title: A Randomized Open-Label Trial to Assess the Effect of Plant Sterols Associated with Ezetimibe in Low-Density Lipoprotein Levels in Patients with Coronary Artery Disease on Statin Therapy.
abstract: Consumption of food products enriched with plant sterols and the use of ezetimibe reduce cholesterol absorption in the intestine and effectively reduce low-density lipoprotein (LDL) plasma levels. We evaluated the therapeutic effect of the ezetimibe+plant sterol association in patients with coronary artery disease still not reaching recommended lipid levels despite the use of statins. We performed a prospective open-label study with 41 patients with stable coronary disease and LDL >70 mg/dL. Patients were randomized into four groups for a 6-week treatment: the control (CT) group remained on the same statin therapy, the ezetimibe (EZ) group received 10 mg/day of ezetimibe, the plant sterol (PS) group received spread enriched with 2 g of plant sterols, and the ezetimibe+PS (EZ+PS) group received 10 mg/day EZ +2 g PS. Initial mean LDL level was 97.4 ± 31.1 mg/dL in control group, 105.1 ± 23.1 mg/dL in EZ group, 95.4 ± 27.7 mg/dL in PS group, and 97.0 ± 8.3 mg/dL in EZ+PS group (P > .05). After 6 weeks of treatment, LDL of patients slightly increased in the control group (+8.9%; P > .05) and dropped in EZ group (-19.1%; P = .06), PS group (-16.6%; P = .01), and EZ+PS group (-27.3%; P < .01). Mean LDL levels after treatment were 70.5 ± 17.9 mg/dL in EZ+PS group, lower than the other groups (control was 106.1 ± 34.9 mg/dL, EZ group was 85.0 ± 35.6 mg/dL, and PS was 79.6 ± 29.7 mg/dL) (P = .05 variance analysis factor [ANOVA]). Body weight, body-mass index, and glucose plasma levels did not change significantly after intervention. The combination of PS+ezetimibe was associated with lower LDL levels and suggests beneficial therapeutic effect against major cardiovascular events.
authors.affiliation: School of Medicine, Pontificia Universidade Catolica do Parana , Curitiba, Brazil .
authors.forename: Gisane Biacchi
authors.initials: GB
authors.lastname: Gomes
authors.affiliation: School of Medicine, Pontificia Universidade Catolica do Parana , Curitiba, Brazil .
authors.forename: Ana Denise
authors.initials: AD
authors.lastname: Zazula
authors.affiliation: School of Medicine, Pontificia Universidade Catolica do Parana , Curitiba, Brazil .
authors.forename: Leonardo Seidi
authors.initials: LS
authors.lastname: Shigueoka
authors.affiliation: School of Medicine, Pontificia Universidade Catolica do Parana , Curitiba, Brazil .
authors.forename: Rosangela Alquieri
authors.initials: RA
authors.lastname: Fedato
authors.affiliation: School of Medicine, Pontificia Universidade Catolica do Parana , Curitiba, Brazil .
authors.forename: Ana Beatriz Brenner Affonso
authors.initials: AB
authors.lastname: da Costa
authors.affiliation: School of Medicine, Pontificia Universidade Catolica do Parana , Curitiba, Brazil .
authors.forename: Luiz Cesar
authors.initials: LC
authors.lastname: Guarita-Souza
authors.affiliation: School of Medicine, Pontificia Universidade Catolica do Parana , Curitiba, Brazil .
authors.forename: Cristina Pellegrino
authors.initials: CP
authors.lastname: Baena
authors.affiliation: School of Medicine, Pontificia Universidade Catolica do Parana , Curitiba, Brazil .
authors.forename: Marcia
authors.initials: M
authors.lastname: Olandoski
authors.affiliation: School of Medicine, Pontificia Universidade Catolica do Parana , Curitiba, Brazil .
authors.forename: José Rocha
authors.initials: JR
authors.lastname: Faria-Neto
mesh_terms: D000328:Adult; D000368:Aged; D000924:Anticholesteremic Agents / Q000627:therapeutic use; D003324:Coronary Artery Disease / Q000097:blood / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D000069438:Ezetimibe / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D008077:Lipoproteins, LDL / Q000097:blood*; D008297:Male; D008875:Middle Aged; D010840:Phytosterols / Q000008:administration & dosage*; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D000924:Anticholesteremic Agents; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D008077:Lipoproteins, LDL; D010840:Phytosterols; D000069438:Ezetimibe
keywords: 3-hydroxy-3-methylglutaryl-coenzyme A reductase; Cardiovascular damage; LDL oxidation; Phytosterols