Incremental reduction of serum total cholesterol and low-density lipoprotein cholesterol with the addition of plant stanol ester-containing spread tostatin therapy

This study compares the effect of plant stanol ester spread with a placebo spread on cholesterol in patients taking statin therapy, but who still had elevated low-density lipoprotein (LDL) cholesterol. This was a randomized, double-blind, placebo-controlled clinical trial, with 67 women and 100 men with LDL cholesterol greater than or equal to 130 mg/dl and triglycerides l ess than or equal to 350 mg/dl who had been taking a stable dose of a stati n drug for at least 90 days before the start of the study. For 8 weeks, par ticipants consumed 3 servings/day of the plant stanol ester spread that pro vided 5.1 g/day of plant stanol ester or a placebo. The addition of plant s tanol ester spread significantly reduced total cholesterol and LDL choleste rol at 2, 4, and 8 weeks when compared with placebo spread. Plant stanol es ter spread reduced total cholesterol at 8 weeks by 12% compared with a plac ebo reduction of 5% (-7% difference; p <0.0001). Plant stanol ester spread reduced LDL cholesterol at 8 weeks by 17% compared with a 7% reduction in t he placebo group (-10% difference, p <0.0001). The absolute reduction in LD L cholesterol at 8 weeks was 24 and 10 mg/dl in the stanol ester and placeb o groups, respectively. The plant stanol ester spread group also had greate r reductions in both serum total cholesterol and LDL cholesterol than the p lacebo group at 2 and 4 weeks (p <0.001 for all comparisons). Both spreads were well tolerated by study participants, and no significant adverse event s were noted. Consumption of spread that provided 5.1 g/day of plant stanol esters effectively reduced elevated total and LDL cholesterol levels in pa rticipants on a stable regimen of a statin. (C) 2000 by Excerpta Medico, In c.