Treatment of severe hypercholesterolemia with a combination of beta-sitosterol and lovastatin

Abstract

The objective of this study was to determine whether adding the plant sterol beta-sitosterol to a lipid-lowering treatment regimen of lovastatin further decreases low-density lipoprotein (LDL) cholesterol. Thirty patients (16 men, 14 women) with a mean age of 45 ± 13 years, LDL cholesterol levels between 5.89 and 12.26 mmol/L, and triglyceride levels <2.82 mmol/L were randomly assigned to one of two study groups: group L (n = 15), which received lovastatin alone, and group LS (n = 15), which received lovastatin and beta-sitosterol. All patients were first treated for 16 weeks with the maximally tolerable dose of lovastatin. Beta-sitosterol 6 g/d was then added to the treatment regimen of group LS for 12 weeks, while group L continued with lovastatin alone. In the beta-sitosterol group, mean LDL cholesterol decreased by an additional 12.8% to 15.1%, a significant difference from the corresponding change in the group receiving lovastatin alone. After discontinuation of beta-sitosterol, LDL cholesterol increased again. The decrease in LDL and total cholesterol before the addition of beta-sitosterol was comparable in the two groups: the mean reduction in LDL cholesterol was 30.4% in group L and 25.8% in group LS; total cholesterol was decreased by 24.2% in group L and 21.1% in group LS. After the addition of beta-sitosterol, the total decrease in LDL cholesterol was 35.3% to 37.1%; the decrease in total cholesterol was 27.3% to 29.2%. No significant changes were observed in other lipid variables such as high-density lipoprotein cholesterol, lipoprotein(a), very-low-density lipoprotein triglycerides and cholesterol, apolipoprotein A-I, and lecithin-cholesterol acyltransferase activity.