Efecto a largo plazo de los estanoles vegetales en el perfil lipídico de pacientes con hipercolesterolemia. Ensayo clínico aleatorizado / Long-term effects of plant stanols on the lipid profile of patients with hypercholesterolemia. A randomized clinical trial

Introducción y objetivos. El consumo de estanoles vegetales puede contribuir a un mejor control a largo plazo del colesterol. El objetivo es evaluar la eficacia del aporte de estanoles vegetales, a dosis de 2 g/día, en la reducción de las cifras de colesterol unido a lipoproteínas de baja densidad de los pacientes con hipercolesterolemia. Métodos. Se realizó un ensayo clínico aleatorizado, a doble ciego y controlado con placebo, en el que se incluyó a 182 sujetos adultos diagnosticados de hipercolesterolemia. Se administró yogur líquido con 2 g de estanoles vegetales a 91 sujetos del grupo intervención y yogur no suplementado a 91 del grupo control. La variable principal fue la variación del perfil lipídico a los 12 meses. Resultados. En comparación con el placebo, a los 12 meses se observó una disminución significativamente superior del colesterol unido a lipoproteínas de baja densidad en el grupo que tomó estanoles: 13,7 (intervalo de confianza del 95%, 3,2-24,1) mg/dl (p = 0,011). En este grupo fue significativamente superior la proporción de sujetos que redujeron en más del 10% sus cifras de colesterol unido a lipoproteínas de baja densidad (riesgo relativo = 1,7; intervalo confianza del 95%, 1,1-2,7). En el grupo tratado, el colesterol unido a lipoproteínas de baja densidad descendió, en promedio, un 11,0 ± 23,9%. Conclusiones. Los resultados confirman que la administración de estanoles vegetales en dosis de 2 g/día durante 1 año produce una reducción significativa (ligeramente superior al 10%) de las concentraciones de colesterol unido a lipoproteínas de baja densidad en sujetos con hipercolesterolemia (AU)

Introduction and objectives. Plant stanol consumption may improve long-term cholesterol control. The aim of the present study was to evaluate the effectiveness of 2 g/day of plant stanols in reducing low-density lipoprotein cholesterol levels in patients with hypercholesterolemia. Methods. This randomized, double-blind, and placebo-controlled study included 182 adults diagnosed with hypercholesterolemia. A yogurt drink containing 2 g of plant stanols was administered to 91 participants in the intervention group; 91 participants in the control group received unsupplemented yogurt. The primary end point was the change in the lipid profile at 12 months. Results. Low-density lipoprotein cholesterol levels at 12 months were significantly more reduced in the stanol intervention group than in the control group: 13.7 (95% confidence interval, 3.2-24.1) mg/dL (P = .011). A reduction of more than 10% in low-density lipoprotein cholesterol was achieved by a significantly higher proportion of participants in the intervention group (relative risk = 1.7; 95% confidence interval, 1.1-2.7). In this group, the mean (standard deviation) level of low-density lipoprotein cholesterol decreased by 11.0% (23.9%). Conclusions. Our results confirm that administration of plant stanols at a dosage of 2 g/day for 12 months significantly reduces (by slightly more than 10%) the concentrations of low-density lipoprotein cholesterol in individuals with hypercholesterolemia (AU)

Regulatory approval of plant sterols in Canada: implications for health care and clinical practice.

Health Canada's recent approval of plant sterols as food ingredients to decrease low-density lipoprotein cholesterol (LDL-C) is believed to be a significant step toward improving Canadians' cardiovascular health and reducing the economic burden of heart disease. When dyslipidemic patients consume plant sterols at a recommended daily dose of 2 g, they can reduce LDL-C by 10% to 15%, with no deleterious effects on high-density lipoprotein cholesterol. A 10% LDL-C reduction in response to plant sterol consumption is projected to reduce heart disease risk by 25%. Because they are available without a prescription, plant sterols are an option for dietitians who wish to provide cholesterol-lowering guidance beyond traditional dietary advice (i.e., lowering saturated fat intake and restricting dietary cholesterol). In addition, plant sterols can be used in combination with a statin or when statin use is contraindicated, and they have recently emerged as a potentially valuable triglyceride-lowering option. However, the projected improvement in public health and health care savings will be realized only if impediments to daily use are removed. One such impediment is the higher cost of fortified food products, such as yogurt and margarine. If the cost of plant sterol food products is to decline, cost-effective sources must be investigated and a larger range of foods containing plant sterols must be made available.