EFFICACY OF PRAVASTATIN IN THE TREATMENT OF HYPERCHOLESTEROLEMIA IN CLINICAL-PRACTICE

This multicenter, open-label, uncontrolled study of the efficacy and safety of pravastatin was performed under the usual conditions of routine clinical practice; 153 physicians from several cities in Mexico participated. Pravastatin was administered in dosages of 10 mg/day over four weeks and 10 or 20 mg/day for four additional weeks to 1,087 patients with a plasma total cholesterol level of at least 240 mg/dl following two weeks of dietary therapy. There were 511 men and 576 women with an average age of 50 and 54 years, respectively. A large proportion had an associated medical condition such as obesity, diabetes mellitus, hypertension, low plasma high-density lipoprotein (HDL) levels, or coronary heart disease, which required other medications for their management. Significant reductions in plasma levels of total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides (P < 0.001) were observed after four and eight weeks of pravastatin administration, associated with an increase in HDL cholesterol plasma concentration (P < 0.05). The average percent reductions in total cholesterol levels after four and eight weeks of treatment were 19% and 27%, respectively; LDL cholesterol decreased 25% and 37%, respectively, and triglycerides 17% and 25%, respectively. HDL cholesterol increased 4% and 7%, respectively. During treatment 76 patients (6.9%) developed various adverse reactions. The most frequently reported had an incidence of no more than 0.8% and included nausea, headache, dry mouth, dizziness, and skin rash. Five patients had asymptomatic elevations of serum creatine kinase and two of serum alanine aminotransferase. The observed efficacy and safety of pravastatin in routine clinical practice are similar to those previously recorded in controlled clinical trials.