Comparison of the efficacy, safety and tolerability of simvastatin and pravastatin for hypercholesterolemia. The Simvastatin Pravastatin Study Group.

The efficacy and safety profile of simvastatin and pravastatin across their most commonly recommended dosage ranges were compared in a double-blind, parallel, multicenter study in 550 patients with primary hypercholesterolemia. The study consisted of a 6-week placebo period followed by 18 weeks of active treatment. Patients were randomized to 10 mg of simvastatin or pravastatin once in the evening; doses were titrated at 6-week intervals to a maximum of 40 mg/day if the low-density lipoprotein (LDL) cholesterol remained > or = 130 mg/dl (3.4 mmol/liter). Baseline characteristics were similar in both groups. At the end of the study with simvastatin and pravastatin, respectively, 30 and 14% continued to take the 10 mg dose and 48 and 66% were titrated to the maximal dose. After 18 weeks of treatment with simvastatin and pravastatin the mean percent decreases from baseline were, respectively, for total plasma cholesterol 27 and 19% (p < 0.01 between groups), for LDL cholesterol 38 and 26% (p < 0.01 between groups), for very low density lipoprotein cholesterol 30 and 16% (p < 0.01 between groups), and for triglycerides 18 and 14% (p < 0.05 between groups). The mean percent increase from baseline in high-density lipoprotein cholesterol was 15% with simvastatin compared to 12% with pravastatin (p < 0.05 between groups). The efficacy goal of LDL cholesterol < 130 mg/dl was achieved in 65% of the patients treated with simvastatin versus 39% of those treated with pravastatin (p < 0.001). There was no significant difference between groups in the frequency of drug-related adverse experiences.(ABSTRACT TRUNCATED AT 250 WORDS)