KMID : 1161420170200010030
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Journal of Medicinal Food 2017 Volume.20 No. 1 p.30 ~ p.36
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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
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Gomes Gisane Biacchi
Zazula Ana Denise Shigueoka Leonardo Seidi Fedato Rosangela Alquieri da Costa Ana Beatriz Brenner Affonso Guarita-Souza Luiz Cesar Baena Cristina Pellegrino Olandoski Marcia Faria-Neto Jose Rocha
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Abstract
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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?¡¾?31.1?mg/dL in control group, 105.1?¡¾?23.1?mg/dL in EZ group, 95.4?¡¾?27.7?mg/dL in PS group, and 97.0?¡¾?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?¡¾?17.9?mg/dL in EZ+PS group, lower than the other groups (control was 106.1?¡¾?34.9?mg/dL, EZ group was 85.0?¡¾?35.6?mg/dL, and PS was 79.6?¡¾?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.
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KEYWORD
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Cardiovascular damage, LDL oxidation, Phytosterols, 3-hydroxy-3-methylglutaryl-coenzyme A reductase
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