[Multicenter comparative study on safety, tolerance, and effectiveness of lovastatin combined or not with cholestyramine, and gemfibrozil combined or not with cholestyramine in the treatment of 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, triglycerides 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 hypercholesterolemia, lovastatin 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 HDL-cholesterol was similar.