LONG-TERM EFFICACY AND TOLERABILITY OF PRAVASTATIN IN HYPERCHOLESTEROLEMIA IN PATIENTS WITH NON-INSULIN-DEPENDENT DIABETES-MELLITUS

This study reports the result of a 12-month, open-label multicenter st udy of the efficacy and tolerability of pravastatin in the management of hypercholesterolemia associated with non-insulin-dependent diabetes mellitus. Pravastatin produced a decrease, in 138 diabetic and 51 non -diabetic patients, in total serum cholesterol by 19 and 20%, in low-d ensity lipoprotein (LDL) cholesterol by 25 and 29%, in apolipoprotein B by 15 and 19% and in triglycerides by 8 and 5%, respectively, High-d ensity lipoprotein cholesterol levels were increased by 9% in both gro ups. All of these changes were significant (P < 0.001) except for trig lycerides changes in non-diabetic patients, where the change was not s ignificant and no significant differences were observed between the tw o groups, These favorable effects on LDL cholesterol and apolipoprotei n B were not influenced by gender, the type of diabetic therapy, basel ine hemoglobin A(lc) levels and by the presence of hypertension or gro ss proteinuria, although a decrease in the two variables were less in those with body mass index greater than or equal to 26.4 kg/m(2) or in those with age < 60 years, Adverse experiences were similar between t reatment groups and the drug was well tolerated, Only one diabetic pat ient was withdrawn from the study because of pruritis, Pravastatin pro duced no change in fasting plasma glucose concentrations and hemoglobi n A(lc) levels in diabetic patients throughout the study, Pravastatin was generally effective in improving the serum lipids of hypercholeste rolemic diabetic patients.