Efficacy and tolerability of simvastatin and pravastatin in patients with primary hypercholesterolemia (multicountry comparative study). The European Study Group.

A total of 291 patients with primary hypercholesterolemia [total plasma cholesterol > or = 6.20 mmol/liter (> or = 240 mg/dl)] were enrolled in an open, randomized, parallel, comparative study of simvstatin and pravastatin. All patients started or continued a standard lipid-lowering diet for > or = 6 weeks before entry into the 4-week placebo baseline period. There were 145 patients who received simvastatin and 146 patients who received pravastatin, both at the commonly recommended starting dose of 10 mg once daily, for a treatment period of 6 weeks. Concentrations of total cholesterol in plasma were reduced by 23% with simvastatin, and by 16% with pravastatin. Concentrations of low-density lipoprotein cholesterol in plasma were reduced by 32 and 22%, and high-density lipoprotein cholesterol concentrations were increased by 7 and 5% with simvastatin and pravastatin, respectively. Plasma triglyceride concentrations were reduced by 13% with simvastatin and by 6% with pravastatin. Adverse experiences were similar between treatment groups and both drugs were well tolerated. In each treatment group, 3 patients were withdrawn from the study for clinical adverse experiences; 1 patient in the pravastatin group required a reduction in dose to 5 mg/day because of insomnia. At the commonly recommended starting dose for each, simvastatin had a significantly greater lipid-lowering effect than pravastatin. Both drugs were well tolerated.