A multicenter study to compare safety, tolerability and efficacy of lovastatin and gernfibrozil in monotherapy or in combination with cholestyramine in patients with primary hypercholesterolemia

BACKGROUND: The well-known relationship between high plasma cholesterol levels and coronary heart disease makes the treatment of primary hypercholesterolemia an important issue. PATIENTS AND METHODS: A randomized, double-blind 12 week study to compare lovastatin (20-80 mg/day) and gemfibrozil (600 mg b.i.d.) was performed in 59 patients with primary 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-cholesterol exceeded 165 mg/dl at week 12. RESULTS: Total cholesterol, triglycérides and LDL-cholesterol decreased significantly (23.8%, 16.4% and 30.9%, respectively) after lovastatin therapy, whereas HDL-cholesterol increased (13.9%). The figures for the group treated with gemfibrozil were 12.8%, 30.3%, 17.2% and 14.6%, respectively. Mean changes between the two groups were statistically significant for all parameters except for HDL-cholesterol. LDL-cholesterol decreased below 165 mg/dl in 69% of patients receiving lovastatin and 36.7% of patients treated with gemfibrozil (p < 0.05). During the second phase there were no additional significant changes in the 9 patients of the lovastatin group 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 patients treated with gemfibrozil alone or in combination with cholestyramine. CONCLUSIONS: In patients with primary hipercholesterolemia, lovastatin alone or in combination with cholestyramine was more effective than gemfibrozil alone or in combination with cholestyramine to tower total cholesterol and LDL-cholesterol. The effect of both drugs on HDL-cholesterol was similar.