Additive Effect of Plant Sterol-Ester Margarine and Cerivastatin in Lowering Low-Density Lipoprotein Cholesterol in Primary Hypercholesterolemia

Am J Cardiol. 2002 Oct 1;90(7):737-40. doi: 10.1016/s0002-9149(02)02600-0.

Abstract

The objective of this study was to evaluate whether plant sterol-ester margarine has an additive or interactive effect on low-density lipoprotein (LDL) cholesterol reduction when ingested in combination with a statin drug. This was a multicenter, randomized, double-blind study with 4 parallel treatment arms in a balanced 2 x 2 factorial design. The 4 daily treatment options were: (1) placebo plus regular margarine 25 g (n = 38); (2) placebo plus sterol-ester margarine 25 g (2 g of plant sterol) (n = 39); (3) cerivastatin 400 microg plus regular margarine 25 g (n = 38); and (4) cerivastatin 400 microg plus sterol-ester margarine 25 g (n = 37). The study was conducted in men and women with primary hypercholesterolemia with baseline LDL cholesterol >/=97 mg/dl (mean 206). The primary efficacy parameter was the percent change in LDL cholesterol between baseline and at the end of 4 weeks' treatment. Cerivastatin (vs placebo) reduced LDL cholesterol by 32% (95% confidence intervals 28% to 36%, p <0.0001) and sterol-ester margarine (vs regular margarine) by 8% (95% confidence interval 4% to 12%, p <0.0001). The effect of sterol-ester margarine and cerivastatin together was additive (39% reduction in LDL cholesterol), but there was no significant interactive effect between sterol-ester margarine and cerivastatin (p = 0.29). The treatments were generally well tolerated with no major differences in adverse events between groups. In subjects with primary hypercholesterolemia, statin and sterol-ester margarine used together produce a purely additive effect on LDL cholesterol reduction. The addition of sterol-ester margarine to statin therapy offers LDL cholesterol reduction equivalent to doubling the dose of statin.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Apolipoproteins / blood
  • Cholesterol / blood
  • Cholesterol, HDL / blood
  • Cholesterol, LDL / blood
  • Diet, Fat-Restricted*
  • Dietary Fats / administration & dosage
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use*
  • Hypercholesterolemia / diet therapy
  • Hypercholesterolemia / drug therapy*
  • Male
  • Margarine
  • Middle Aged
  • New South Wales
  • Phytosterols / administration & dosage*
  • Pyridines / administration & dosage
  • Pyridines / therapeutic use*
  • Queensland
  • Treatment Outcome
  • Triglycerides / blood

Substances

  • Apolipoproteins
  • Cholesterol, HDL
  • Cholesterol, LDL
  • Dietary Fats
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Phytosterols
  • Pyridines
  • Triglycerides
  • Margarine
  • Cholesterol
  • cerivastatin