Additive effect of plant sterol-ester margarine and cerivastatin in lowering low-density lipoprotein cholesterol in primary hypercholesterolemia.
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.
D001053:Apolipoproteins / Q000097:blood; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D018752:Diet, Fat-Restricted; D004041:Dietary Fats / Q000008:administration & dosage; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000178:diet therapy / Q000188:drug therapy*; D008297:Male; D008383:Margarine; D008875:Middle Aged; D009517:New South Wales; D010840:Phytosterols / Q000008:administration & dosage*; D011725:Pyridines / Q000008:administration & dosage / Q000627:therapeutic use*; D011793:Queensland; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
D001053:Apolipoproteins; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D004041:Dietary Fats; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D010840:Phytosterols; D011725:Pyridines; D014280:Triglycerides; D008383:Margarine; D002784:Cholesterol; C086276:cerivastatin