A MULTICENTER STUDY TO COMPARE SAFETY, TO LERABILITY AND EFFICACY OF LOVASTATIN AND GEMFIBROZIL IN MONOTHERAPY OR IN COMBINATION WITH CHOLESTYRAMINE IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA

BACKGROUND: The well-known relationship between high plasma cholestero l levels and coronary heart disease makes the treatment of primary hyp ercholesterolemia an important issue. PATIENTS AND METHODS: A randomiz ed, double-blind 12 week study to compare lovastatin (20-80 mg/day) an d gemfibrozil (600 mg b.i.d.) was performed in 59 patients with primar y hypercholesterolemia. Resincholestyramine was started on week 12, at a dose of 8-16 g/day for the next 12 weeks in any patient whose LDL-c holesterol exceeded 165 mg/dl at week 12. RESULTS: Total cholesterol, triglycerides and LDL-cholesterol decreased significantly (23.8%, 16.4 % and 30.9%, respectively) after lovastatin therapy, whereas HDL-chole sterol increased (13.9%). The figures for the group treated with gemfi brozil were 12.8%, 30.3%, 17.2% and 14.6%, respectively. Mean changes between the two groups were statistically significant for all paramete rs except for HDL-cholesterol. LDL-cholesterol decreased below 165 mg/ dl in 69% of patients receiving lovastatin and 36.7% of patients treat ed with gemfibrozil (p < 0.05). During the second phase there were no additional significant changes in the 9 patients of the lovastatin gro up and the 20 patients of the gemfibrozil group after cholestyramine, but LDL-cholesterol decreased below 165 mg/dl in 5 patients (55%) and 6 patients (30%), respectively. Side effects were more prevalent in pa tients treated with gemfibrozil alone or in combination with cholestyr amine. CONCLUSIONS: In patients with primary hipercholesterolemia, lov astatin alone or in combination with cholestyramine was more effective than gemfibrozil alone or in combination with cholestyramine to lower total cholesterol and LDL-cholesterol. The effect of both drugs on HD L-cholesterol was similar.