produced beneficial effects on serum lipids a nd was associated with a reduction in the incidence of serious cardiov ascular adverse events.