[Pravastatin multicenter clinical trial in patients with hypercholesterolemia and multiple risk factors]

To study whether pravastatin maintain its therapeutic effect when the treatment is indicated to patients with hypercholesterolemy associated to others risk factors.

In a multicenter investigation 1147 patients, mostly male (609) with a mean age of 52 years were enrolled. The inclusion criteria were cholesterol level above 260 mg/dL or 220 mg/dL if LDL-C greater than 145 mg/dL and one or more risk factors. The patients were treated for 16 weeks, in the first four only with diet orientation and with diet plus 10 mg of pravastatin in the 12 subsequent weeks.

Hypertension and smoke were the more frequent risk factors observed in the study population. Only 22% of the patients were on hypolipemiant treatment before enrolling in the study. HDL-C was unchanged and total and LDL-C presented a reduction of approximately 10% with diet orientation. After 10 mg of pravastatin there was a reduction of around 30% of total and LDL-C and a 13% HDL-C elevation. The presence of risk factors did not influence significantly the drug effect, but it is possible to observe that those who smoke and males had lower levels of HDL-C. Obesity and diabetes patients presented greater levels of triglycerides. Therapeutic response to pravastatin is slightly smaller in males and after menopause.

The number of patients following regular hypolipemiant treatment is still small(22%). Risk factors associated to hypercholesterolemia do not seem to interfere in the lipid lowering response to pravastatin. Pravastatin 10 mg once a day controlled hypercholesterolemia in 85% of the study population.