title: Additive effects of plant sterols supplementation in addition to different lipid-lowering regimens.
abstract: OBJECTIVE
  Plant sterol (PS) supplementation has been widely used alone or combined with lipid-lowering therapies (LLTs) to reduce low-density lipoprotein (LDL) cholesterol. The effects of PS added to high-intensity LLT are less reported, especially regarding the effects on cholesterol synthesis and absorption.
  
  
  METHODS
  A prospective, randomized, open-label study, with parallel arms and blinded end points was designed to evaluate the effects of addition of PS to LLT on LDL cholesterol, markers of cholesterol synthesis, and absorption. Eighty-six patients of both genders were submitted to a 4-wk run-in period with atorvastatin 10 mg (baseline). Following, subjects received atorvastatin 40 mg, ezetimibe 10 mg, or combination of both drugs for another 4-wk period (phase I). In phase II, capsules containing 2.0 g of PSs were added to previous assigned treatments for 4 wk. Lipids, apolipoproteins, plasma campesterol, β-sitosterol, and desmosterol levels were assayed at all time points. Within and between-group analyses were performed.
  
  
  RESULTS
  Compared with baseline, atorvastatin 40 mg reduced total and LDL cholesterol (3% and 22%, respectively, P < .05), increased β-sitosterol, campesterol/cholesterol, and β-sitosterol/cholesterol ratios (39%, 47%, and 32%, respectively, P < .05); ezetimibe 10 mg reduced campesterol and campesterol/cholesterol ratio (67% and 70%, respectively, P < .05), and the combined therapy decreased total and LDL cholesterol (22% and 38%, respectively, P < .05), campesterol, β-sitosterol, and campesterol/cholesterol ratio (54%, 40%, and 27%, P < .05). Addition of PS further reduced total and LDL cholesterol by ∼ 7.7 and 6.5%, respectively, in the atorvastatin therapy group and 5.0 and 4.0% in the combined therapy group (P < .05, for all), with no further effects in absorption or synthesis markers.
  
  
  CONCLUSIONS
  PS added to LLT can further improve lipid profile, without additional effects on intestinal sterol absorption or synthesis.
authors.affiliation: Cardiology Division, Department of Medicine, Federal University of Sao Paulo, Sao Paulo, Brazil.
authors.forename: Daniela M T
authors.initials: DM
authors.lastname: Malina
authors.affiliation: Cardiology Division, Department of Medicine, Federal University of Sao Paulo, Sao Paulo, Brazil.
authors.forename: Francisco A
authors.initials: FA
authors.lastname: Fonseca
authors.affiliation: Cardiology Division, Department of Medicine, Federal University of Sao Paulo, Sao Paulo, Brazil.
authors.forename: Sílvio A
authors.initials: SA
authors.lastname: Barbosa
authors.affiliation: Cardiology Division, Department of Medicine, Federal University of Sao Paulo, Sao Paulo, Brazil.
authors.forename: Soraia H
authors.initials: SH
authors.lastname: Kasmas
authors.affiliation: Cardiology Division, Department of Medicine, Federal University of Sao Paulo, Sao Paulo, Brazil.
authors.forename: Valéria A
authors.initials: VA
authors.lastname: Machado
authors.affiliation: Health Sciences Post-Graduation Division, University of Santo Amaro-UNISA, Sao Paulo, Brazil.
authors.forename: Carolina N
authors.initials: CN
authors.lastname: França
authors.affiliation: Synchrophar, Campinas, Sao Paulo, Brazil.
authors.forename: Ney C
authors.initials: NC
authors.lastname: Borges
authors.affiliation: Synchrophar, Campinas, Sao Paulo, Brazil.
authors.forename: Ronilson A
authors.initials: RA
authors.lastname: Moreno
authors.affiliation: Cardiology Division, Department of Medicine, Federal University of Sao Paulo, Sao Paulo, Brazil. Electronic address: mcoizar@terra.com.br.
authors.forename: Maria C
authors.initials: MC
authors.lastname: Izar
mesh_terms: D000368:Aged; D000924:Anticholesteremic Agents / Q000008:administration & dosage*; D001053:Apolipoproteins / Q000097:blood; D000069059:Atorvastatin / Q000008:administration & dosage; D002784:Cholesterol / Q000031:analogs & derivatives / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D019587:Dietary Supplements; D004357:Drug Synergism; D000069438:Ezetimibe / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D050356:Lipid Metabolism / Q000187:drug effects; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D010840:Phytosterols / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D012855:Sitosterols / Q000097:blood
chemical_list: D000924:Anticholesteremic Agents; D001053:Apolipoproteins; D008078:Cholesterol, LDL; D008055:Lipids; D010840:Phytosterols; D012855:Sitosterols; C021273:campesterol; C025473:gamma-sitosterol; D002784:Cholesterol; D000069059:Atorvastatin; D000069438:Ezetimibe
keywords: Atorvastatin; Cholesterol absorption; Cholesterol synthesis; Ezetimibe; Phytosterols